Sunday, May 15, 2011
Friday, May 13, 2011
http://yahoo.brand.edgar-online.com/default.aspx?cik=1416876
Most recent filings and form 3 information.
Friday, April 29, 2011
Medicare to Pay for MRIs in Patients With Pacemakers
WASHINGTON -- The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is strong enough to reimburse for MRI exams in Medicare patients who have permanent pacemakers.
"We propose to change the language ... of the NCD Manual to remove the contraindication for Medicare coverage of MRI in beneficiaries with implanted PMs [permanent pacemakers] when the PMs are used according to the FDA-approved labeling for use in an MRI environment," the agency's proposed decision memorandum states.
The FDA approved the first MRI-conditional pacemaker (Medtronic Revo MRI SureScan Pacing System) on Feb. 8, but CMS specifically noted that the change in payment policy "does not include any coverage determination about the Medtronic Revo MRI SureScan Pacing System itself or any other pacemaker."
The proposed coverage is not limited to any specific disease or condition.
The new decision broadens one announced on Feb. 24, when CMS said it would cover MRI exams only for patients with pacemakers if they were enrolled in approved clinical studies of MRI.
The next day, CMS received a request letter from Medtronic referencing the randomized controlled trial of 464 pacemaker patients demonstrating the safety of the device in the MR environment and provided CMS with a reference to the journal in which the study was published.
"The requester asked that CMS remove completely the contraindication in the MRI policy for patients with pacemaker devices that have been approved by the FDA for use in the MR environment," according to the CMS decision memorandum.
Following a 30-day public comment period regarding coverage of MRI scans in patients with pacemakers, CMS concluded that "this use of MRI is reasonable and necessary."
"We propose to change the language ... of the NCD Manual to remove the contraindication for Medicare coverage of MRI in beneficiaries with implanted PMs [permanent pacemakers] when the PMs are used according to the FDA-approved labeling for use in an MRI environment," the agency's proposed decision memorandum states.
The FDA approved the first MRI-conditional pacemaker (Medtronic Revo MRI SureScan Pacing System) on Feb. 8, but CMS specifically noted that the change in payment policy "does not include any coverage determination about the Medtronic Revo MRI SureScan Pacing System itself or any other pacemaker."
The proposed coverage is not limited to any specific disease or condition.
The new decision broadens one announced on Feb. 24, when CMS said it would cover MRI exams only for patients with pacemakers if they were enrolled in approved clinical studies of MRI.
The next day, CMS received a request letter from Medtronic referencing the randomized controlled trial of 464 pacemaker patients demonstrating the safety of the device in the MR environment and provided CMS with a reference to the journal in which the study was published.
"The requester asked that CMS remove completely the contraindication in the MRI policy for patients with pacemaker devices that have been approved by the FDA for use in the MR environment," according to the CMS decision memorandum.
Following a 30-day public comment period regarding coverage of MRI scans in patients with pacemakers, CMS concluded that "this use of MRI is reasonable and necessary."
Saturday, April 23, 2011
FDA Clears First MRI-Safe Pacemaker
FDA Clears First MRI-Safe Pacemaker
WASHINGTON -- A cardiac pacemaker that's safe for patients who need an MRI scan has won FDA approval, although the device comes with limitations on which patients and which scans are compatible with it.
The Revo MRI SureScan pacemaker, made by Medtronic, is the first such device to receive marketing clearance in the U.S.
According to the company, the product comes with special leads and other design features that reduce or eliminate certain hazards associated with the MRI environment.
The scanners produce powerful magnetic forces that react with ferric metals and induce electrical currents in electronic components. MRI machines also emit radiofrequency energy that may interact with pacemakers.
As a result, MRI scans can disrupt pacemaker settings or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.
Until now, most MRI scans have been contraindicated for patients with pacemakers. About half of such patients have conditions that would ordinarily call for MRI scans, according to the FDA.
Among the features included in the Revo MRI product is a function to be switched on prior to undergoing an MRI to eliminate problems associated with induced currents and radiofrequency emissions.
The FDA's approval rates the device as "MRI-conditional," meaning that it is safe with MRI scans under certain conditions.
Announcements from the FDA and the company didn't indicate specifically what those conditions would be. Medtronic officials did not respond immediately to a request for details.
However, the major clinical trial underpinning the approval -- presented at a meeting in 2009 and published last month -- only tested the device with MRI machines of no more than 1.5 Tesla and the scanning isocenters were located above the cervical spine or below the thoracic spine.
In the trial, 464 patients received the Revo device and were randomized 1:1 to receive an MRI or not. No scan-related complications were seen in patients who had the scans.
The Revo MRI SureScan pacemaker must be used with special leads designed for the system.
The approval was delayed while the company sought to improve conditions at its Mounds View, Minn., manufacturing plant where its pacemakers are produced. The FDA issued a warning letter about the plant in November 2009 and has not yet declared the problems fully resolved.
Medtronic said it is continuing to work with the agency to satisfy its concerns.
http://www.medicalbillingassistanceinc.com/
The Revo MRI SureScan pacemaker, made by Medtronic, is the first such device to receive marketing clearance in the U.S.
According to the company, the product comes with special leads and other design features that reduce or eliminate certain hazards associated with the MRI environment.
The scanners produce powerful magnetic forces that react with ferric metals and induce electrical currents in electronic components. MRI machines also emit radiofrequency energy that may interact with pacemakers.
As a result, MRI scans can disrupt pacemaker settings or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.
Until now, most MRI scans have been contraindicated for patients with pacemakers. About half of such patients have conditions that would ordinarily call for MRI scans, according to the FDA.
Among the features included in the Revo MRI product is a function to be switched on prior to undergoing an MRI to eliminate problems associated with induced currents and radiofrequency emissions.
The FDA's approval rates the device as "MRI-conditional," meaning that it is safe with MRI scans under certain conditions.
Announcements from the FDA and the company didn't indicate specifically what those conditions would be. Medtronic officials did not respond immediately to a request for details.
However, the major clinical trial underpinning the approval -- presented at a meeting in 2009 and published last month -- only tested the device with MRI machines of no more than 1.5 Tesla and the scanning isocenters were located above the cervical spine or below the thoracic spine.
In the trial, 464 patients received the Revo device and were randomized 1:1 to receive an MRI or not. No scan-related complications were seen in patients who had the scans.
The Revo MRI SureScan pacemaker must be used with special leads designed for the system.
The approval was delayed while the company sought to improve conditions at its Mounds View, Minn., manufacturing plant where its pacemakers are produced. The FDA issued a warning letter about the plant in November 2009 and has not yet declared the problems fully resolved.
Medtronic said it is continuing to work with the agency to satisfy its concerns.
http://www.medicalbillingassistanceinc.com/
Thursday, April 21, 2011
Airport Scanners: Much Ado About Very Little
Airport body scanners pose no significant radiation threat, even to frequent flyers, who are exposed to far more radiation during travel at high altitudes, authors of a review concluded.
The scanners expose people to less than 1% of the radiation associated with cosmic rays at typical flight altitudes. A single exposure to a backscatter x-ray scanner is equivalent to three to nine minutes of radiation encountered in normal daily living.
Nonetheless, deployment of whole-body scanners at airports should not proceed in the absence of definitive studies to determine more precisely the risks and benefits, according to an article published online in Archives of Internal Medicine.
"In medicine, we try to balance risks and benefits of everything we do, and thus while the risks are indeed exceedingly small, the scanners should not be deployed unless they provide benefit-improved national security and safety -- and consideration of these issues is outside the scope of our expertise," Rebecca Smith-Bindman, MD, and Pratik Mehta, of the University of California San Francisco, wrote in conclusion.
"Issues have been raised regarding the efficacy of scanners, and if the scanners are not deemed efficacious, they should not be used."
