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.”

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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

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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):

• 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.

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.

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.

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.

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.