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Acquisition: GE Healthcare acquires U-Systems' breast ultrasound screening technology

November 9, 2012 by MassDevice staff

GE Healthcare acquires ultrasound breast cancer screening devices maker U-Systems, which could help GE Healthcare expand its breast care portfolio from screening to monitoring.

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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.

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Breast cancer: FDA approves 1st dense-tissue mammogram system

September 18, 2012 by MassDevice staff

The FDA approves U-Systems' Somo•v breast cancer detection system, the 1st ultrasound system indicated for dense breast tissue.

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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.

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Boston Scientific's Innova peripheral stent débuts in Europe | Regulatory Roundup

May 15, 2012 by MassDevice staff

Boston Scientific, CE Mark in hand, says it plans to get its Innova peripheral vascular stent on the market immediately; also, Health Canada warns on metal-on-metal hip implants; U-Systems wins FDA approvable letter for breast ultrasound PMA; Maquet lands 510(k) for new aortic balloon catheter sizes; and more.

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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.

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U-Systems' breast cancer tool wins FDA panel nod

April 12, 2012 by MassDevice staff

The FDA's radiological devices panel recommends approval of U-Systems' somo•v ultrasound-based breast cancer screening system.

U-Systems logo

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.

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Breast cancer: U-Systems lands FDA date for breast ultrasound | Regulatory Roundup

February 27, 2012 by MassDevice staff

U-Systems wins a date with an FDA advisory panel to move forward on a pre-market application for the somo.v, the first ultrasound device to target breast cancer screening.

FDA logo

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.

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GE Healthcare begins PMA process for 3D breast scanner | Regulatory Roundup

November 11, 2011 by MassDevice staff

GE Healthcare files the first module of a pre-market approval application for its Senographe Essential breast tomosynthesis device ; also, Maquet wins 510(k), CE Mark for CardioSave IABP; J&J's Ethicon Endo-Surgery gets 510(k) nod for Enseal G2 tissue sealers; and Cordis lands clearances for Empira dilation catheters.

GE Healthcare's Senographe Essential

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.

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Medtronic lands EU approval for CoreValve | Regulatory Roundup

August 18, 2011 by MassDevice staff

Medtronic's CoreValve aortic valve replacement system wins CE Mark approval in the European Union.

Medtronic

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.

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