On Dec. 25, 2009, a Detroit-bound passenger smuggled plastic explosives aboard an airliner, revealing a limitation of current airport screening devices. Since then the Transportation Security Administration has installed almost 500 whole-body scanners at 78 U.S. airports, and twice that many devices are expected to be in operation by the end of 2011, the authors wrote in their introduction.
Two types of scanners are in use. The millimeter-wave scanner emits low-energy waves estimated as a fraction of the energy emitted by a cell phone. The more commonly used backscatter x-ray scanner emits low-dose x-rays, which are absorbed entirely by the most superficial layers of the skin, the authors continued.
Although the detailed images generated by both types of scanners have raised privacy issues, the potential health risks center on the x-ray scanners, which employ ionizing radiation.
But the radiation doses emitted by the scanners are so low that the potential risks are unknown and difficult to quantify, the authors wrote.
Individuals in the U.S. are exposed to an estimated 6.2 millisieverts of ionizing radiation each year, an amount equivalent to 0.1 microsievert (µSv) per minute, according to the National Council on Radiation Protection and Measurements. The two most common sources of radiation are medical procedures and environmental background radiation.
Backscatter whole-body scanners expose individuals to 0.03 to 0.1 µSv per scan, the equivalent of three to nine minutes of radiation from natural sources.
Levels of naturally occurring radiation are increased at higher altitudes, such as those used by airliners. Although the levels change with altitude, radiation exposure during a flight averages about 0.04 µSv per minute of flight time. Thus, backscatter x-ray scanners deliver an amount of radiation equivalent to one to three minutes of flight time.
"Put into context of the entire flight, if a woman embarks on a six-hour flight, she will be exposed to approximately 14.3 µSv of radiation from the flight and 0.03 to 0.1 µSv from passing through the scanner at the airport," the authors wrote. "Thus, the scan will increase her exposure by less than 1%."
Given those calculations, concerns that vulnerable individuals should avoid the scanners are unwarranted, they added.
Offering other common examples for context, Smith-Bindman and Mehta noted that a person would have to pass through an airport scanner 50 times to get the same radiation exposure associated with a single dental x-ray, 1,000 times to equal the exposure of a chest x-ray, 4,000 times to equal the exposure of a mammogram, and 200,000 times to equal the exposure of a single combination abdominal-pelvic CT scan.
Estimating the cancer risk associated with airport scanners is even more difficult than quantifying the exposure, the authors continued.
Risk estimates normally rely on extrapolation from published studies of higher-dose exposures. Such extrapolation from the scanners' exceedingly small radiation doses is questionable and perhaps inappropriate.
Radiation exposure from the scanners is concentrated in the skin. No accepted mathematical models exist for determining the relationship between skin exposure and the risk of skin cancer. Moreover, the distribution of exposure differs from that of the whole-body exposure assumed by available mathematical models.
Noting that 100 million people have a total of 750 million flights per year, Smith-Bindman and Mehta estimated that radiation exposure from airport scanners would cause six excess cancers.
In contrast, 40 million cancers would be expected over the same individuals' lifetimes.
Frequent flyers represent one population potentially vulnerable to radiation exposure from airport scanners. Assuming one million of these passengers take 10 six-hour trips per week for a year, airport scanners would cause four cancers.
That compared with an estimated 600 excess cancers from radiation exposure during the flights and 400,000 cancers over the passengers' lifetimes.
Young children who fly frequently are another potentially vulnerable population. Using a five-year-old girl as an example, the authors estimated that two million girls flying once a week would have one excess breast cancer. In contrast, 250,000 of the girls will develop breast cancer over their lifetimes owing to the 12% lifetime risk of the disease.
"Based on what is known about the scanners, passengers should not fear going through the scans for health reasons, as the risks are truly trivial," the authors wrote in conclusion.
"If individuals feel vulnerable and are worried about the radiation emitted by the scans, they might reconsider flying altogether since most of the small, but real, radiation risk they will receive will come from the flight and not from the exceedingly small exposures from the scans."
http://www.medicalbillingassistanceinc.com/
The scanners expose people to less than 1% of the radiation associated with cosmic rays at typical flight altitudes. A single exposure to a backscatter x-ray scanner is equivalent to three to nine minutes of radiation encountered in normal daily living.
Nonetheless, deployment of whole-body scanners at airports should not proceed in the absence of definitive studies to determine more precisely the risks and benefits, according to an article published online in Archives of Internal Medicine.
"In medicine, we try to balance risks and benefits of everything we do, and thus while the risks are indeed exceedingly small, the scanners should not be deployed unless they provide benefit-improved national security and safety -- and consideration of these issues is outside the scope of our expertise," Rebecca Smith-Bindman, MD, and Pratik Mehta, of the University of California San Francisco, wrote in conclusion.
"Issues have been raised regarding the efficacy of scanners, and if the scanners are not deemed efficacious, they should not be used."
On Dec. 25, 2009, a Detroit-bound passenger smuggled plastic explosives aboard an airliner, revealing a limitation of current airport screening devices. Since then the Transportation Security Administration has installed almost 500 whole-body scanners at 78 U.S. airports, and twice that many devices are expected to be in operation by the end of 2011, the authors wrote in their introduction.
Two types of scanners are in use. The millimeter-wave scanner emits low-energy waves estimated as a fraction of the energy emitted by a cell phone. The more commonly used backscatter x-ray scanner emits low-dose x-rays, which are absorbed entirely by the most superficial layers of the skin, the authors continued.
Although the detailed images generated by both types of scanners have raised privacy issues, the potential health risks center on the x-ray scanners, which employ ionizing radiation.
But the radiation doses emitted by the scanners are so low that the potential risks are unknown and difficult to quantify, the authors wrote.
Individuals in the U.S. are exposed to an estimated 6.2 millisieverts of ionizing radiation each year, an amount equivalent to 0.1 microsievert (µSv) per minute, according to the National Council on Radiation Protection and Measurements. The two most common sources of radiation are medical procedures and environmental background radiation.
Backscatter whole-body scanners expose individuals to 0.03 to 0.1 µSv per scan, the equivalent of three to nine minutes of radiation from natural sources.
Levels of naturally occurring radiation are increased at higher altitudes, such as those used by airliners. Although the levels change with altitude, radiation exposure during a flight averages about 0.04 µSv per minute of flight time. Thus, backscatter x-ray scanners deliver an amount of radiation equivalent to one to three minutes of flight time.
"Put into context of the entire flight, if a woman embarks on a six-hour flight, she will be exposed to approximately 14.3 µSv of radiation from the flight and 0.03 to 0.1 µSv from passing through the scanner at the airport," the authors wrote. "Thus, the scan will increase her exposure by less than 1%."
Given those calculations, concerns that vulnerable individuals should avoid the scanners are unwarranted, they added.
Offering other common examples for context, Smith-Bindman and Mehta noted that a person would have to pass through an airport scanner 50 times to get the same radiation exposure associated with a single dental x-ray, 1,000 times to equal the exposure of a chest x-ray, 4,000 times to equal the exposure of a mammogram, and 200,000 times to equal the exposure of a single combination abdominal-pelvic CT scan.
Estimating the cancer risk associated with airport scanners is even more difficult than quantifying the exposure, the authors continued.
Risk estimates normally rely on extrapolation from published studies of higher-dose exposures. Such extrapolation from the scanners' exceedingly small radiation doses is questionable and perhaps inappropriate.
Radiation exposure from the scanners is concentrated in the skin. No accepted mathematical models exist for determining the relationship between skin exposure and the risk of skin cancer. Moreover, the distribution of exposure differs from that of the whole-body exposure assumed by available mathematical models.
Noting that 100 million people have a total of 750 million flights per year, Smith-Bindman and Mehta estimated that radiation exposure from airport scanners would cause six excess cancers.
