Category: Food & Drug Administration (FDA)
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.
Federal healthcare regulators are looking for contractors to monitor social media channels for consumer sentiments about FDA activity and for early signs of adverse events and outbreaks.
The FDA is looking to dig into social media in search of clues about public perceptions of FDA efforts and chatter that may signal an uptick in adverse events or an impending outbreak.