One in five AI/ML 510(k) clearances cites a predicate under a different product code, with 85 devices predicated on a different body region, 35 swapping imaging modality, and 122 crossing 21 CFR regul…
The U.S. Food and Drug Administration (FDA) does not mandate a universal sample size for sensitivity and specificity studies, but its final 2025 guidance for AI-enabled device Predetermined Change Con…
On August 5, the U.S. Food and Drug Administration (FDA) named Cadence the second participant in its TEMPO pilot program for HypertensionOS, a software device that generates protocol-bound medication-…
The FDA named Dexcom the first participant in its TEMPO pilot on July 22, 2026, pairing real-world evidence collection with CMS's ACCESS payment model to support wearable diagnostic AI. Dexcom's devic…
FDA issued a warning letter to Nihon Kohden Digital Health Solutions on July 14, 2026, rejecting the company's decision to document a software update as a letter to file instead of submitting a new 51…
The U.S. Food and Drug Administration (FDA) has introduced Predetermined Change Control Plans (PCCPs) as a regulatory tool allowing companies to pre-clear certain device changes within a 510(k), De No…
The Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) published a Request for Information on July 16, 2026, reopening the question of whether AI d…
A consulting firm built a private benchmark of more than 1,200 FDA regulatory judgment questions and tested 18 frontier AI models, finding that every model failed the questions that carry the highest …
The FDA's January 2025 draft guidance on AI-enabled medical devices recommends that model descriptions detail inputs, outputs, architecture, training, and limitations, but the document remains draft a…
The FDA cleared 14 AI/ML-enabled medical devices in Q2 2026, including De Novos and 510(k)s, spanning neurology, cardiology, radiology, and other specialties. Key clearances include neuropacs' MSAp/PS…
The FDA released the draft MDUFA VI commitment letter for FY2028–2032, introducing structural changes to how sponsors interact with the agency, including faster pre-submission feedback, a permanent au…
UpDoc announced on June 25, 2026, that its AI platform received FDA clearance as the first FDA-cleared clinical AI agent and LLM-enabled device, though public records show the clearance (K253281) is f…