Sample issueBuilt by our monitor from real public sources for the week of 2026-10-04. Links go to the primary source. Sample only; not yet sent to subscribers.
Health AI Docket · DRAFT issue for 2026-10-04 · not sent
This week: openFDA shows 8 candidate AI clearances decided Sep 14 to 20. The one to note is Epic Systems' Deterioration Index Version 2 (K260008, product code QNL), which brings an EHR vendor's in-workflow prediction model through 510(k). Qure.ai's qCT Lung and A2z Radiology's abdominal triage tool continue the steady flow of imaging AI.
Deadline: comments on FDA's generative-AI device discussion paper are due October 19 (docket FDA-2026-N-7874). No AI-related FDA or CMS Federal Register documents were published this week.
Trials: 40 AI-related studies were first posted on ClinicalTrials.gov, led by imaging, cardiology and chatbot-support studies.
[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 2026-09-14 to 2026-09-20)
- Elucid PlaqueIQ by Elucid Bioimaging, Inc. (K261855, 2026-09-18). Substantially Equivalent; product code LLZ; Traditional. Candidate: software product code LLZ. link
- Deterioration Index Version 2 by Epic Systems Corporation (K260008, 2026-09-18). Substantially Equivalent; product code QNL; Traditional. Candidate: software product code QNL. link
- EchoPAC Software Only / EchoPAC Plug-in (v211) by GE Medical Systems Ultrasound and Primary Care Diagnostics (K261623, 2026-09-16). Substantially Equivalent; product code QIH; Traditional. Candidate: software product code QIH. link
- a2z-Abdo-Triage by A2z Radiology Ai, Inc. (K260906, 2026-09-16). Substantially Equivalent; product code QAS; Traditional. Candidate: software product code QAS. link
- Artificial Intelligence Renal Assessment (AIRA) Version 1 by Aramis Global AI Consultancies, LLC (K261677, 2026-09-15). Substantially Equivalent; product code QIH; Traditional. Candidate: software product code QIH. link
- OOOPDS by Taiwan Main Orthopaedic Biotechnology Co., Ltd. (K254214, 2026-09-15). Substantially Equivalent; product code LLZ; Traditional. Candidate: software product code LLZ. link
- SPINEsim v1.0 by Mdsim S.A. (K261861, 2026-09-15). Substantially Equivalent; product code LLZ; Traditional. Candidate: software product code LLZ. link
- qCT Lung (v1.0) by Qure.Ai Technologies Pvt. , Ltd. (K261517, 2026-09-14). Substantially Equivalent; product code QDQ; Traditional. Candidate: software product code QDQ. link
Federal Register: FDA and CMS
- No AI- or software-related FDA/CMS Federal Register documents published 2026-09-27 to 2026-10-03.
FDA news
- No device- or AI-related FDA press releases this week.
Notable new AI trials on ClinicalTrials.gov (6 of 40 AI-related studies first posted 2026-09-27 to 2026-10-03)
- Venipuncture Via Nurse-AI Collaboration: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. INTERVENTIONAL; NA; NOT_YET_RECRUITING; n=3500; Peripheral Venous Cannulation for Contrast-enhanced CT/MRI Examination, Peripheral Venous Access Establishment. link
- A Novel Multi-functional Artificial Intelligence System on Treatment Efficacy and Implementation in Colonoscopy: Chinese University of Hong Kong. INTERVENTIONAL; NA; NOT_YET_RECRUITING; n=2818; Colorectal Cancer (CRC) Screening. link
- Artificial Intelligence-assisted Primary Care for RSV Prevention (AIPC-RSV) in China: Fudan University. INTERVENTIONAL; NA; NOT_YET_RECRUITING; n=1500; RSV Immunization. link
- Clinical Application of a Low-Dose CBCT AI Model: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. INTERVENTIONAL; NA; RECRUITING; n=1380; Cerebrovascular Diseases, Lung, Liver. link
- Artificial Intelligence in Embryo Selection in Assisted Reproduction for Embryos Cultured to the Fifth Day of Development: University Hospital, Clermont-Ferrand. INTERVENTIONAL; NA; RECRUITING; n=550; Infertility. link
- Artificial Intelligence-Based Virtual Reality on Patient With Upper Gastrointestinal Endoscopy: Al-Zaytoonah University of Jordan. INTERVENTIONAL; NA; COMPLETED; n=500; Patient Anxiety During Upper Gastrointestinal Endoscopy. 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.