MedTech Leading Voice newsletter, issue 182
MedTech Leading Voice - Issue 182 From the Editor A sign of the times: I spent last week at RAPS Convergence in Charlotte walking a floor of roughly a hundred vendors. Around three-quarters of them mentioned AI somewhere in the pitch.
A sign of the times: I spent last week at RAPS Convergence in Charlotte walking a floor of roughly a hundred vendors. Around three-quarters of them mentioned AI somewhere in the pitch.
Meanwhile, from Singapore, Stephanie Grassmann shared five updates on the 30th Annual IMDRF Meeting.
🔥 Five posts this week circle the same question from the regulatory side, starting with Jason Shafrin on how FDA is approaching generative AI-enabled devices. Martin King's roundup points at UK medical device and healthcare AI reform in the same week.
— Sean Smith
FDA's evolving approach to regulating generative AI-enabled medical devices
Jason Shafrin discussed how FDA is approaching the regulation of generative AI-enabled medical devices. For any team with a model inside the product, that approach is what sets the review path.
Four related posts this week:Vanessa Rivel analyzed trends in FDA-authorized AI/ML medical devices and PCCP adoption. Keith Zielenski underscored the need for stronger governance of AI-enabled healthcare technologies. Yujan Shrestha explained the regulatory advantages of unbundling software from medical device hardware. Daniel G. Aaron covered a new FDA law symposium issue with perspectives on medical devices, AI, and FDA policy. For teams putting a model in front of a reviewer this year, that is the reading list.
Stephanie Grassmann of MedTechXperts attended the industry sessions of the 30th IMDRF meeting in Singapore on Sept. 14 and 15, hosted by HSA, and wrote five posts about what she heard. She noticed how much of the discussion went to convergence and how little went to reliance, and put a question to the IMDRF panel about it.
She noted that Welt, a software company, described five countries with five regulatory pathways and a regulator that requested a second clinical study without giving the grounds.
She also wrote up Ben Kokx of Philips arguing that a device has to be assessed as part of the hospital systems and people around it, then told her own story about an outsourced server farm that went down for hours because the provider had never patched it.
"Clinical evidence requirements for software/ AI is a regulatory mess in the EU."
See her five most recent posts >>
Tuesday, September 22, 2026, 11:00 AM to 12:30 PM ET — FDA Ground Truth 2026
Six experts, 90 minutes. Featuring Steve Silverman (President, The Silverman Group), Philip Desjardins (Partner, Arnold & Porter), David Filmore (Executive Editor, Market Pathways), Jeff Lipps (Regulatory Affairs and Quality Assurance Consultant), Angelina Lisandrelli (Director of Global Regulatory, Intuitive) and Michelle Lott, RAC (Principal and Founder, leanRAQA).
September 14, 2026 | From Marcus Engineering, LLC
70 clearances this week, including 33 first-time clearances (🚀).
Featured clearances:
September 14, 2026 | By Martin King
Martin King reads regulatory change this week as a lifecycle matter, running from classification and submission readiness through manufacturing, outsourcing, digital data, inspection and post-market performance. Across medicines, medical devices and IVDs, that means earlier regulatory engagement alongside stronger post-market, inspection and data-governance expectations.
What stands out this week: digital regulatory operations, inspection and outsourcing oversight, classification, post-market safety and quality signals, UK medical device and healthcare AI reform, manufacturing flexibility with conditions, earlier regulatory engagement, and MDR Article 17. This edition is a flipbook, with every source reachable by QR code or through the Index of Indexes.
Sean 🐝
Also published on LinkedIn: issue 182.