In contrast, 40 million cancers would be expected over the same individuals' lifetimes.
Frequent flyers represent one population potentially vulnerable to radiation exposure from airport scanners. Assuming one million of these passengers take 10 six-hour trips per week for a year, airport scanners would cause four cancers.
That compared with an estimated 600 excess cancers from radiation exposure during the flights and 400,000 cancers over the passengers' lifetimes.
Young children who fly frequently are another potentially vulnerable population. Using a five-year-old girl as an example, the authors estimated that two million girls flying once a week would have one excess breast cancer. In contrast, 250,000 of the girls will develop breast cancer over their lifetimes owing to the 12% lifetime risk of the disease.
"Based on what is known about the scanners, passengers should not fear going through the scans for health reasons, as the risks are truly trivial," the authors wrote in conclusion.
"If individuals feel vulnerable and are worried about the radiation emitted by the scans, they might reconsider flying altogether since most of the small, but real, radiation risk they will receive will come from the flight and not from the exceedingly small exposures from the scans."
http://www.medicalbillingassistanceinc.com/
Thursday, April 14, 2011
MRI Volume Loss May Foretell Alzheimer's
Individuals with certain signatures on MRI scans are at greatly increased risk of developing Alzheimer's disease, according to two independent studies.
In one, cognitively normal adults with low cortical thickness parameters characteristic of Alzheimer's disease went on to develop the disease at a 55% rate, compared with 0% among similar people with higher-than-average cortical thickness (P<0.005).
The other study showed that similar MRI-based measurements could predict which patients with mild cognitive impairment would progress to full-blown Alzheimer dementia during the following year, with an odds ratio of 7.2 (P not reported) comparing the highest with the lowest quartiles of cortical volume scores.
The authors of both studies concluded that, in many patients who develop Alzheimer's disease, their brains show physical changes characteristic of the condition long before clinical symptoms qualify them for a diagnosis.
In fact, according to the first study, published online in Neurology, those changes were detectable in apparently healthy people as much as 11 years before diagnosis.
Brad Dickerson, MD, of Massachusetts General Hospital in Boston, and colleagues performed MRI scans in two independent samples of cognitively normal adults in their late 60s and 70s.
The first sample included eight people who went on to receive an Alzheimer's diagnosis a mean of 11.1 years later and 25 whose cognitive performance remained normal. In the second sample, 32 cognitively normal individuals were scanned, including seven who converted to Alzheimer's disease after a mean of 7.1 years.
Ten brain regions were scanned to produce a composite cortical thickness score, measured in millimeters. In both groups, those who went on to develop Alzheimer's disease had scores that were about 0.2 mm lower than participants remaining cognitively normal (P<0.05), Dickerson and colleagues reported.
Also, for each standard deviation of cortical thickness score relative to the mean, the hazard ratio for developing Alzheimer's disease was 3.4 (P<0.0005), the researchers indicated.
The second study was published online in Neuroradiology by Linda McEvoy, PhD, of the University of California San Diego, and colleagues. They performed MRI scans in 203 normal controls, 164 people with mild Alzheimer's disease, and 317 with mild cognitive impairment, all with mean ages of about 75.
As in the study by Dickerson and colleagues, MRI measures of different cortical regions were combined into an overall score. Scores for the cognitively normal and Alzheimer's disease groups were then incorporated into a model applied to the participants with mild cognitive impairment.
In the latter group, nearly 90% had at least 18 months of follow-up. The average one-year rate of conversion to Alzheimer's disease in patients with mild cognitive impairment was 17%.
Among patients in the highest quartile of risk according to the baseline MRI scans, the one-year conversion rate was 40%, versus 3% in the lowest quartile, McEvoy and colleagues reported.
The study also included a second set of MRI scans performed one year after the baseline scans, the researchers indicated. After excluding patients who did not complete a full year of follow-up after the second round of scans or who had converted to Alzheimer's disease during the first year, the analysis covered 170 participants with mild cognitive impairment.
When these results were incorporated into the risk-prediction model, the highest-risk participants with mild cognitive impairment converted to Alzheimer's disease at a one-year rate of 69%, compared with 3% among the lowest-risk participants (odds ratio 12.0, P=0.001).
McEvoy and colleagues acknowledged that predicting which individuals would progress to Alzheimer's disease would have limited clinical value in the absence of treatments that can halt or delay the process.
On the other hand, they wrote, "such predictive prognostic information will be critical if disease-modifying therapies become available."
For their part, Dickerson and colleagues said their findings suggest that MRI markers should be included in research criteria now being developed for so-called preclinical Alzheimer's disease.
Again, although such a designation would have little clinical relevance at present, the research community is eager for a standard, objective definition that could be used to recruit participants for trials of disease-modifying therapies aimed at preventing onset of clinical symptoms.
Both groups of authors indicated that their studies were limited by uncertainties in the baseline characterizations of patients as cognitively normal and in the clinical diagnoses. Additionally, the Neurology study had relatively small sample sizes, whereas McEvoy and colleagues noted that their samples were not representative of the general clinical population.
Also, neither study reported standard diagnostic accuracy measures such as sensitivity, specificity, or positive/negative predictive values for their risk scoring systems.
http://www.mediaclbillingassistanceinc.com/
In one, cognitively normal adults with low cortical thickness parameters characteristic of Alzheimer's disease went on to develop the disease at a 55% rate, compared with 0% among similar people with higher-than-average cortical thickness (P<0.005).
The other study showed that similar MRI-based measurements could predict which patients with mild cognitive impairment would progress to full-blown Alzheimer dementia during the following year, with an odds ratio of 7.2 (P not reported) comparing the highest with the lowest quartiles of cortical volume scores.
The authors of both studies concluded that, in many patients who develop Alzheimer's disease, their brains show physical changes characteristic of the condition long before clinical symptoms qualify them for a diagnosis.
In fact, according to the first study, published online in Neurology, those changes were detectable in apparently healthy people as much as 11 years before diagnosis.
Brad Dickerson, MD, of Massachusetts General Hospital in Boston, and colleagues performed MRI scans in two independent samples of cognitively normal adults in their late 60s and 70s.
The first sample included eight people who went on to receive an Alzheimer's diagnosis a mean of 11.1 years later and 25 whose cognitive performance remained normal. In the second sample, 32 cognitively normal individuals were scanned, including seven who converted to Alzheimer's disease after a mean of 7.1 years.
Ten brain regions were scanned to produce a composite cortical thickness score, measured in millimeters. In both groups, those who went on to develop Alzheimer's disease had scores that were about 0.2 mm lower than participants remaining cognitively normal (P<0.05), Dickerson and colleagues reported.
Also, for each standard deviation of cortical thickness score relative to the mean, the hazard ratio for developing Alzheimer's disease was 3.4 (P<0.0005), the researchers indicated.
The second study was published online in Neuroradiology by Linda McEvoy, PhD, of the University of California San Diego, and colleagues. They performed MRI scans in 203 normal controls, 164 people with mild Alzheimer's disease, and 317 with mild cognitive impairment, all with mean ages of about 75.
As in the study by Dickerson and colleagues, MRI measures of different cortical regions were combined into an overall score. Scores for the cognitively normal and Alzheimer's disease groups were then incorporated into a model applied to the participants with mild cognitive impairment.
In the latter group, nearly 90% had at least 18 months of follow-up. The average one-year rate of conversion to Alzheimer's disease in patients with mild cognitive impairment was 17%.
Among patients in the highest quartile of risk according to the baseline MRI scans, the one-year conversion rate was 40%, versus 3% in the lowest quartile, McEvoy and colleagues reported.
