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Latest From Ferdous Al-Faruque
The House Republican conference decision to pull the American Health Care Act from consideration means repeal of the medical device tax has died, at least in the short term. After hours of debate on the floor, and failing to gather enough votes to pass the bill, House Speaker Paul Ryan and President Trump called a halt to the Affordable Care Act repeal effort, saying they will now focus on other objectives, such as tax reform.
FDA issued orders officially finalizing regulatory classifications and special controls for next-generation sequencing analyzers; "secondary display" devices for continuous glucose monitor data; and vibratory counter-stimulation devices for restless leg syndrome. And the agency is working towards formalizing 510(k) exemptions for future devices of these types as well.
Former FDA Commissioner Mark McClellan talked with Medtech Insight about FDA Commissioner-nominee Scott Gottlieb, who he has worked closely with in the past at FDA and CMS. He also discussed 21st Century Cures Implementation, President Trump's budget blueprint and more.
In this video from the inaugural Digital Medtech Conference, in San Francisco, FDA's Bakul Patel discusses the agency's thinking behind a proposed "FDA Precheck" program to expedite the path to market for "software as a medical device" products, and industry players respond.
Developers of "software as a medical device" are unique to other device-makers in how fast their products are developed and updated. FDA digital health leader Bakul Patel is asking companies to provide input on the agency's idea for an expedited pathway for software that would be based on established trust.
AdvaMed's March 2 Digital Medtech Conference was a coming-out party of sorts for its new Digital division, with members including Apple, IBM and Qualcomm. The meeting brought together tech companies large and small that are exploring the medical arena. Here's a video of Medtech Insight's post-conference chat with AdvaMed Chief Strategy Officer Andrew Fish.