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
Prognica DenseBreast AI
Prognica Labs
Sourced from FDA AI listRadiation OncologyDLCExpert
Mirada Medical
Sourced from FDA AI listOncologyFlywheel Oncology Planner
Flywheel
Sourced from FDA AI listRadiologycontextflow SEARCH
contextflow
Sourced from FDA AI listDermatologyNia Eczema Coach
Nia Health
Sourced from FDA AI listPrimary CareBabylon Symptom Checker
eMed / Babylon Health
Sourced from FDA AI listObstetrics / GynecologyCHLOE BLAST
Fairtility Ltd.
Sourced from FDA AI listPathologyArteraAI Prostate
Artera Inc.
Sourced from FDA AI listRadiologyMammoScreen® (4)
Therapixel
Sourced from FDA AI listRadiologyPIUR tUS inside
PIUR Imaging GmbH
Sourced from FDA AI listRadiologyRT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RT
Brainlab AG
Sourced from FDA AI listRadiologyBrainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)
Brainlab AG
Sourced from FDA AI listRadiologySecond Opinion® 3D
Pearl, Inc.
Sourced from FDA AI listRadiologyClarius Median Nerve AI
Clarius Mobile Health Corp.
Sourced from FDA AI listRadiologyAnnalise Enterprise
Annalise-AI
Sourced from FDA AI listanesthesiologyTyto Insights for Rhonchi Detection
Tyto Care , Ltd.
Sourced from FDA AI listRadiologyMR Contour DL
GE HealthCare
Sourced from FDA AI listRadiologyRayvolve PTX-PE
AZmed
Sourced from FDA AI listRadiologyLVivo Seamless
DiA Imaging Analysis Ltd.
Sourced from FDA AI listRadiologyVentripoint Medical System Plus (VMS+) 4.0
Ventripoint Diagnostics Ltd.
Sourced from FDA AI listRadiologyOncoStudio (OS-01)
OncoSoft. Co., Ltd.
Sourced from FDA AI listRadiologyTranspara (2.1.0)
ScreenPoint Medical B.V.
Sourced from FDA AI listRadiologySaige-Dx
DeepHealth, Inc
Sourced from FDA AI listRadiologyProFound Detection (V4.0)
iCAD, Inc.
Sourced from FDA AI listResults powered by Typesense.