U.S. Food and Drug Administration

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28 clearances · 3 authorizations · 2 rules

Trends

• Clinical AI moves into EHR platforms and reimbursement
• FDA authorizations extend clinical AI into new specialties and LLMs

Items

1. Oct 5

   FDA clears AIRS Medical body-composition MRI

   The FDA cleared AIRS Medical's quantitative-MRI AI for body-composition analysis, extending its platform beyond brain imaging with SimonMed Imaging as the first deployment customer.

2. Oct 8

   FDA clears Wellysis S-Patch CardioAI

   The FDA granted 510(k) clearance to Wellysis's AI-powered ECG analysis software for its S-Patch ambulatory cardiac monitor.

3. Oct 5

   FDA clears Happy Ring cuffless blood pressure

   The FDA cleared the first wearable to measure ongoing, clinical-grade blood pressure without a cuff or calibration, using an AI model that builds a personalized physiological baseline from ~2.8M nightly data points and validated against invasive arterial-line readings across 85 patients.

4. Sep 28

   FDA clears Tempus ECG-MR

   The FDA granted 510(k) clearance to an AI product that analyzes standard 12-lead ECGs to flag signs of undiagnosed moderate or severe mitral regurgitation in at-risk patients 65 and older, as an early-detection referral tool.

5. Sep 30

   FDA clears Ceribell quantitative EEG

   The FDA cleared new software that turns raw bedside EEG into simple longitudinal trends and amplitude-integrated analysis with no age restriction, spanning the NICU to the ED and ICU.

6. Sep 28

   FDA clears CapsoVision AI Highlights

   The FDA cleared (letter dated 2026-09-25) an AI reading tool that flags and prioritizes suspected abnormal lesions in small-bowel capsule endoscopy studies, using a competitor's De Novo-authorized tool as its 510(k) predicate.

7. Sep 17

   FDA keeps radiology AI under 510(k) clearance

   A final order effective September 17 requires several categories of AI radiology software, including cancer-lesion detection and urgent-finding triage, to keep obtaining 510(k) clearance, formalizing the FDA's denial of Harrison.ai's petition for a partial exemption.

8. Sep 9

   FDA authorizes Queen of Hearts AI-ECG

   The first De Novo authorization for AI-ECG detection of STEMI and STEMI equivalents creates a new device class for acute cardiac diagnoses; registry data show 7.9% false-positive cath-lab activations with the tool versus 41.8% without.

9. Sep 11

   FDA classifies cardiovascular ML notification software

   A final order codifies a new Class II device type, originating with Viz.ai's Viz HCM, with special controls requiring multi-site, demographically representative validation, standardizing the pathway for AI triage-and-notify tools.

10. Sep 1

    FDA clears Medibyt CPETWise

    The cleared software standardizes cardiopulmonary exercise test analysis, interpretation, and reporting while preserving clinician visibility, with a University of Washington study reporting a more than 50% cut in interpretation time.

11. Sep 2

    FDA clears Heartvue.Proton with a change-control plan

    The 510(k) clearance covers an ML cardiac-MRI platform that automates dimensions, ventricular volumes, ejection fraction, and blood-flow quantification under physician review, with an authorized Predetermined Change Control Plan for bounded model updates.

12. Aug 24

    FDA clears Tempus ECG-PH

    The FDA cleared AI software that reads standard 12-lead ECGs for signs of pulmonary hypertension, an assistive binary readout aimed at earlier detection of a historically underdiagnosed condition and Tempus's third cleared cardiovascular device.

13. Aug 18

    FDA clears Cortechs.ai NeuroQuant PET

    The AI-based molecular-imaging quantification tool for PET extends Cortechs's brain-quantification suite into cognitive-impairment workups.

14. Aug 11

    FDA clears Roen Surgical's Zamenix kidney-stone robot

    Described as the first AI-based flexible ureteroscopic kidney-stone surgical robot, Zamenix checks in real time whether a stone is small enough to pass and fragments larger stones by laser.

15. Aug 11

    CMS opens the RAPID Medicare coverage pathway

    The pathway issues a proposed Medicare National Coverage Determination the same day the FDA authorizes an eligible Breakthrough device, compressing coverage from roughly a year to about two months.

16. Aug 6

    FDA clears Proscia Concentriq AP-Dx with a PCCP

    The digital-pathology platform's 510(k) adds Leica scanner support and cloud deployment, plus a Predetermined Change Control Plan that lets Proscia add future cleared scanners, image formats, and displays without new submissions.

17. Jul 29

    FDA clears ThinkSono Guidance for DVT scans

    The first AI ultrasound-guidance software cleared in the US for suspected lower-extremity deep vein thrombosis lets clinicians without ultrasound training capture diagnostic scans for remote physician interpretation.

18. Jul 28

    FDA clears Implicity's ILR ECG Analyzer

    A manufacturer-agnostic cloud AI layer filters false-positive alerts from implantable cardiac monitors across all major device makers, cutting false-positive episodes by up to 76% while maintaining sensitivity.

19. Jul 30

    FDA clears DeepHealth breast ultrasound AI

    The 510(k)-cleared software automates breast-ultrasound lesion detection, characterization, and reporting and will be deployed across RadNet's network, which handles an estimated 700,000+ breast-ultrasound studies a year.

20. Jul 29

    FDA authorizes Caristo's CaRi-Heart

    A De Novo authorization makes CaRi-Heart the first US-authorized technology to quantify coronary inflammation from routine coronary CT angiography, producing a fat-attenuation-index biomarker and a 10-year cardiac-risk score.