Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.
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In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
More than 160,000 of the tests were recalled, including 104,900 COVID Test Kits Nonsterile and 61,500 Clean Catch Urine Kits.
In this revealing interview, the new acting director of the US FDA’s Digital Health Center of Excellence talks about his new role at the DHCOE, the big shoes he’ll have to fill now that former center head Bakul Patel is gone, the need for new regulatory frameworks for digital health – and how he helped repair the Hubble Space Telescope.