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Latest From Ferdous Al-Faruque
As the 2017 window to fully repeal the medical device tax has all but closed, lawmakers and industry are now focusing on another extended moratorium of the tax. A new bill proposes to give medical device-makers more time without the tax to develop business plans and more breathing room for Congress to consider a full repeal. Medtech Insight speaks with co-sponsor Rep. Erik Paulsen and industry advocates.
US FDA dropped three big digital-health guidances related to medical software as part of its initiative to help to streamline a path to market for a sector that is "increasingly embraced" by the health system and needs regulatory certainty, according to agency. But initial industry reaction to perhaps the most highly anticipated of the document, on clinical-decision-support software, is somewhat critical.
The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.
A year and a half after FDA issued a draft guidance to help makers of devices that rely on additive manufacturing, the agency has finalized the document in its bid to get ahead of the technology. The final guidance makes minor clarifications, but for the most is identical to the draft.
FDA has approved FoundationOne CDx, the first next-generation sequencing test to clear the agency's expedited access pathway as a breakthrough-designated diagnostic. The companion diagnostic also nabbed a positive national Medicare coverage propose simultaneously thanks to the FDA/CMS Parallel Review Program.
During his first Senate confirmation hearing, top Democrats attacked Trump HHS secretary nominee Alex Azar for his ties to the pharmaceutical industry and support of right-wing ideology espoused by the White House.