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
EASYCELL CELL LOCATOR
MEDICA CORP.
Sourced from FDA AI listanesthesiologySLEEP SYSTEM FOR CLINICS & RESEARCH
COMPUMEDICS PTD LTD.
Sourced from FDA AI listRadiologyLOGICON CARIES DETECTOR
CARESTREAM DENTAL LLC
Sourced from FDA AI listRadiologyUltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program
Canon Medical Systems Corporation
Sourced from FDA AI listCardiologyAlio
Alio, Inc.
Sourced from FDA AI listRadiologyMRI Planner
Spectronic Medical AB
Sourced from FDA AI listlaboratory_medicineCELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER
CELLAVISION AB
Sourced from FDA AI listRadiologySECOND LOOK ™
ICAD, INC.
Sourced from FDA AI listRadiologyRAPIDSCREEN RS-2000
RIVERAIN MEDICAL GROUP
Sourced from FDA AI listRadiologyM1000 IMAGECHECKER
Hologic, Inc.
Sourced from FDA AI listPathologyPAPNET Testing System
Neuromedical Systems, Inc.
Sourced from FDA AI listRadiologyIngenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems
Philips Medical Systems Nederland B.V.
Sourced from FDA AI listRadiologySwiftSight-Brain
AIRS Medical Inc.
Sourced from FDA AI listlaboratory_medicineDIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
CELLAVISION AB
Sourced from FDA AI listResults powered by Typesense.