FDAnews Device Daily Bulletin
Aug. 14, 2012 | Vol. 9 No. 159
The FDA Wednesday said it is limiting use of Stryker’s Wingspan brain stent, but stopped short of removing the device from the market entirely — as consumer advocates had urged.
Failure to report adverse events from a battery-operated toothbrush were among several observations in a Form 483 generated after a Jan. 9 to Feb. 13 inspection of Church & Dwight’s Princeton, N.J., facility.
The FDA needs to provide more specifics on what nanotechnology products it is regulating and in what ways, members of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee said Thursday.
An Ohio federal judge ruled Friday that Ohio Willow Wood’s patent for liners used in certain prosthetics was invalid, handing a win to rival Alps South in a protracted fight over technology for amputees.
BG Medicine, the maker of an FDA-approved diagnostic test for heart failure, saw its shares fall almost 6 percent Thursday.
Johnson subsidiary Cordis wasn’t able to dodge all the complaints in a patient injury lawsuit after a New Jersey Supreme Court Judge upheld certain arguments against the company’s Cypher coronary stents.
Stryker Neurovascular announced that its Trevo Pro Retriever has been granted 510(k) market clearance by the FDA.
The intricate properties of the fingertips have been mimicked and recreated using semiconductor devices in what researchers hope will lead to the development of advanced surgical gloves.
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