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
OsteoSight Hip (v1)
Naitive Technologies Ltd
Sourced from FDA AI listRadiologyCogNet AI-MT+
Medcognetics, Inc.
Sourced from FDA AI listRadiologyScaida BrainCT-ICH (v1.0)
Mlhealth 360
Sourced from FDA AI listRadiologyTraumaCad Neo (1.1)
Brainlab Ltd.
Sourced from FDA AI listRadiologysyngo.CT LVO Detection
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologySubtleHD (1.x)
Subtle Medical, Inc.
Sourced from FDA AI listRadiologyBioTraceIO Vision (V1.7)
Techsomed Medical Technologies
Sourced from FDA AI listCardiologyECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010)
Anumana, Inc.
Sourced from FDA AI listRadiologySynapse PACS (7.5)
FUJIFILM Healthcare Americas Corporation
Sourced from FDA AI listNeurologyTMINI Miniature Robotic System
THINK Surgical, Inc.
Sourced from FDA AI listRadiologyCirrus Resting State fMRI Software
Sora Neuroscience, Inc.
Sourced from FDA AI listRadiologyLARALAB
LARALAB GmbH
Sourced from FDA AI listRadiologyCleerly LABS (v2.0)
Cleerly, Inc.
Sourced from FDA AI listRadiologyEFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100)
Ever Fortune.AI, Co., Ltd.
Sourced from FDA AI listRadiologycmAngio® (V1.6)
CureMetrix, Inc.
Sourced from FDA AI listRadiologyContour ProtégéAI+
MIM Software Inc.
Sourced from FDA AI listRadiologyIRISeg
Intuitive Surgical Inc.
Sourced from FDA AI listRadiologyLungVision
BodyVision Medical Ltd.
Sourced from FDA AI listgastroenterology_urologyGI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
Cosmo Artificial Intelligence - AI Ltd
Sourced from FDA AI listCardiologyCorVista System with PH Add-On
Analytics for Life, Inc.
Sourced from FDA AI listOtherSepsis ImmunoScore
Prenosis, Inc.
Sourced from FDA AI listRadiologyTumorSight Viz
SimBioSys, Inc.
Sourced from FDA AI listRadiologyAudaxCeph Cephalogram Analysis Software
Audax d.o.o.
Sourced from FDA AI listNeurologyautoSCORE (V 2.0.0)
Holberg EEG AS
Sourced from FDA AI listResults powered by Typesense.