COVID-19-Related EUAs Bolster Record Number Of Novel Devices Greenlit By FDA
According to top FDA officials Jeff Shuren and William Maisel, regulators approved, cleared and authorized 132 novel devices up from its previous record of 106. It’s in large part due to EUAs for novel COVID-19 products issued last year.
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The head of the US agency’s device center tells Medtech Insight that while he’s proud of his staff for taking on the extra workload due to the pandemic, product review times are slowing because resources are stretched thin.
Device Week, 26 February 2021 – Inside Integrum’s Journey To Secure FDA Approval For Novel Prosthetic
On this week’s podcast we talk about some hurdles that Swedish start-up Integrum leapt when applying for premarket approval for its Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System.
A former Army ranger, Michael Minogue wants to help military veterans transition into and gain employment opportunities in the medtech industry.