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Latest From Ferdous Al-Faruque
The recent US FDA de novo approvals for heart-rhythm analysis software on Apple's latest Apple Watch, which took about 30 days from submission to a decision that aligned with Apple's high-profile launch event, raised eyebrows in the medtech industry. Some in industry are concerned that the tech giant received preferential treatment over smaller companies, setting a bad precedent. But some say it could be a positive sign for the digital health industry at large.
Greg Crist, the top public affairs executive at AdvaMed, is stepping in to head the trade group's government affairs operations, as JC Scott departs to lead the Pharmaceutical Care Management Association.
Under a new plan and draft guidance issued by US FDA, the agency is hoping to streamline and improve its third-party review program. The goal is to spend substantially less FDA resources re-reviewing low-to-moderate risk 510(k) applications that go through the program and allow products to enter market sooner.
The latest Apple Watch includes an electrocardiogram that has received de novo clearance from US FDA to detect irregular heart rhythms. The approval, say two top US FDA regulators, is a signal to the digital health industry that the agency is trying to help them innovate.
HHS OIG is recommending US FDA hold more pre-submission meetings, amend their Refuse-to-Accept checklist and update their "Smart" template for agency reviewers to improve oversight of medical device cybersecurity.
After years of talking about how to tackle uncertainty of benefit/risk in devices under review, US FDA has released a guidance on the issue. Medtech Insight caught up with FDA device center director Jeff Shuren at a meeting in Washington, DC, to talk about the guidance and what he hopes will come of it.