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
BrainInsight
Hyperfine, Inc.
Sourced from FDA AI listRadiologyMerge PACS
Merge Healthcare Incorporated
Sourced from FDA AI listRadiologyRapid NCCT Stroke
iSchemaView, Inc.
Sourced from FDA AI listRadiologyCaption Interpretation Automated Ejection Fraction Software
Caption Health, Inc
Sourced from FDA AI listRadiologyCINA
AVICENNA.AI
Sourced from FDA AI listRadiologyViz SDH
Viz.ai, Inc.
Sourced from FDA AI listRadiologyAVIEW
Coreline Soft Co.,Ltd.
Sourced from FDA AI listNeurologySense System with IBT Electrodes
Infinite Biomedical Technologies, LLC
Sourced from FDA AI listRadiologyAcorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak Medical
Sourced from FDA AI listCardiologyEko Analysis Software
Eko Devices Inc
Sourced from FDA AI listRadiologyCS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
Omega Medical Imaging, LLC
Sourced from FDA AI listRadiologyAI-Rad Companion Organs RT
Siemens Medical Solutions USA, Inc
Sourced from FDA AI listRadiologyCogNet QmTRIAGE
MedCognetics, Inc.
Sourced from FDA AI listlaboratory_medicineAPAS Independence with Urine Analysis Module
Clever Culture Systems AG
Sourced from FDA AI listRadiologyPowerLook® Tomo Detection Software
iCAD Inc
Sourced from FDA AI listRadiologySIGNA Artist Evo
GE Healthcare(Tianjin) Company Limited
Sourced from FDA AI listRadiologyDeepXray
Alpha Intelligence Manifolds, Inc.
Sourced from FDA AI listRadiologyEPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System
Philips Ultrasound, Inc.
Sourced from FDA AI listNeurology7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
7D Surgical Inc.
Sourced from FDA AI listRadiologyScreenDx
Imvaria, Inc
Sourced from FDA AI listRadiologyBrainomix 360 e-CTA
Brainomix Limited
Sourced from FDA AI listRadiologySaige-Density (2.5.0)
DeepHealth, Inc
Sourced from FDA AI listRadiologyPhilips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
Philips Medical Systems
Sourced from FDA AI listRadiologyClearPoint Maestro Brain Model
ClearPoint Neuro, Inc.
Sourced from FDA AI listResults powered by Typesense.