The study also included a second set of MRI scans performed one year after the baseline scans, the researchers indicated. After excluding patients who did not complete a full year of follow-up after the second round of scans or who had converted to Alzheimer's disease during the first year, the analysis covered 170 participants with mild cognitive impairment.
When these results were incorporated into the risk-prediction model, the highest-risk participants with mild cognitive impairment converted to Alzheimer's disease at a one-year rate of 69%, compared with 3% among the lowest-risk participants (odds ratio 12.0, P=0.001).
McEvoy and colleagues acknowledged that predicting which individuals would progress to Alzheimer's disease would have limited clinical value in the absence of treatments that can halt or delay the process.
On the other hand, they wrote, "such predictive prognostic information will be critical if disease-modifying therapies become available."
For their part, Dickerson and colleagues said their findings suggest that MRI markers should be included in research criteria now being developed for so-called preclinical Alzheimer's disease.
Again, although such a designation would have little clinical relevance at present, the research community is eager for a standard, objective definition that could be used to recruit participants for trials of disease-modifying therapies aimed at preventing onset of clinical symptoms.
Both groups of authors indicated that their studies were limited by uncertainties in the baseline characterizations of patients as cognitively normal and in the clinical diagnoses. Additionally, the Neurology study had relatively small sample sizes, whereas McEvoy and colleagues noted that their samples were not representative of the general clinical population.
Also, neither study reported standard diagnostic accuracy measures such as sensitivity, specificity, or positive/negative predictive values for their risk scoring systems.
http://www.mediaclbillingassistanceinc.com/
Saturday, April 9, 2011
MRI value in cardiac arrest
In the past year, three studies have been published evaluating the use of magnetic resonance imaging (MRI) to determine the prognosis of patients suffering out-of-hospital cardiac arrest, a leading cause of death in developed countries [1-3]. The initial survival of these patients has improved recently thanks to the increased availability of automated defibrillators and induced hypothermia [4,5], leading to an increasing number of patients hospitalized with post-anoxic coma. However, survival rates without major neurological sequelae remain low, and intensive care must be withdrawn in a significant number of patients who will otherwise evolve to a vegetative or minimally conscious state. This decision is currently based on clinical data. Lack of motor response at 24 and 72 hours, absent corneal reflex and pupillary response at 24 hours have been shown to be indicative of poor clinical outcome [6]. This approach, however, has many limitations. While it can reliably predict a poor clinical outcome, prediction of good clinical evolution is still difficult. Among patients with a good clinical outcome, it is impossible to separate those who will have a complete recovery (restitutio ad integrum) from those whose quality of life will be hampered by significant neurological sequelae. Clinical examination can provide variable results and is not compatible with the deep sedation required by some therapeutic protocols, especially hypothermia.
MRI is now widely available, and, with some precautions, can be performed in patients under mechanical ventilation. Despite the fact that MRI with diffusion-weighted imaging (DWI) has been shown to efficiently detect anoxo-ischemic brain injury (especially in stroke), its application for the evaluation of cardiac arrest patients had not been developed until very recently. Three recent papers attempt to address this issue.
In Critical Care, Choi and colleagues [1] have shown in a series of 39 survivors of cardiac arrest that the presence of lesions in both the cortex and basal ganglia on DWI was strongly associated with a poor outcome. Moreover, they could determine cut-off values of the apparent diffusion coefficient (ADC; quantitative data that can be extracted from the DWI sequence) that could predict this outcome with 100% specificity. Clinical decisions can thus be made based on both reliable quantitative information and images that are useful for explaining the situation to the patient's family. Wijman and colleagues [2] have shown that brain volume with ADC values below certain thresholds correlated with clinical outcome with a better sensitivity than clinical examination. A study by Wu and colleagues [3] basically combined these two approaches and found similar results.
While promising, these three studies share some limitations. They all included a limited number of patients. Due to the rapid time-dependant variations of ADC, MRI can only be performed early (2 to 5 days) after the cardiac arrest, during a period when performing this examination is potentially associated with a significant risk, since patients might still require catecholamine. Cut-off values can predict a poor outcome with perfect specificity but less than perfect sensitivity, meaning that, as with clinical examination, while the presence of lesions with a reduced ADC beyond a defined threshold is strongly suggestive of a poor outcome, a significant number of subjects with a 'good' MRI will also still have a poor outcome. They also share the risk that, if the clinicians were not fully blinded to the result of the MRI, some clinical decisions could have been based on the results of the scan, leading to so-called 'self-fulfilling prophecies'. Finally, all these studies were monocentric. While ADC was initially supposed to be a physical characteristic of the tissue, significant variations in its measurement have been reported, depending on the MRI device [7]. These results must thus be confirmed and improved in a multicentric study designed to correct machine dependant variations. If such a study should be performed, introduction of other MRI parameters, such as fractional anisotropy and spectroscopy, might certainly be relevant.
Sunday, April 3, 2011
MRI Market will continue to expand
The expanison of MRI usage and demand continue to increase as is seen by the following:
Due to its high spatial resolution and excellent tissue contrast, magnetic resonance imaging (MRI) has become the most commonly used imaging method to evaluate joints. Most musculoskeletal MRI is performed using 2D fast spin–echo sequences.
MRI is rapidly becoming the diagnostic tool of choice by physcians and also for the continued well-being and comfort of patients. Now, the field expands into Veterinarian industry as well. This allows for MRI centers to be more innovative with their inventory of scans, especially in rural provider areas.
Virginia Tech's Marion duPont Scott Equine Medical Center (EMC) has announced that they are now able to offer high field MRI service for horses. A mobile high field MRI is scheduled to the clinic in Leesburg, Va., about once a month, according to a report on the EMC website. The high field MRI will be offered in addition to the low field MRI already offered by the clinic.
High field MRIs provide veterinarians with a higher resolution image needed to diagnose certain problems. Unlike low field MRIs that are performed in a standing horse, general anesthesia is required for high field MRIs to aid in capturing the higher quality image. Additionally, high field MRIs provide the opportunity for examining areas that are difficult (or impossible) to image in a standing horse, such as the upper portions of the limbs.
High field MRIs at the EMC will be performed on an outpatient basis, and the total cost for the procedure is around $2,400.
Unique MRI solution providers such as Medical Billing Assistance, Inc (MDBL:OTCQB/BB) will continue to lead the field in growth opportunites due to the provision of innovative solutions for MRI inventory progression and billing modifications both of which are designed to increase profitability for MRI centers.
http://www.medicalbillingassistanceinc.com/
Due to its high spatial resolution and excellent tissue contrast, magnetic resonance imaging (MRI) has become the most commonly used imaging method to evaluate joints. Most musculoskeletal MRI is performed using 2D fast spin–echo sequences.
MRI is rapidly becoming the diagnostic tool of choice by physcians and also for the continued well-being and comfort of patients. Now, the field expands into Veterinarian industry as well. This allows for MRI centers to be more innovative with their inventory of scans, especially in rural provider areas.
Virginia Tech's Marion duPont Scott Equine Medical Center (EMC) has announced that they are now able to offer high field MRI service for horses. A mobile high field MRI is scheduled to the clinic in Leesburg, Va., about once a month, according to a report on the EMC website. The high field MRI will be offered in addition to the low field MRI already offered by the clinic.
High field MRIs provide veterinarians with a higher resolution image needed to diagnose certain problems. Unlike low field MRIs that are performed in a standing horse, general anesthesia is required for high field MRIs to aid in capturing the higher quality image. Additionally, high field MRIs provide the opportunity for examining areas that are difficult (or impossible) to image in a standing horse, such as the upper portions of the limbs.
High field MRIs at the EMC will be performed on an outpatient basis, and the total cost for the procedure is around $2,400.
