Comments close on FDA's generative AI device framework
The comment period on FDA's generative AI device discussion paper closed October 19. The paper proposes a two-axis risk framework and a premarket competency assessment built on non-clinical benchmarking followed by clinical confirmation.
Every 510(k) clearance and original PMA approval from the last 12 months, with panel, product code and applicant, matched against the startup directory. 3,299 decisions on file, newest Oct 11, 2026.
THE FRONT
FDA cleared Sequel Med Tech's twiist automated insulin delivery system for adults with insulin-treated type 2 diabetes. The 307-patient pivotal trial cut HbA1c by 0.7 points and raised time in range from 57 percent to 73 percent.
GuidelinesAAO-HNSF published an updated tinnitus clinical practice guideline on October 12 with a new statement on bimodal neuromodulation. Neuromod Devices said October 16 that its De Novo authorized Lenire device is named in it.
AcquisitionMiMedx and Sanara MedTech received FTC second requests on October 15 over the $350M cash and stock merger announced in July. The Hart-Scott-Rodino waiting period now runs 30 days past substantial compliance.
Asset saleLabcorp agreed to buy clinical, women's health, urology and correctional testing businesses from Opko Health's BioReference Health for $722M upfront and up to $150M more tied to 4Kscore revenue.
Early alertFDA posted an early alert on October 15 about the Commander M delivery system used to implant the Edwards SAPIEN M3 mitral valve. Edwards has three reports of the balloon bursting during inflation, with one death and one serious injury.
HireEndoQuest Robotics named former HCA Healthcare robotics VP Jared Eben chief commercial officer on October 15. The Houston company is preparing a De Novo request for its endoluminal surgical robot and targets a US launch next year.
BUILD YOUR SUBMISSION
Six stages, from “does Section 524B apply” to the metrics you report after clearance, every requirement cited to FDA’s February 3, 2026 guidance.
The same gaps recur across premarket and postmarket review. Here is the deficiency language reviewers actually send, paired with what the guidance says closes each one.
PathwayThe pathway decides your evidence, your timeline and your fee. Here is how the three fit together, the FY2027 numbers, and the small business determination that cuts a 510(k) fee by three quarters.
ResourcesThe eSTAR checklist, cover letter, substantial equivalence table, predicate log, Pre-Sub package, threat model, SBOM report and the rest, in editable Word and Excel.
NOTABLE DECISIONS
| Decision | Number | Device | Applicant | Panel | Code |
|---|---|---|---|---|---|
| Oct 11, 26 | K253717510(k) | Helo Return | Endovascular Engineering, Inc. | Anesthesiology | CAC |
| Oct 6, 26 | K261141510(k) | OpenFlo Urinary Catheter | Urolution Medical, Inc. | Gastroenterology, Urology | EZL |
| Oct 6, 26 | K262798510(k) | LOBO Vascular Occlusion System | Okami Medical, Inc. | Cardiovascular | KRD |
| Oct 5, 26 | K260005510(k) | MyoVista wavECG (DG-200-B15-003) | HeartSciences, Inc. | Cardiovascular | DPS |
| Oct 2, 26 | K260064510(k) | Neurora | Argus Cognitive, Inc. | Neurology | QPF |
| Oct 2, 26 | K260490510(k) | Ninenovo Blood Oxygen Ring (BORMB-01-6,BORMB-01-7,BORMB-01-8,BORMB-01-9,BORMB-01-10,BORMB-01-11,BORMB-01-12,BORMB-01-13,BORMB-01-14) | Shenzhen Ninenovo Technology Limited | Cardiovascular | DQA |
| Oct 1, 26 | K261612510(k) | SwiftSight-BodyComposition | Airs Medical, Inc. | Radiology | LNH |
| Sep 29, 26 | DEN260007510(k) | SmartRead(TM) Medical Device Identifier (4100) | BridgeSource Medical Corporation | Cardiovascular | SJJ |
A working directory of medical device startups from the last five years, by category, with FDA status and funding where it is public.