Medicare Proposes NTAP For Breakthrough Treatment Of Spinal Condition
US Medicare has granted a new technology add-on payment (NTAP) for an innovative technology designed to treat adult spinal deformity.
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News We’re Watching: Disease X Act, Abiomed Recall, TAVR AI Cleared
This week, the bipartisan Disease X Act for pandemic preparedness was introduced in the US House of Representatives; Abiomed Impella pumps were the subject of a class I recall; Dasi Simulations and Endologix landed FDA clearances; and the FDA warned against the use of Getinge/Maquet Oxygenators.
FDA Seeks Feedback On Attempt To Modernize Clinical Trials
The US FDA has released a draft guidance from the International Council for Harmonisation that aims to modernize clinical trials. The agency is requesting feedback on the draft, which includes updates on good clinical practices.
Despite New Hires, Personnel Challenges Remain For FDA
The good news for the FDA is the agency has already hired 2,000 new employees this year; the bad news is they still have 2,000 more to go. FDA chief of staff Julie Tierney discussed some of the agency’s hiring successes and challenges during a recent Alliance for a Stronger FDA webinar.