LumaGEM MBI system

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A retrospective study in the American Journal of Roentgenology (AJR) August issue confirmed Gamma Medica’s molecular breast imaging (MBI) technology’s high incremental cancer detection rate of 7.7 cancers per thousand (7.7/1000) and overall clinical effectiveness as a secondary screening tool in finding 13 malignancies among 1,696 women with dense breast tissue following mammograms that read negative for cancer. Approximately 85% of these cancers were confirmed to be node negative, indicating they were detected at an early stage and therefore presented a better prognosis.

“This study offers practice-based, clinical proof that for women with dense breast tissue – roughly half the female population in the United States alone – MBI is a powerful tool that finds cancer where a mammogram alone can miss it,” said Dr. Robin Shermis, one of the study’s authors and the medical director at the ProMedica Breast Care Center, where the research took place. The community-based study used data from routine clinical practice at the facility from 2011 to 2014, focusing on women with aged 25-90 with heterogeneously and extremely dense breast tissue. “Following up a mammogram with MBI enables detection of an additional 7.7 cancers per 1000 women screened. It’s also safe and easy to use, delivers almost instantaneous results and is fits perfectly within our workflow.”

The study also confirmed that in addition to delivering a high cancer detection rate, MBI affords patients with a high positive predictive value, a high invasive cancer detection rate, minimal radiation and rapid interpretation allowing for real-time readings. Determined to spread awareness on the high degree of certainty MBI offers compared to more conventional screening technologies, the manufacturer of the LumaGEM MBI system used in the study, Gamma Medica, launched the educational Be Certain campaign last month through creating a dedicated website and various social media channels.

“This new study in the AJR provides further evidence that women with dense breast tissue have more comfortable and less stressful alternatives to standardized secondary screening studies. These recent clinical results suggest there is a real alternative to the risk of misdiagnosis and unnecessary biopsies. Our recently launched Be Certain campaign offers more clinical information to a large population of underserved patients,” said Phil Croxford, Gamma Medica’s CEO, pointing to the need to confront the 40,000 deaths at the hands of breast cancer each year.

For Further Information
More on the breast imaging market in the US can be found in a report series published by iData Research entitled the US Market for Female and Neonatal Diagnostic Devices. The reports cover: bone densitometry, DXA markets, breast biopsy devices, core needle devices, vacuum-assisted breast biopsy devices, breast imaging equipment, mammography, obstetrics and gynecology ultrasound equipment, fetal and neonatal monitoring devices, infant warmer and incubators, NICU, and gynecological chairs.

Full reports also provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about breast imaging market data or procedure data, register online or email us at [email protected] for a US Market for Female and Neonatal Diagnostic Devices report series brochure and synopsis.

About Procedure Tracker
Procedure number data is available from iData’s Procedure Tracker service, which allows subscribers to define and analyze procedure data segmented by state, region, hospital, surgery centre, and physician. A customizable dashboard sorts procedure data for further analysis and research.

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iData Research’s Reimbursement Policy Tracker enables medical device, dental, pharmaceutical and healthcare professionals to receive real-time policy updates from hundreds of insurance companies and 60,000+ policies across all therapeutic areas in the United States.

About iData Research
iData Research (www.idataresearch.com) is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Operating Room Equipment, Surgical Microscopes, Robotics and Surgical Navigation, Laparoscopy, Urology, Gynecology, Vascular Access, Endoscopy, Interventional Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Electrophysiology, Ultrasound, X-Ray Imaging, Diagnostic Imaging, Oncology, Spinal Implants and VCF, Spinal MIS, Orthopedic Soft Tissue Repair and Regeneration, Orthopedic Trauma, Large & Small Joints, Anesthesiology, Wound Management, Orthopedics, Ophthalmics, Dental Operatory Equipment and more.


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