Healthcare giant GE Healthcare (NYSE:GE) acquired U-Systems and with it the 1st FDA-approved ultrasound-based dense-tissue mammogram adjunct, the Somo•v automated breast ultrasound.
Breast cancer: FDA approves 1st dense-tissue mammogram system
The FDA approved U-Systems‘ Somo•v breast ultrasound system, the only automated system in the U.S., Canada and 27 European Union countries indicated for use in combination with standard mammography for asymptomatic women with dense breast tissue.
Dense breast tissue, which occurs in nearly half of women, increases the risk of breast cancer up to 4-to-6 times and can also make the cancer more difficult to detect with mammography, some studies have shown.
Boston Scientific’s Innova peripheral stent débuts in Europe | Regulatory Roundup
Boston Scientific (NYSE:BSX) said it plans to get its Innova stent for peripheral artery disease on the market in the European Union "immediately" now that it’s won CE Mark approval there.
U-Systems’ breast cancer tool wins FDA panel nod
The FDA’s radiological device panel voted to recommend U-Systems‘ Somo•v automated breast ultrasound system for pre-market approval as a breast cancer screening tool.
If approved, Somo•v would be the only ABUS system in the U.S. indicated for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.
Dense tissue in the breasts may pose an increased risk of cancer and represents a challenge for traditional mammography, according to a press release.
Breast cancer: U-Systems lands FDA date for breast ultrasound | Regulatory Roundup
U-Systems won a date with the FDA to review its pre-market application for the first ultrasound device indicated for breast cancer screening.
The somo.v Abus device, which is set to undergo agency review on April 11, 2012, is already FDA-cleared for diagnostic use as an adjunct to a mammogram.
GE Healthcare begins PMA process for 3D breast scanner | Regulatory Roundup
GE Healthcare (NYSE:GE) filed the first module of its pre-market approval application for the breast tomosynthesis option of its Senographe Essential system.
The health care giant said the first submission included a device description and non-clinical information, including "phantom testing," and detector performance evaluation. The system is intended as an add-on option for the Senographe Essential to produce 3D images for screening and diagnosis of breast cancer.
Medtronic lands EU approval for CoreValve | Regulatory Roundup
Medtronic Inc. (NYSE:MDT) won CE Mark approval in the European for its percutaneous aortic valve replacement system, CoreValve.
The device is "the only transcatheter aortic valve available in the world that can treat – without surgery – patients with larger valve openings (up to 29mm)," according to a press release.
CoreValve is the largest transcatheter valve available, but can compress into a small delivery system to be deployed in the same delivery system as smaller CoreValve sizes.
Potential new risk factor for heart disease discovered | Research roundup
Here’s a roundup of recent clinical trial and scientific study news:
U-Systems lands European approval for ultrasound-based breast cancer screening
U-Systems won CE Mark approval in the European Union for its Somo-V automated ultrasound breast cancer screening system.
The Sunnyvale, Calif.-based ultrasound technology firm said the device is intended as an adjunct to mammography to aid in breast cancer detection for physicians diagnosing symptomatic or asymptomatic women, according to a press release.