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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...
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 reg...
Yujan Shrestha
ArticleNews
A reflection on how Innolitics revisits its mission and values at the annual retreat—and why that exercise sharpens judgment, s...
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...
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 clini...
Yujan Shrestha
ArticleNews
April Fools 2023 Joke: New FDA AI/ML Draft Guidance: Recommendations and Risk Assessment of Generative (AI/ML)-Enabled Quality ...
J. David Giese
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