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Latest From Elizabeth Orr
Johnson & Johnson and subsidiary Ethicon will pay $117m to settle state lawsuits alleging that their marketing misrepresented the safety and risks of transvaginal mesh devices.
Louisiana-based pharmacogenetic testing company UTC Laboratories and its three principals have agreed to pay $42.6m to resolve allegations that the company violated the False Claims Act by paying kickbacks for referrals and providing tests that were not medically necessary.
A review of German insurance data found no additional risk of death in patients treated with drug-coated balloons and stents, even in patients who had the devices for more than a decade. The data appears to further challenge a bombshell meta-analysis that claimed paclitaxel could increase death rates by up to 90%.
On this week’s podcast, executive editor Shawn M. Schmitt and senior reporter Elizabeth Orr delve into recent news on medical device recalls, including tips and advice from US FDA officials, and a report about a new app that scans products and gives detailed safety and recall information.
Newly finalized guidance from the US agency updates its recommendations for 510(k) submissions for guidewires intended for use in coronary vasculature, peripheral vasculature and neurovasculature. The document, which replaces a 1995 guidance, reflects serious risks posed by certain guidewire coatings.
Officials in the US FDA's recall divisions advised manufacturers on the best ways to work with the agency during the recalls process, including keeping track of who they're speaking with, making sure all required forms are complete, and not being afraid to use eSubmit.