STAT+: AI medical devices’ dirty FDA secret

STAT PlusNewsletterAI Prognosis AI medical devices’ dirty FDA secret You’re reading the web edition of STAT’s AI Prognosis newsletter Manage alerts for this article Email this article Share this article By Brittany TrangMay 13, 2026 Health Tech Reporter Brittany Trang[email protected]Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01. You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life sciences. Sign up to get it delivered in your inbox every Tuesday and Thursday. I’ve been loving the satire on the “In Preparation” Substack, which includes fake articles like “Nobel Laureate Jennifer Doudna Leaves Science For Trade School, Tells Postdocs ‘Learn Welding While You Can.’”Advertisement I’ll be in San Francisco May 18 – 20 for the STAT Breakthrough West Summit. Even if you can’t make it to our very cool event, let me know if you want to meet up and talk AI or data, have a cool lab to show me, or just want to grab some ice cream: [email protected] STAT+ Exclusive Story Already have an account? Log in This article is exclusive to STAT+ subscribers Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts. Already have an account? Log in Monthly $39 Totals $468 per year $39/month Get Started Totals $468 per year Starter $30 for 3 months, then $399/year $30 for 3 months Get Started Then $399/year Annual $399 Save 15% $399/year Get Started Save 15% 11+ Users Custom Savings start at 25%! Request A Quote Request A Quote Savings start at 25%! 2-10 Users $300 Annually per user $300/year Get Started $300 Annually per user View All Plans To read the rest of this story subscribe to STAT+. Subscribe Log In Artificial intelligence, health tech, STAT+ Submit a correction requestReprints Brittany Trang Health Tech Reporter Brittany Trang, Ph.D., covers AI in health and medicine: Does it actually work? Who benefits, or might be harmed? She writes the weekly AI Prognosis newsletter. Follow her on Threads, Mastodon, and Bluesky. You can reach Brittany on Signal at btrang.01. Newsletter Tech is transforming health care and life sciences. Our original reporting is here to keep you ahead of the curve. Recommended AI Prognosis May 6, 2026 STAT Plus: When the path to good AI is littered with bad data AI Prognosis April 29, 2026 STAT Plus: Why conversations around health AI may be evolving beyond hype Advertisement AI Prognosis April 15, 2026 STAT Plus: A $15 AI test, Project Glasswing, and how Doctronic pilot blindsided Utah medical board AI Prognosis April 8, 2026 STAT Plus: Are AI scribes actually driving higher health care costs? AI Prognosis April 1, 2026 STAT Plus: Insilico Medicine CEO on how best to use AI in drug development Subscriber Picks