Unique MRI solution providers such as Medical Billing Assistance, Inc (MDBL:OTCQB/BB) will continue to lead the field in growth opportunites due to the provision of innovative solutions for MRI inventory progression and billing modifications both of which are designed to increase profitability for MRI centers.
http://www.medicalbillingassistanceinc.com/
Monday, March 28, 2011
MRI advances in Breast Screening Technology
While the mammogram is still considered the gold standard for breast screening, those who need additional imaging have new options. Currently, MRI is the traditional next step for the about 30 percent of women with dense breasts, those with positive BRCA1/BRCA2 mutations, and women with suspicious lesions. The times, they are a-changing, though, with recent advances in breast imaging technology. Not all women can undergo an MRI, and it’s a more expensive and time-consuming study to read than newer modalities.
Enter nuclear breast imaging, the catch-all phrase for several modalities that use a radiopharmaceutical agent in scanning, including gamma imaging and positron emission mammography (PEM). Known as both molecular breast imaging (MBI) and breast-specific gamma imaging (BSGI), the gamma cameras are an adjunctive technology for suspicious lesions found during mammogram. Physicians are also using it in place of MRI for women who are unable to tolerate that study or have metallic implants.
Many use the terms MBI and BSGI interchangeably, however the machines use different technology. BSGI uses a sodium iodide scintillator technology developed by Dilon Technologies (the only company developing such a technology), and MBI uses cadmium-zinc-telluride digital detectors developed by the Mayo Clinic.
“We have been using breast-specific gamma imaging since 2007, primarily for high risk individuals with difficult mammograms and/or sonograms, dense breasts, and for the evaluation of asymmetric densities,” said Barbara Ward, MD, a partner in Weinstein Imaging Associates in Pittsburgh, Pa.
“One of the most helpful and important uses of this modality is for patients who present with a palpable abnormality with a negative mammogram and ultrasound,” she said. “If the subsequent BSGI is negative, the patient has been very reassured. On the other hand, we have picked up some cancers that were both mammographically and sonographically occult with BSGI.”
Gamma Imaging
The Dilon 6800 is the machine currently used by those performing BSGI studies. This technology detects Tc-99m sestamibi uptake, with a single-head gamma camera. It can typically detect lesions as small as 3 mm in diameter.
Researchers at the Mayo Clinic developed a dual-head gamma camera which also detects Tc-99m sestamibi uptake in suspicious breast lesions. Gamma Medica licensed the technology and recently introduced it commercially as the LumaGEM MBI System, which can reportedly detect lesions 1.6 mm in size, while using less radiation exposure. This is important because the major concern with BSGI is that “it’s about 25 times the radiation dose of a mammogram,” according to Emily Crane, research director and co-author of KLAS Breast Imaging 2010: A More Complete Picture, an independent healthcare vendor performance report released in December.
The Gamma Medica product is so new that KLAS researchers were unable interview any sites using the technology on a non-research basis.
While MBI is not used as a primary screening tool, its use as an adjunctive modality has shown efficacy. A study from the Mayo Clinic, published in the January 2011 issue of Radiology, compared MBI to mammography in 936 at-risk women. The authors found that sensitivity for mammography alone was 27 percent, while MBI and mammography combined had a sensitivity of 91 percent. In that study, 11 cancer diagnoses were made. MBI alone detected seven of the tumors, while one was detected by mammography alone, one by both techniques combined, and one by neither.
“MRI of the breast is very sensitive and a lot of lesions get picked up,” said Ravipati. “We have to sort out what is important, what is not. MBI is cheaper, more accurate, easy to use, and more definitive.”
http://www.medicalbillingassistanceinc.com/
Enter nuclear breast imaging, the catch-all phrase for several modalities that use a radiopharmaceutical agent in scanning, including gamma imaging and positron emission mammography (PEM). Known as both molecular breast imaging (MBI) and breast-specific gamma imaging (BSGI), the gamma cameras are an adjunctive technology for suspicious lesions found during mammogram. Physicians are also using it in place of MRI for women who are unable to tolerate that study or have metallic implants.
Many use the terms MBI and BSGI interchangeably, however the machines use different technology. BSGI uses a sodium iodide scintillator technology developed by Dilon Technologies (the only company developing such a technology), and MBI uses cadmium-zinc-telluride digital detectors developed by the Mayo Clinic.
“We have been using breast-specific gamma imaging since 2007, primarily for high risk individuals with difficult mammograms and/or sonograms, dense breasts, and for the evaluation of asymmetric densities,” said Barbara Ward, MD, a partner in Weinstein Imaging Associates in Pittsburgh, Pa.
“One of the most helpful and important uses of this modality is for patients who present with a palpable abnormality with a negative mammogram and ultrasound,” she said. “If the subsequent BSGI is negative, the patient has been very reassured. On the other hand, we have picked up some cancers that were both mammographically and sonographically occult with BSGI.”
Gamma Imaging
The Dilon 6800 is the machine currently used by those performing BSGI studies. This technology detects Tc-99m sestamibi uptake, with a single-head gamma camera. It can typically detect lesions as small as 3 mm in diameter.
Researchers at the Mayo Clinic developed a dual-head gamma camera which also detects Tc-99m sestamibi uptake in suspicious breast lesions. Gamma Medica licensed the technology and recently introduced it commercially as the LumaGEM MBI System, which can reportedly detect lesions 1.6 mm in size, while using less radiation exposure. This is important because the major concern with BSGI is that “it’s about 25 times the radiation dose of a mammogram,” according to Emily Crane, research director and co-author of KLAS Breast Imaging 2010: A More Complete Picture, an independent healthcare vendor performance report released in December.
The Gamma Medica product is so new that KLAS researchers were unable interview any sites using the technology on a non-research basis.
While MBI is not used as a primary screening tool, its use as an adjunctive modality has shown efficacy. A study from the Mayo Clinic, published in the January 2011 issue of Radiology, compared MBI to mammography in 936 at-risk women. The authors found that sensitivity for mammography alone was 27 percent, while MBI and mammography combined had a sensitivity of 91 percent. In that study, 11 cancer diagnoses were made. MBI alone detected seven of the tumors, while one was detected by mammography alone, one by both techniques combined, and one by neither.
“MRI of the breast is very sensitive and a lot of lesions get picked up,” said Ravipati. “We have to sort out what is important, what is not. MBI is cheaper, more accurate, easy to use, and more definitive.”
http://www.medicalbillingassistanceinc.com/
Saturday, March 26, 2011
Global Spending medical imaging exceeds $21B in 2010
TriMarkPublications.com cites in its newly published "Medical Imaging Markets" report that global spending on medical imaging equipment exceeded $21 billion in 2010. For more information, visit: http://www.trimarkpublications.com/products/Medical-Imaging-Markets.html.
Medical imaging can be categorized into nine main modalities: X-ray, ultrasound, computed tomography (CT), positron emission tomography (PET), single photon emission computed tomography (SPECT), magnetic resonance imaging (MRI), nuclear medicine, mammography and fluoroscopy. Globally, X-ray is the most used imaging procedure with about 108 million X-ray exams per year. MRI is second with 26 million examinations per year. PET, SPECT, CT and nuclear medicine rank third with 30 million examinations per year. Picture archiving and communication systems (PACS) and contrast agents are the sub-segments in medical imaging market that have gained significant growth in recent years. As such, the global medical imaging industry is primed to experience significant expansion throughout the decade.
