Track FDA guidance on digital health, Software as a Medical Device and AI/ML-enabled devices — concise, fully-sourced, and tracked as drafts move to final.
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The classification establishes a defined regulatory pathway for simple in vitro diagnostic devices detecting Bacillus species secreted proteins in human clinical samples, potentially accelerating market access. The FDA has issued a final order classifying the simple in vitro diagnostic (IVD)...
A new analysis in npj Digital Medicine traces the growth and evolving patterns of FDA clearances and approvals for digital medical devices over 20 years, offering a data-driven baseline for the field. A peer-reviewed study published in npj Digital Medicine on June 17, 2026 examines two decades of...
The FDA's new framework explicitly acknowledges that AI software changes over time, shifting regulatory emphasis toward ongoing risk controls, transparency, and accountability rather than one-time pre-market review. The Food and Drug Administration has released draft guidance specifically...
A peer-reviewed framework in npj Digital Medicine argues that knowing when to withhold an answer may be as critical as accuracy for safe clinical deployment of large language models. A review article by Michael A.
Fully-sourced weekly briefs, tracked from proposal to final.
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