Sample issueBuilt by our monitor from real public sources for the week of 2026-10-11. Links go to the primary source. Sample only; not yet sent to subscribers.
Health AI Docket · DRAFT issue for 2026-10-11 · not sent
This week: openFDA shows 5 candidate AI clearances decided Sep 21 to 27, mostly updates to established imaging platforms: iSchemaView's Rapid Platform R6.7, Siemens' syngo.CT Brain Quantification and Visiana's BoneXpert. openFDA was last refreshed Sep 28, so later decisions will show up in coming issues.
Deadline: the generative-AI device comment window (docket FDA-2026-N-7874) closes October 19.
Trials: 36 AI-related studies were first posted. Two large pragmatic designs stand out: Region Skane's AI decision support for acute chest pain (n=4,500) and Unity Health Toronto's AI-assisted discharge summaries.
[Sponsor slot: empty. Any sponsor is labeled 'Sponsored'; no supplement, device-claim or investment sponsors.]
Deadline watch
- 2026-10-19: Comments due: FDA discussion paper on regulating generative AI-enabled medical devices (docket FDA-2026-N-7874) link
New AI-candidate device clearances (FDA decisions 2026-09-21 to 2026-09-27)
- syngo.CT Brain Quantification by Siemens Medical Solutions USA, Inc. (K260055, 2026-09-25). Substantially Equivalent; product code QIH; Traditional. Candidate: software product code QIH. link
- Syneris PACS v.1.0.1.0 by Syneris (K261874, 2026-09-23). Substantially Equivalent; product code LLZ; Traditional. Candidate: software product code LLZ. link
- BoneXpert by Visiana (K262390, 2026-09-22). Substantially Equivalent; product code QIH; Traditional. Candidate: software product code QIH. link
- HipStudio Analysis by Replasia BV (K262442, 2026-09-22). Substantially Equivalent; product code LLZ; Traditional. Candidate: software product code LLZ. link
- Rapid Platform (R6.7) by Ischemaview, Inc. (K261368, 2026-09-21). Substantially Equivalent; product code QIH; Traditional. Candidate: software product code QIH. link
Federal Register: FDA and CMS
- No AI- or software-related FDA/CMS Federal Register documents published 2026-10-04 to 2026-10-10.
FDA news
- No device- or AI-related FDA press releases this week.
Notable new AI trials on ClinicalTrials.gov (6 of 36 AI-related studies first posted 2026-10-04 to 2026-10-10)
- AI-based Decision Support in Acute Chest Pain: Region Skane. INTERVENTIONAL; NA; NOT_YET_RECRUITING; n=4500; Myocardial Infarction, Chest Pain. link
- The Impact of AI-Assisted Diagnosis and Treatment on Physicians' Potential Legal Liability: An Expert Perspective: Xie Xiaoyun. INTERVENTIONAL; NA; NOT_YET_RECRUITING; n=440; Medical Malpractice, Artificial Intelligence in Medicine, Clinical Decision-Making. link
- Trial of a Voice-Based Generative AI Emotional Support Companion: University of Cologne. INTERVENTIONAL; NA; COMPLETED; n=400; Anxiety and Fear. link
- Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT): Aydin Adnan Menderes University. INTERVENTIONAL; NA; RECRUITING; n=240; Urolithiasis, Kidney Calculi, Ureteral Calculi. link
- AI-Based Conversational Social Support for Older Adults With Heart Failure: Chang Gung University of Science and Technology. INTERVENTIONAL; NA; RECRUITING; n=174; Heart Failure, Social Frailty, Sarcopenia. link
- DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes: Dr. Juwayria Omar. INTERVENTIONAL; NA; NOT_YET_RECRUITING; n=140; Type 1 Diabetes Mellitus, Diabetes Self-Management Education, Caregiver Burden. link
Method: openFDA data last updated 2026-09-28 (about a 2-week lag), so clearances run 2 weeks behind other sections. Device items are flagged by product code or name and are not FDA-confirmed AI. Information only, not medical, legal or regulatory advice.