Whats new at Innolitics
FeaturedArticleAI/ML
FDA released 17 PDFs of clearances in September 2026. They include some pretty novel stuff including the first cleared device I could find with continuous learning (daily automa...
Yujan Shrestha
FeaturedArticleAI/ML
FDA's Aug 18, 2026 discussion paper proposes grading generative AI medical devices like physicians: benchmarks, then clinical confirmation, then live monitoring. What it says, w...
Yujan Shrestha
FeaturedArticleAI/ML
FDA authorized 86 AI/ML devices in Q2 2026, but the sharper signal came after first clearance: 12 Special 510(k)s, 12 PCCPs, two new De Novo categories, and route choices that c...
Yujan Shrestha
FeaturedArticleAI/ML
FDA's draft MDUFA VI commitment letter (FY2028–2032) restructures how sponsors interact with the agency. Seven changes that will reshape submission planning for software and AI ...
Yujan Shrestha
FeaturedArticleAI/ML
UpDoc is now the clearest public example of an FDA-cleared LLM-enabled medical device. Here's what FDA actually cleared, why the clinical decision still sits behind a determinis...
Yujan Shrestha
FeaturedArticleAI/ML
FDA cleared 24 AI/ML SaMD applications in March 2026 — one every 31 hours. A breakdown of the patterns that matter for sponsors: radiology dominance, PCCP under-adoption, the lo...
Yujan Shrestha
ArticleAI/ML
Key takeaways from the September 25 CDRH–MDIC meeting: regulatory predictability can help restore medtech investment; FDA trust in AI depends on validated methods, credible evid...
James Swink
ArticleAI/ML
FDA publicly rejected Nihon Kohden's letter-to-file decision, so we pulled every warning letter FDA has published — 5,712 of them, 2015–2026 — classified them with AI, and mappe...
Yujan Shrestha
ArticleAI/ML
CMS and CDC are asking whether AI-assisted postanalytic interpretation, digital pathology, cloud analytics, and data-only medical-device software facilities should fall within t...
Yujan Shrestha
ArticleAI/ML
27 AI/ML medical devices authorized in April 2026. Radiology's share of clearances dropped from 79% to 56%, QIH remains the regulatory plumbing for image-processing AI, and PCCP...
Yujan Shrestha
ArticleNews
A reflection on how Innolitics revisits its mission and values at the annual retreat—and why that exercise sharpens judgment, strengthens alignment, and deepens team ownership.
J. David Giese
ArticleAI/ML
The U.S. Senate HELP Committee confirmed what we've been publishing for three years. An analysis of the regulatory signal, what it means for AI device companies, and why the com...
Yujan Shrestha
ArticleAI/ML
Fifteen AI/ML software 510(k) clearances landed in nine days in mid-December 2025. Here’s what got cleared, where it fits clinically, and what it signals for regulated AI momentum.
Yujan Shrestha
ArticleNews
April Fools 2023 Joke: New FDA AI/ML Draft Guidance: Recommendations and Risk Assessment of Generative (AI/ML)-Enabled Quality Management and Premarket Submission Review
J. David Giese
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