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
AIAS Cephalon
Metamorphosis GmbH
Sourced from FDA AI listRadiologyOTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
Perimeter Medical Imaging AI, Inc.
Sourced from FDA AI listRadiologyLungQ 4
Thirona BV
Sourced from FDA AI listRadiologyInferOperate Suite
Beijing Infervision Healthcare Medical Technology Co., Ltd.
Sourced from FDA AI listRadiologyFETOLY
Diagnoly
Sourced from FDA AI listRadiologySIGNA Sprint
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyMuscleView 2.0
Springbok, Inc. (dba Springbok Analytics)
Sourced from FDA AI listRadiologyVidea Dental AI
VideaHealth Inc.
Sourced from FDA AI listCardiologyBunkerhill ECG-EF
BunkerHill Health
Sourced from FDA AI listCardiologyAssert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)
Abbott
Sourced from FDA AI listRadiologyECHELON Synergy
Fujifilm Corporation
Sourced from FDA AI listRadiologyuDR Aurora CX
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listCardiologyVolta AF-Xplorer II
Volta Medical
Sourced from FDA AI listRadiologySurgiTwin
Twinsight
Sourced from FDA AI listRadiologySonosite LX and Sonosite PX Ultrasound Systems
Fujifilm Sonosite Inc
Sourced from FDA AI listRadiologyNeurophet AQUA
Neurophet., Inc.
Sourced from FDA AI listRadiologyDose+ (1.0)
Mvision AI Oy
Sourced from FDA AI listRadiologyPRAEVAorta®2
Nurea
Sourced from FDA AI listRadiologyDefinium Tempo Select
GE Hualun Medical Systems Co., Ltd
Sourced from FDA AI listRadiologyVista OS, Vista AI Scan, RTHawk
Vista AI, Inc.
Sourced from FDA AI listRadiologyVenue; Venue Go; Venue Fit; Venue Sprint
GE Medical Systems Ultrasound and Primary care Diagnostics,
Sourced from FDA AI listRadiologyDS Core Diagnosis
Dentsply Sirona Inc.
Sourced from FDA AI listRadiologyEPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
Philips Ultrasound LLC
Sourced from FDA AI listRadiologyuMR Jupiter
Shanghai United Imaging Healthcare Co., Ltd.
Sourced from FDA AI listResults powered by Typesense.