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
InferRead CT Stroke.AI
Infervision Medical Technology Co., Ltd.
Sourced from FDA AI listRadiologyCINA CHEST
Avicenna.AI
Sourced from FDA AI listRadiologyMEDO-Thyroid
MEDO DX Pte. Ltd.
Sourced from FDA AI listlaboratory_medicinePhenoMATRIX
Copan Wasp Srl
Sourced from FDA AI listRadiologyViz RV/LV
Viz.ai, Inc.
Sourced from FDA AI listRadiologyRapid PE Triage and Notification (PETN)
iSchemaView Inc.
Sourced from FDA AI listRadiologyContour ProtegeAI
MIM Software Inc.
Sourced from FDA AI listRadiologyAV Vascular
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologyTOMTEC-ARENA
TOMTEC Imaging Systems GmbH
Sourced from FDA AI listRadiologyStrokeSENS LVO
Circle Neurovascular Imaging, Inc
Sourced from FDA AI listRadiologyOPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
Abbott Medical
Sourced from FDA AI listRadiologyProFound AI Software V3.0
iCAD Inc.
Sourced from FDA AI listRadiologysyngo.via MI Workflows, syngo MBF
Siemens Medical Solutions USA, Inc.
Sourced from FDA AI listRadiologyRapid ASPECTS
iSchemaView Inc.
Sourced from FDA AI listRadiologyEchoGo Core
Ultromics Ltd
Sourced from FDA AI listRadiologyCritical Care Suite with Endotracheal Tube Positing AI algorithm
GE Medical Systems, LLC
Sourced from FDA AI listRadiologyPowerLook Density Assessment V4.0
iCAD, Inc.
Sourced from FDA AI listRadiologySaige-Q
DeepHealth, Inc.
Sourced from FDA AI listRadiologyViz ICH
Viz.ai, Inc.
Sourced from FDA AI listlaboratory_medicineAccelerate Pheno System, Accelerate PhenoTest BC Kit
Accelerate Diagnostics, Inc.
Sourced from FDA AI listRadiologyHealthMammo
Zebra Medical Vision Ltd.
Sourced from FDA AI listRadiologyNinesAI
Nines, Inc.
Sourced from FDA AI listCardiologySOZO
ImpediMed Limited
Sourced from FDA AI listNeurologyEYE-SYNC
SyncThink, Inc.
Sourced from FDA AI listResults powered by Typesense.