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Boston Scientific wins FDA nod for latest pacemaker set

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MassDevice.com news

Boston Scientific (NYSE:BSX) said the FDA approved the latest set of its pacemakers, including a device designed to treat patients who can’t regulate their heartbeats while exercising.

The Natick, Mass.-based med-tech maker said the watchdog agency granted pre-market approval for its Ingenio and Advantio pacemakers and for its Invive cardiac resynchronization therapy pacer.

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

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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.

FDA clears St. Jude’s first-to-market hybrid FFR/OCT blood vessel imaging system | Regulatory Roundup

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St. Jude

St. Jude Medical Inc. (NYSE:STJ) got the FDA’s green light for the U.S. market’s first combined FFR/OCT blood vessel imaging system for diagnosis and treatment of coronary artery disease.

The Ilumien system combines St. Jude’s PressureWire Aeris wireless fractional flow reserve imaging technology, which allows physicians to visualize blood vessel characteristics, and its Extreme Resolution optical coherence tomography, which helps evaluate the severity of blood flow blockages in coronary arteries.

Bard CFO has one foot out the door, will retire when someone fills his shoes | Personnel Moves

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CR Bard

C.R. Bard Inc.’s (NYSE:BCR) senior VP and chief financial officer Todd Schermerhorn announced his retirement after 26 years with the company.

Schermerhorn will continue to serve as CFO until the Murray Hill, N.J.-based company finds a replacement, which may take until August 2012.

DePuy gets FDA clearance for new hip amid lawsuit over old hip | Regulatory Roundup

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M and A Roundup

Amid lawsuits concerning its Pinnacle metal-on-metal hip implant, Johnson & Johnson (NYSE:JNJ) subsidiary DePuy Orthopaedics won U.S. Food & Drug Administration clearance for its next-generation Pinnacle ceramic-on-metal hip implant.

Ceramic-on-metal is a novel combination in the hip implant market, having undergone two-year controlled, randomized, multicenter, non-inferiority clinical study and laboratory testing as part of the clearance process.

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