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
HS40 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listNeurologySafeOp 3: Neural Informatix System
Alphatec Spine, Inc.
Sourced from FDA AI listRadiologyVivid E80, Vivid E90, Vivid E95
GE Medical Systems Ultrasound and
Sourced from FDA AI listRadiologysyngo.CT Extended Functionality
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVenue
GE Medical Systems
Sourced from FDA AI listRadiologyVenue Fit
GE Medical Systems
Sourced from FDA AI listRadiologyDeepBT Detector-Plus
Aitewan Biomedical Technology, Inc.
Sourced from FDA AI listRadiologyVenue Go
GE Medical Systems Ultrasound and Primary Care Diagnostics
Sourced from FDA AI listRadiologyVivid T8, Vivid T9
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologyVivid iq
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC
Sourced from FDA AI listOphthalmologyIDx-DR v2.3
Digital Diagnostics Inc.
Sourced from FDA AI listRadiologyVivid S60N, Vivid S70N
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologyMAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A
Siemens Medical Solutions USA Inc.
Sourced from FDA AI listRadiologyEMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
Elekta Solutions AB
Sourced from FDA AI listRadiologyMyomics
Phantomics Inc.
Sourced from FDA AI listRadiologyV8 Diagnostic Ultrasound System; cV8 Diagnostic Ultrasound System; V7 Diagnostic Ultrasound System; cV7 Diagnostic Ultrasound System; V6 Diagnostic Ultrasound System; cV6 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.
Sourced from FDA AI listRadiologyAIR Recon DL
GE Medical Systems,LLC (GE Healthcare)
Sourced from FDA AI listRadiologysyngo.CT CaScoring
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listCardiologyeMurmur Heart AI
CSD Labs GmbH
Sourced from FDA AI listRadiologyMAGNETOM Skyra Fit
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyVersana Balance
GE Medical Systems Ultrasound and Primary Care Diagnostics,
Sourced from FDA AI listRadiologySegment 3DPrint
Medviso AB
Sourced from FDA AI listRadiologyaPROMISE X
EXINI Diagnostics AB
Sourced from FDA AI listRadiologyPhilips Incisive CT
Philips Healthcare (Suzhou) Co., Ltd.
Sourced from FDA AI listResults powered by Typesense.