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More warnings on metal-on-metal hip implants in U.K, New Zealand | Regulatory Roundup

April 16, 2012 By MassDevice staff Leave a Comment

hip x-ray

Filed Under: 510(k), Implants, News Well, Orthopedics, Recalls Tagged With: Chromogenex, Custom Spine, depuysynthes, Hips, ITGI Medical Ltd., Spacelabs Healthcare, Stryker

Edwards lands CE Mark for Intuity valve | Regulatory Roundup

February 16, 2012 By MassDevice staff Leave a Comment

Edwards Lifesciences logo

Edwards Lifesciences Corp. (NYSE:EW) landed CE Mark approval in the European Union for its Intuity valve system.

The Intuity valve, made of bovine pericardial tissue, is a minimally invasive option for patients in need of aortic valve replacement.

Filed Under: News Well, Pre-Market Approval (PMA), Replacement Heart Valves Tagged With: Accurate Set, ClinACE, Custom Spine, Delcath Systems Inc., depuysynthes, Edwards Lifesciences, HeartWare International Inc., Medasys, Stereotaxis, Velomedix Inc.

Toshiba lands 510(k) for latest Aquilon CT scanner | Regulatory Roundup

February 1, 2012 By MassDevice staff Leave a Comment

Toshiba

Toshiba’s (TYO:6502) American medical products division won 510(k) clearance from the FDA for the latest iteration in its Aquilon line of CT scanners.

The Aquilon Prime is designed for healthcare facilities that need to perform a wide variety of advanced clinical examinations with reduced radiation exposure, according to a press release.

Filed Under: 510(k), News Well Tagged With: Avedro Inc., Bovie Medical Corp., CardioKinetix Inc., Charter Medical, Custom Spine, Regulatory Roundup, TearScience, Toshiba, Yolo Medical

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