The "Medical Imaging Markets" report covers: Computed Tomography (CT) Magnetic Resonance Imaging (MRI) Positron Emission Tomography (PET) Single-Photon Emission Computed Tomography (SPECT) Hybrid Modalities Mammography Digital Radiography/Computed Radiography (DR/CR) Image-Guided Radiation Therapy (IGRT) Cardiac CT Imaging CT Angiography Nuclear Medicine in Cardiac Imaging MRI vs. SPECT in Cardiac Procedures Echocardiography in Cardiac Imaging Optical Coherence Tomography (OCT)
The "Medical Imaging Markets" report examines companies manufacturing medical imaging equipment and supplies in the world. Companies covered include: 3mensio Medical, Agfa HealthCare, Analogic, Ardent Sound, Avreo, Biosound Esaote, BK Medical, BRIT Systems, Canon, Focus Surgery, Fonar, Fujifilm, Fukuda Denshi, GE Healthcare, Hitachi Medical, Hologic, InfiMed, Intelerad, Konica Minolta, Lantheus, Lumedx, Median, Medis, Medison, Medtronic, NanoScan, NovaRad, Phantom Laboratory, Philips Healthcare, Sectra Medical, Schick Technologies, ScImage, Siemens Healthcare, Shimadzu, SonoSite, Spacelabs Healthcare, Syntermed, TeraMedica, TeraRecon, TomTec Imaging, Toshiba, UltraRAD, Varian, Vepro, Vidar Systems, Vital Images, VuCOMP and Xoran.
Detailed charts with sales forecasts and marketshare data are included. For more information, visit: http://www.trimarkpublications.com/products/Medical-Imaging-Markets.html
Wednesday, March 23, 2011
MRI usage continues to increase
Hospital emergency departments have been ordering CT and MRI scans for an increasing percentage of injured patients without any corresponding change in the patient mix that would justify the more expensive imaging, researchers said.
In 2007, 15% of imaging in emergency departments was performed with CT or MRI for injury-related conditions, up from just 6% in 1998 (P<0.001 for trend), according to Frederick Kofi Korley, MD, of Johns Hopkins University, and colleagues.
During that a period of time, the prevalence of life-threatening conditions among emergency patients changed little, they reported in the Oct. 6 issue of the Journal of the American Medical Association.
The researchers stopped short of saying the advanced technologies were being used needlessly. But they called for a hard look at why CT or MRI is increasingly chosen in emergency departments.
"Further work is needed to understand the patient, hospital, and physician factors responsible for this increase and to optimize the risk-benefit balance of advanced radiology use," Korley and colleagues wrote.
Their conclusions were based on data from the CDC's National Hospital Ambulatory Medical Care Survey, which collects information on outpatient (including emergency department) visits at a nationwide sample of 370 nonfederal hospitals.
The data covered 5,237 emergency department visits for injury-related conditions in 1998 and 6,567 in 2007. Over this span, the proportion of visits involving life-threatening conditions increased from 1.7% to 2% (P=0.04 for trend). The fractions resulting in inpatient admission or ICU treatment did not change significantly, Korley and colleagues found.
Use of CT or MRI increased markedly over the same period, after adjusting for potential confounding variables including age, insurance status, pain severity, and the immediacy of when patients should be seen.
Korley and colleagues calculated that the odds ratio of receiving a CT or MRI scan in an emergency department in 2007 versus 1998 was 3.43 (95% CI 2.71 to 4.35).
They also identified certain factors associated significantly with greater likelihood of CT or MRI use (adjusted for confounders):
Notably lacking from this list was insurance status. The odds ratio for advanced imaging for uninsured patients versus those with some form of insurance was 0.94 (95% CI 0.84 to 1.06).
The researchers also determined that, in 2008, patients undergoing CT or MRI scans remained in the emergency department far longer than patients not having such imaging.
Mean visit duration for patients having advanced imaging was 5 hours and 14 minutes (95% CI 297 to 331) compared with 3 hours and 10 minutes (95% CI 180 to 201) for other patients. But these values were not adjusted for severity of injury or other factors potentially accompanying a need for CT or MRI scans that might complicate a case.
Although Korley and colleagues had no data on the reasons for ordering CT or MRI scans rather than conventional x-rays for individual cases, they still found their findings to be worrisome.
"CT scans are more sensitive for detecting serious injuries, but monetary and nonmonetary costs are associated with their use," they wrote.
Nonmonetary costs include health risks, such as the increased radiation exposure relative to conventional x-rays as well as reactions and other adverse effects related to contrast agents. The latter are also an issue with MRI.
On the other hand, Korley and colleagues acknowledged that CT and MRI are simply better than conventional x-rays for diagnosing certain injuries, such as cervical spine fractures.
Other factors that may promote their use include fear of litigation for missed diagnoses, direct-to-consumer advertising, the increased prevalence of CT and MRI machines in or near emergency departments, and advances in the equipment that make it easier to use, the researchers indicated.
"The role of evidence-adoption strategies such as computerized decision support and audit and feedback in promoting adherence to decision rules for imaging needs to be further understood," they concluded.
They noted several limitations to the study, including the absence of detail on injury nature and severity, the lack of data on incidental findings that might have improved patients' overall outcomes, and the database's reliance on retrospective chart review.
In 2007, 15% of imaging in emergency departments was performed with CT or MRI for injury-related conditions, up from just 6% in 1998 (P<0.001 for trend), according to Frederick Kofi Korley, MD, of Johns Hopkins University, and colleagues.
During that a period of time, the prevalence of life-threatening conditions among emergency patients changed little, they reported in the Oct. 6 issue of the Journal of the American Medical Association.
The researchers stopped short of saying the advanced technologies were being used needlessly. But they called for a hard look at why CT or MRI is increasingly chosen in emergency departments.
"Further work is needed to understand the patient, hospital, and physician factors responsible for this increase and to optimize the risk-benefit balance of advanced radiology use," Korley and colleagues wrote.
Their conclusions were based on data from the CDC's National Hospital Ambulatory Medical Care Survey, which collects information on outpatient (including emergency department) visits at a nationwide sample of 370 nonfederal hospitals.
The data covered 5,237 emergency department visits for injury-related conditions in 1998 and 6,567 in 2007. Over this span, the proportion of visits involving life-threatening conditions increased from 1.7% to 2% (P=0.04 for trend). The fractions resulting in inpatient admission or ICU treatment did not change significantly, Korley and colleagues found.
Use of CT or MRI increased markedly over the same period, after adjusting for potential confounding variables including age, insurance status, pain severity, and the immediacy of when patients should be seen.
Korley and colleagues calculated that the odds ratio of receiving a CT or MRI scan in an emergency department in 2007 versus 1998 was 3.43 (95% CI 2.71 to 4.35).
They also identified certain factors associated significantly with greater likelihood of CT or MRI use (adjusted for confounders):
- Severe pain, OR 1.41 (95% CI 1.21 to 1.64) versus mild pain
- Moderate pain, OR 1.26 (95% CI 1.07 to 1.48) versus mild pain
- Teaching hospital, OR 1.52 (95% CI 1.22 to 1.90) versus nonteaching
- Age at least 60, OR 2.57 (95% CI 2.27 to 2.91) versus ages 18 to 45
- Should be seen in less than 15 minutes, OR 2.06 (95% CI 1.80 to 2.36) versus should be seen in 15 to 60 minutes
Notably lacking from this list was insurance status. The odds ratio for advanced imaging for uninsured patients versus those with some form of insurance was 0.94 (95% CI 0.84 to 1.06).
The researchers also determined that, in 2008, patients undergoing CT or MRI scans remained in the emergency department far longer than patients not having such imaging.
Mean visit duration for patients having advanced imaging was 5 hours and 14 minutes (95% CI 297 to 331) compared with 3 hours and 10 minutes (95% CI 180 to 201) for other patients. But these values were not adjusted for severity of injury or other factors potentially accompanying a need for CT or MRI scans that might complicate a case.
Although Korley and colleagues had no data on the reasons for ordering CT or MRI scans rather than conventional x-rays for individual cases, they still found their findings to be worrisome.
"CT scans are more sensitive for detecting serious injuries, but monetary and nonmonetary costs are associated with their use," they wrote.
