AI medical devices
A neutral, evidence-based catalogue. No manufacturer pricing, no buy links — just regulatory facts and clinical capability summaries.
Editor's Picks
The devices we'd point a colleague to first.
Aidoc
Aidoc Medical
The most-deployed AI radiology platform in 2026 — multi-pathology CT triage with the longest production track record.
CADDIE
Olympus Corporation (Odin Medical Ltd.)
First RCT-grade evidence in colonoscopy AI — the EAGLE 2026 trial.
Caption AI
GE HealthCare (Caption Health)
Bringing point-of-care echocardiography to non-cardiologists. The first FDA-cleared assistive AI for image acquisition.
HeartFlow FFRCT Analysis
HeartFlow, Inc.
Non-invasive coronary FFR. PMA-grade evidence accumulated over a decade of clinical use.
LumineticsCore
Digital Diagnostics (formerly IDx Technologies)
First autonomous AI diagnostic ever cleared in the United States — diabetic retinopathy at the point of care.
Paige Prostate Detect
Paige.AI (acquired by Tempus AI, August 2025)
First FDA-authorized pathology AI — and a study reference for what "computer-aided" means in 2026 practice.
Of 1,304FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1304 devices
GI Genius
Medtronic (Cosmo Pharmaceuticals)
Sourced from FDA AI listRadiologyAI-Rad Companion Chest
Siemens Healthineers
Sourced from FDA AI listRadiation OncologyEthos Adaptive Therapy
Varian (Siemens Healthineers)
Editorial summaryDermatologyDERM
Skin Analytics
Editorial summaryRadiologyBriefCase ICH
Aidoc Medical
Sourced from FDA AI listRadiologyBriefCase PE
Aidoc Medical
Sourced from FDA AI listRadiologyIncisive Smart Workflow
Philips
Sourced from FDA AI listObstetrics / GynecologySonio Detect
Sonio
Editorial summaryUltrasoundCaption Interpretation
GE HealthCare (Caption Health)
Editorial summaryObstetrics / GynecologySonoCNS Fetal Brain
GE HealthCare
Sourced from FDA AI listRadiologySubtleMR
Subtle Medical
Editorial summaryRadiologyVeye Lung Nodules
Aidence (Deep Health)
Sourced from FDA AI listOphthalmologyEyeLook Glaucoma
Digital Diagnostics
Sourced from FDA AI listRadiation OncologyRayStation Deep Learning Segmentation
RaySearch Laboratories
Editorial summaryEndoscopyCADU
Olympus Corporation (Odin Medical Ltd.)
Editorial summaryRadiologyLiverMultiScan
Perspectum
Sourced from FDA AI listEndoscopySMARTIBD
Olympus Corporation (Odin Medical Ltd.)
Editorial summaryRadiologyAutomation Platform
Canon Medical Systems
Sourced from FDA AI listOphthalmologyOptomed Aurora IQ
Optomed
Editorial summaryPrimary CareAda Assessment Platform
Ada Health
Sourced from FDA AI listRadiologyClearRead CT
Riverain Technologies
Sourced from FDA AI listOphthalmologyRetinAI Discovery
RetinAI Medical
Sourced from FDA AI listDermatologyDermEngine
MetaOptima Technology
Editorial summaryRadiologyClearRead X-ray
Riverain Technologies
Sourced from FDA AI listResults powered by Typesense.