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Latest From Ferdous Al-Faruque
Following several cases highlighting medical device cybersecurity vulnerabilities and concerns from experts and lawmakers about the federal government's response, FDA is joining with Homeland Security and the National Science Foundation to hold a two-day workshop to discuss potential gaps and how to fix them.
Two US FDA advisory committee meetings are scheduled for May. One will delve into a new organ-transplant device intended to keep organs viable longer, while the other will present recommendations on how the agency should spend funds from the 21st Century Cures Act.
Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.
While Edwards Lifesciences was hoping for a 510(k) clearance later in the year, the company got the greenlight to market its new hemodynamic monitoring system, HemoSphere, in the first quarter.
While there are still a few months to go before the US FDA's Center for Devices and Radiological Health closes its customer service survey, the initial results look to be trending in the agency's favor. With almost nine-in-ten respondents giving a positive review, the results support the agency's efforts to improve customer service.
Soon before it was set to take Alere to court in an attempt to break out of an acquisition deal, Abbott has reversed course and plans to buy the company for half a billion less than the original price tag.