Nonmonetary costs include health risks, such as the increased radiation exposure relative to conventional x-rays as well as reactions and other adverse effects related to contrast agents. The latter are also an issue with MRI.
On the other hand, Korley and colleagues acknowledged that CT and MRI are simply better than conventional x-rays for diagnosing certain injuries, such as cervical spine fractures.
Other factors that may promote their use include fear of litigation for missed diagnoses, direct-to-consumer advertising, the increased prevalence of CT and MRI machines in or near emergency departments, and advances in the equipment that make it easier to use, the researchers indicated.
"The role of evidence-adoption strategies such as computerized decision support and audit and feedback in promoting adherence to decision rules for imaging needs to be further understood," they concluded.
They noted several limitations to the study, including the absence of detail on injury nature and severity, the lack of data on incidental findings that might have improved patients' overall outcomes, and the database's reliance on retrospective chart review.
Friday, March 18, 2011
CEO Focus: Overview of MRI Market
CEO Focus: Overview of MRI Market: "In a study done in 2008 the MRI market was projected to reach $5.5 billion through 2010. Those numbers will soon be available. Lets look at ..."
Overview of MRI Market
In a study done in 2008 the MRI market was projected to reach $5.5 billion through 2010. Those numbers will soon be available. Lets look at some of these factors in the MRI market place. MRI represents the fastest growing segment, as hospitals and clinics upgrade old equipment with state-of-the-art systems, according to a report by Global Industry Analysts (GIA).
Since the introduction of magnetic resonance imaging (MRI), the technology has become a ubiquitous diagnostic tool for better understanding of diseases. A trade-off between patient-comfort designs and enhanced diagnostic information highlights the trend in modern MRI equipment research. In this highly sophisticated industry, innovation and service quality are the trump cards of success. Image quality remains the impulse for equipment selection. Field strength is a standard component of image quality as it adds to extended application range, signal-to-noise ratio and short examination times. Use of dedicated MRI systems is expected to witness significant growth due to high imaging quality and cost effectiveness.
Development of 3T scanners has provided the MRI industry an edge over 1.5T scanners, much touted as the industry's gold standard. 3T MRI systems are a success story in the MRI market today. Lower examination costs complimented by improved image quality and lesser scan times highlight the pros of 3T scanners.
Japan represents the second largest market for MRI equipment. The country holds the distinction of featuring the highest MRI scanners per million population.
MRI industry is in its infancy in most regions of Asia-Pacific, and countries such as India, Singapore, Malaysia, Thailand, South Korea, China offering enormous potential for growth. Asia-Pacific is projected to register a CAGR of 11.6% over the period, 2005-2010. Open MRI systems market in Asia-Pacific is estimated at $81 million through 2008.
GE Healthcare, Siemens Medical Solutions and Philips Medical Systems dominate the global MRI equipment market. Other prominent players profiled in the report include Esaote SPA, Fonar Corp., Hitachi Medical Corp., IMRIS, Medinus, Medtronic Surgical Navigation Technologies and Toshiba Medical Systems Corp.
Since the introduction of magnetic resonance imaging (MRI), the technology has become a ubiquitous diagnostic tool for better understanding of diseases. A trade-off between patient-comfort designs and enhanced diagnostic information highlights the trend in modern MRI equipment research. In this highly sophisticated industry, innovation and service quality are the trump cards of success. Image quality remains the impulse for equipment selection. Field strength is a standard component of image quality as it adds to extended application range, signal-to-noise ratio and short examination times. Use of dedicated MRI systems is expected to witness significant growth due to high imaging quality and cost effectiveness.
Development of 3T scanners has provided the MRI industry an edge over 1.5T scanners, much touted as the industry's gold standard. 3T MRI systems are a success story in the MRI market today. Lower examination costs complimented by improved image quality and lesser scan times highlight the pros of 3T scanners.
Japan represents the second largest market for MRI equipment. The country holds the distinction of featuring the highest MRI scanners per million population.
MRI industry is in its infancy in most regions of Asia-Pacific, and countries such as India, Singapore, Malaysia, Thailand, South Korea, China offering enormous potential for growth. Asia-Pacific is projected to register a CAGR of 11.6% over the period, 2005-2010. Open MRI systems market in Asia-Pacific is estimated at $81 million through 2008.
GE Healthcare, Siemens Medical Solutions and Philips Medical Systems dominate the global MRI equipment market. Other prominent players profiled in the report include Esaote SPA, Fonar Corp., Hitachi Medical Corp., IMRIS, Medinus, Medtronic Surgical Navigation Technologies and Toshiba Medical Systems Corp.
Monday, March 14, 2011
The ABC's of MRI
Magnetic Resonance Imaging
Information for Patients*
-What is magnetic resonance imaging (MRI)?
-What is MRI used for?
-Is MRI safe?
-How to prepare for the MRI examination.
-What is the MRI examination like?
What is magnetic resonance imaging (MRI)?
MRI, or magnetic resonance imaging, is a means of "seeing" inside of the body in order for doctors to find certain diseases or abnormal conditions. MRI does not rely on the type of radiation (i.e., ionizing radiation) used for an x-ray or computed tomography (CT) scan. The MRI examination requires specialized equipment that uses a powerful, constant magnetic field, rapidly changing local magnetic fields, radiofrequency energy, and dedicated equipment including a powerful computer to create very clear pictures of internal body structures.
During the MRI examination, the patient is placed within the MR system or scanner. The powerful, constant magnetic field aligns a tiny fraction of subatomic particles called protons that are present in most of the body's tissues. Radiofrequency energy is applied to cause these protons to produce signals that are picked up by a receiver within the scanner. The signals are specially characterized using the rapidly changing, local magnetic field and computer-processed to produce images of the body part of interest.
What is MRI used for?
MRI has become the preferred procedure for diagnosing a large number of potential problems in many different parts of the body. In general, MRI creates pictures that can show differences between healthy and unhealthy tissue. Doctors use MRI to examine the brain, spine, joints (e.g., knee, shoulder, wrist, and ankle), abdomen, pelvic region, breast, blood vessels, heart and other body parts.
Is MRI safe?
To date, over 200 million patients have had MRI examinations. Every year, approximately 10 million patients undergo MRI procedures. MRI has been shown to be extremely safe as long as proper safety precautions are taken. In general, the MRI procedure produces no pain and causes no known short-term or long-term tissue damage of any kind.
The powerful magnetic field of the scanner can attract certain metallic objects known as 'ferromagnetic' objects, causing them to move suddenly and with great force towards the center of the MR system. This may pose a risk to the patient or anyone in the way of the object. Therefore, great care is taken to prevent ferromagnetic objects from entering the MR system room. It is vital that you remove metallic objects in advance of an MRI exam, including watches, jewelry, and items of clothing that have metallic threads or fasteners.
MRI facilities have screening procedures that, when carefully followed, will ensure that the MRI technologist and radiologist knows about the presence of metallic implants and materials so that special precautions can be taken (see below). In some unusual cases the examination may be canceled because of concern related to a particular implant or device. For example, if an MRI is ordered, it may be canceled if the patient has a ferromagnetic aneurysm clip because of the risk dislodging the clip from the blood vessel. Also, the magnetic field of the scanner can damage an external hearing aid or cause a heart pacemaker to malfunction. If you have a bullet or other metallic fragment in your body there is a potential risk that it could change position, possibly causing injury.
Information for Patients*
-What is magnetic resonance imaging (MRI)?
-What is MRI used for?
-Is MRI safe?
-How to prepare for the MRI examination.
-What is the MRI examination like?
What is magnetic resonance imaging (MRI)?
