Category: Food & Drug Administration (FDA)
Medtech maker Cardiovascular Systems touts FDA clearance for a 60cm model of its Diamondback 360 peripheral orbital atherectomy system.
Minnesota-based Cardiovascular Systems (NSDQ:CSII) landed FDA clearance for a new size of its Diamondback 360 atherectomy system, used in treatment of peripheral artery disease.
FDA medtech regulators cite a "significant scheduling conflict" in moving EnteroMedics' advisory panel meeting from May to June.
Minnesota medical device maker EnteroMedics (NSDQ:ETRM) announced today that it's May 2014 date the FDA had been bumped a few months back.
Healthcare apps are in high demand, but mobile developers aren't clear on when their products should undergo FDA review.
MASSDEVICE ON CALL — Mobile app developers are growing increasingly interested in healthcare, creating something of a crisis of regulation.
Valor Medical and 4 of its top brass admit to concealing required data from FDA regulators while undergoing review for an aneurysm treatment implant.
California biotech company Valor Medical, 4 executives and a consultant admitted to the Dept. of Justice that they concealed information about their Neucrylate diagnostic assay, hiding toxicity reports that were required as the product was undergoing FDA premarket review.
The FDA warns on new issues with GE Healthcare's neonatal warmers and resuscitation systems, which were recalled in October 2013.
Federal healthcare regulators put their highest-risk Class I label on a new warning issued over GE Healthcare's (NYSE:GE) Giraffe and Panda neonatal infant warmers and resuscitation systems.