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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1272 devices
PhysCade System
PhysCade, Inc.
Sourced from FDA AI listRadiologySmile Dx®
Cube Click, Inc.
Sourced from FDA AI listRadiologySecond Opinion® BLE
Pearl Inc.
Sourced from FDA AI listlaboratory_medicineLensHooke X12 PRO Semen Analysis System
Bonraybio Co., LTD.
Sourced from FDA AI listRadiologySecond Opinion® Pediatric
Pearl, Inc.
Sourced from FDA AI listCardiologyAT-Patch (ATP-C130/ATP-C70)
ATsens Co.,Ltd.
Sourced from FDA AI listRadiologyAccuro 3S
Rivanna Medical, Inc.
Sourced from FDA AI listRadiologySCENARIA View Phase 5.0
FUJIFILM Corporation
Sourced from FDA AI listRadiology6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote S.p.A.
Sourced from FDA AI listRadiologyuCT ATLAS Astound with uWS-CT-Dual Energy Analysis; uCT ATLAS with uWS-CT-Dual Energy Analysis
Shanghai United Imaging Healthcare Co.,Ltd.
Sourced from FDA AI listRadiologyVscan Air
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyLung AI (LAI001)
Exo Inc
Sourced from FDA AI listOphthalmologyCLARUS (700)
Carl Zeiss Meditec, Inc.
Sourced from FDA AI listRadiologySpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option
Arineta Ltd.
Sourced from FDA AI listRadiologySecond Opinion Periapical Radiolucency Contours
Pearl Inc.
Sourced from FDA AI listRadiologyVersaViewer
GE Medical Systems SCS
Sourced from FDA AI listNeurologyCanvas Dx
Cognoa, Inc.
Sourced from FDA AI listRadiologyBunkerHill BMD
BunkerHill Health
Sourced from FDA AI listRadiologyuAngio AVIVA CX
Shanghai United Imaging Healthcare Co.,Ltd.
Sourced from FDA AI listCardiologyVitalRhythm
VitalConnect, Inc.
Sourced from FDA AI listRadiologyRayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3
RaySearch Laboratories AB (PUBL)
Sourced from FDA AI listRadiologyHi-D Imaging 4TAVR
Hi-D Imaging AG
Sourced from FDA AI listRadiologyTribusConnect
TribusMed Beheer BV
Sourced from FDA AI listRadiologyV5med Lung AI
V5med Inc.
Sourced from FDA AI listResults powered by Typesense.