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 1,358FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.
1358 devices
Spine Auto Views
GE Medical Systems SCS
Sourced from FDA AI listNeurologyCranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Brainlab AG
Sourced from FDA AI listRadiologyuSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super
Wuhan United Imaging Healthcare Co.,Ltd
Sourced from FDA AI listRadiologyuOmnispace
Shanghai United Imaging Healthcare Co., Ltd
Sourced from FDA AI listCardiologyAusculThing ACC
AusculThing Oy
Sourced from FDA AI listRadiologyCAC Software
Imbio, Inc.
Sourced from FDA AI listRadiologySonic DL
GE Medical Systems,LLC (GE Healthcare)
Sourced from FDA AI listRadiologySenographe Pristina 3D
GE Healthcare
Sourced from FDA AI listRadiologyAutoplaque
Cedars-Sinai Medical Center: AIM
Sourced from FDA AI listRadiologySurgical Reality Viewer
Medicalvr B.V.
Sourced from FDA AI listRadiologyMR DWI/FLAIR Measurement V1.0
Olea Medical
Sourced from FDA AI listRadiologyiCAC Device
Bunkerhill, Inc
Sourced from FDA AI listRadiologyQuantib Prostate
Quantib BV
Sourced from FDA AI listanesthesiologyCapnostream35 Portable Respiratory Monitor (PM35MN)
Covidien, LLC
Sourced from FDA AI listOrthopedicsVeritas Reverse Total Shoulder System
Restor3D
Sourced from FDA AI listCardiologyDeepRhythmAI
Medicalgorithmics S.A.
Sourced from FDA AI listRadiologyPrecision DL
GE Healthcare
Sourced from FDA AI listCardiologyLINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application
Medtronic, Inc.
Sourced from FDA AI listRadiologySwoop® Portable MR Imaging® System
Hyperfine, Inc.
Sourced from FDA AI listRadiologyRayStation 12A
RaySearch Laboratories AB (publ)
Sourced from FDA AI listRadiologyFlightPlan for Embolization
GE Medical Systems SCS
Sourced from FDA AI listRadiologyHERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyMonaco RTP System (6.3)
Elekta Solutions AB
Sourced from FDA AI listCardiologyReveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System
Medtronic, Inc.
Sourced from FDA AI listResults powered by Typesense.