MRI, or magnetic resonance imaging, is a means of "seeing" inside of the body in order for doctors to find certain diseases or abnormal conditions. MRI does not rely on the type of radiation (i.e., ionizing radiation) used for an x-ray or computed tomography (CT) scan. The MRI examination requires specialized equipment that uses a powerful, constant magnetic field, rapidly changing local magnetic fields, radiofrequency energy, and dedicated equipment including a powerful computer to create very clear pictures of internal body structures.
During the MRI examination, the patient is placed within the MR system or scanner. The powerful, constant magnetic field aligns a tiny fraction of subatomic particles called protons that are present in most of the body's tissues. Radiofrequency energy is applied to cause these protons to produce signals that are picked up by a receiver within the scanner. The signals are specially characterized using the rapidly changing, local magnetic field and computer-processed to produce images of the body part of interest.
What is MRI used for?
MRI has become the preferred procedure for diagnosing a large number of potential problems in many different parts of the body. In general, MRI creates pictures that can show differences between healthy and unhealthy tissue. Doctors use MRI to examine the brain, spine, joints (e.g., knee, shoulder, wrist, and ankle), abdomen, pelvic region, breast, blood vessels, heart and other body parts.
Is MRI safe?
To date, over 200 million patients have had MRI examinations. Every year, approximately 10 million patients undergo MRI procedures. MRI has been shown to be extremely safe as long as proper safety precautions are taken. In general, the MRI procedure produces no pain and causes no known short-term or long-term tissue damage of any kind.
The powerful magnetic field of the scanner can attract certain metallic objects known as 'ferromagnetic' objects, causing them to move suddenly and with great force towards the center of the MR system. This may pose a risk to the patient or anyone in the way of the object. Therefore, great care is taken to prevent ferromagnetic objects from entering the MR system room. It is vital that you remove metallic objects in advance of an MRI exam, including watches, jewelry, and items of clothing that have metallic threads or fasteners.
MRI facilities have screening procedures that, when carefully followed, will ensure that the MRI technologist and radiologist knows about the presence of metallic implants and materials so that special precautions can be taken (see below). In some unusual cases the examination may be canceled because of concern related to a particular implant or device. For example, if an MRI is ordered, it may be canceled if the patient has a ferromagnetic aneurysm clip because of the risk dislodging the clip from the blood vessel. Also, the magnetic field of the scanner can damage an external hearing aid or cause a heart pacemaker to malfunction. If you have a bullet or other metallic fragment in your body there is a potential risk that it could change position, possibly causing injury.
Friday, March 11, 2011
Stark Law presents opportunity
Lets first identify what the Stark Law is and then briefly discuss the opportunities it creates
Physician Self-Referral Regulations commonly referred to as the Stark Law:
Section 1877 of the Social Security Act (42 U.S.C. 1395nn) prohibits physicians from referring Medicare patients for certain designated health services (DHS) to an entity with which the physician or a member of the physician's immediate family has a financial relationship unless an exception applies. It also prohibits an entity from presenting or causing to be presented a bill or claim to anyone for DHS furnished as a result of a prohibited referral.In addition, section 1903(s) (42 U.S.C. 1396b) of the Social Security Act extends this referral prohibition to the Medicaid program.
The physician self-referral law can be found in section 1877 of the Social Security Act (42 U.S.C. 1395nn). The regulations are located in Title 42 of the Code of Federal Regulations §411.350 – §411.389.
As this pertains to the MRI industry, the regulatory issues create opportunities for consolidation of the practices that are inhibited through the Stark Law regulations. Changes specifically applied by the recent Health Act enacted by the Obama Administration are as follows:
Change to Stark In-Office Ancillary Services Exception
The recent Change to Stark In-Office Ancillary Services Exception
The recent health care reform legislation included one somewhat significant change to the Stark In-Office Ancillary Services Exception. As you will recall, this exception permits the referral source physicians who are members of a physician group practice to refer a patient for imaging services (or other Designated Health Services - DHS) to be provided within the group practice without violating Stark. This exception is basically what permits physician group practices to own and operate and receive compensation for imaging services and other DHS provided within their group practice.
Effective immediately upon the legislation being signed by Obama (March 23, 2010), a physician within a group practice referring his/her patient for MRI, CT or PET to be provided within the group practice must provide the patient, at the time of the referral, written notice that the patient may obtain these imaging services from a supplier other than the group practice. The written notice must provide the patient with a list of such alternative suppliers in the area where the patient resides.
At the present time, this new requirement only applies to DHS in the form of MRI, CT and PET. And it only applies to physician group practices composed of physician referral sources."
More competition and less totally self directed practices. Next level of clear opportunity is in the under-served identified rural areas.
Diagnostic imaging providers should consider the following when applying the new definition of DHS entity:
- Unlike referring physicians (e.g., cardiologists), radiologists will generally be permitted to have an ownership in such under arrangements joint ventures because they typically are not considered referring physicians under Stark. Thus, under the above CT under arrangements example, if the CT service provider is owned by non-radiologists, then the arrangement will not be viable under the Final Rule if the physician owners refer to the hospital for CT services. By contrast, however, if the entity were owned by radiologists, this arrangement could remain in effect in compliance with Stark.
- In practice, the only available ownership exception (for referring physicians) that will protect an under arrangements service provider is the rural provider exception. Therefore, unless substantially all of the patients reside in a rural area, under arrangements service agreements with referring physicians will be prohibited.
- Although an arrangement limited solely to discrete components of the service (e.g., equipment, supplies, non-physician personnel), by itself, will not rise to the level of �performing� the service, it is not clear, whether an entity that performs some, but not substantially all, of the clinical aspects of the service (e.g., turnkey management service provider) will be considered to be performing DHS.
The initiation of service provisions for MRI's in rural areas is a wide open uncontested field at this point in time. An innovative solution that provides cost effective MRI services with a turnkey approach will both positively impact the market place and help physicians better serve their patients. This professional approach will enable physicians to create alternative stream of revenue while also providing increased wellness and preventive care in their practices.
Monday, March 7, 2011
MRI Industry
Industry Trends:
The full universe of the medical imaging industry (MRI, MRA, PET, CAT, X-Ray) generates upwards towards $100 Billion annually. Industry trade groups such as America Health Insurance Plans expect this market to double in the next five years.
There are several catalysts for this explosive growth. These contributing factors are:
Ø An aging population demanding more medical services (baby boomer effect)
Ø Potential increased demand of over 30 million more people added to insurance rolls by recent Health Care Legislation
Ø MRI imaging has become a benchmark standard for medical diagnosis
Ø Open Air MRI systems have become the preferred choice by both physicians and patients, handling over 50% of all types of scans in marketplace
Ø Open Air MRI systems offer advantages of lower purchase and operational costs while offering exceptional quality for patient experience.
The industry offers great opportunity due to 3 major factors: Regulatory change, Reimbursement models, and Consolidation potential.Increased demand will come as the diagnostic tool of choice for Physicians has increasing become the MRI. Radiation exposure has become a health related issue for the imaging industry as a whole, it is therefore more attractive to have patients use the MRI as a diagnostic tool. The many causitive factors that will generate increased demand for MRI's will explode the growth opportunity in this sector.
Due to increased regulatory requirements, increasing costs with lower profitability and other issues facing the industry, the need for innovative solutions has never been greater. The opportunities in this sector will exponentially increase for those who provide these innovative solutions. The fragmented nature of the industry opens the doors for exceptional consolidation opportunities and the effectiveness of these consolidations in rural areas offer an even greater opportunity.
Investors need to search for innovative and forward thinking companies who are providing fast growth alternatives in this vastly growing market. The same old way of doing business in the imaging industry is rapidly fading and the remains find huge players who are heavily debt ladened and stuck with aging technology. The new model will be sleek and fast and able to move quickly with little to no debt while providing a solution that is pleasing to both Physicians and patients. In the coming days, weeks and months I will help identify areas of concern and opportunity.
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