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Latest From Ferdous Al-Faruque
Promising new results from a pilot study of Abiomed’s Impella device to reduce damage after myocardial infarction sets the company up to start a pivotal study, which, if successful, could change how patients are treated immediately after an attack.
The "lame duck" session of Congress before newly elected members take their seats in January may be the best shot available for the device industry to win permanent device tax repeal, lobby group AdvaMed says. The group is making a major effort to repeal the tax before the new Congress takes over.
On this week's podcast, David Filmore and Ferdous Al-Faruque discuss the results of this week's midterm elections in the US and what it could mean for the medtech sector.
Recently announced US National Evaluation System for health Technology "test cases" will be evaluated for up to a year by the NEST Coordinating Center after which collaborating device-makers may be in a better position to use real-world evidence to support new pre-market device submissions. The test cases will be measured, in part, based on their ability to identify brand-specific devices in the NEST Network Collaborators’ real-world datasets.
FDA's policies and procedures do not adequately address how to handle post-market device cybersecurity events and the agency had not adequately tested its ability to respond to emergencies arising from such events, US HHS' investigative arm says. But the top cybersecurity official at FDA's device center says OIG's report is "incomplete and inaccurate."
A day after 23andMe gained US FDA go-ahead for a DTC genetic test service to inform patients about their ability to metabolize medications, the agency issued a safety communication, paired with a joint statement from device- and drug-center heads, warning consumers against trusting genetic tests that have not been vetted by FDA.