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.

  1. Aidoc

    Aidoc Medical

    The most-deployed AI radiology platform in 2026 — multi-pathology CT triage with the longest production track record.

  2. CADDIE

    Olympus Corporation (Odin Medical Ltd.)

    First RCT-grade evidence in colonoscopy AI — the EAGLE 2026 trial.

  3. Caption AI

    GE HealthCare (Caption Health)

    Bringing point-of-care echocardiography to non-cardiologists. The first FDA-cleared assistive AI for image acquisition.

  4. HeartFlow FFRCT Analysis

    HeartFlow, Inc.

    Non-invasive coronary FFR. PMA-grade evidence accumulated over a decade of clinical use.

  5. LumineticsCore

    Digital Diagnostics (formerly IDx Technologies)

    First autonomous AI diagnostic ever cleared in the United States — diabetic retinopathy at the point of care.

  6. 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 1,272FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.

1272 devices

Neurology

e-Stroke Suite

Brainomix

CEFDA

Verified clinician reviews launching soon

AI imaging platform (Brainomix 360) for suspected acute ischaemic stroke, combining e-ASPECTS automated scoring of early ischaemic change on non-contrast CT, e-CTA large-vessel-occlusion detection and collateral scoring on CT angiography, and e-CTP core/penumbra estimation on CT perfusion — surfaced to stroke physicians and neuroradiologists as decision support across the hyperacute pathway.

Radiology

Veye Lung Nodules

Aidence B.V. (DeepHealth, a RadNet company)

CEFDA

Verified clinician reviews launching soon

Deep-learning software that automatically detects, measures, classifies and tracks pulmonary nodules on chest CT, including volume and volume-doubling time across serial scans. Veye runs as a concurrent or second reader — the radiologist reviews every finding — and a reporting add-on prepopulates the structured protocol used by the NHS England Targeted Lung Health Checks, where it is the lung-screening AI of choice. CE-marked Class IIb under the EU MDR; not FDA-cleared, and not distributed in the United States.

Neurology

Viz LVO

Viz.ai

Editorial summaryPathology

Paige Prostate Detect

Paige.AI

Editorial summaryOther

Sleep Apnea Notification Feature (SANF)

Apple Inc.

Editorial summaryObstetrics / Gynecology

CHLOE BLAST

Fairtility Ltd.

Editorial summaryPathology

ArteraAI Prostate

Artera Inc.

Editorial summaryPathology

X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application

Scopio Labs, Ltd.

Editorial summaryEmergency Medicine

TriVerity

Inflammatix, Inc.

Editorial summaryEndoscopy

Deep Capsule (Deep Capsule US)

DigestAID - Artificial Intelligence Development, S.A.

Editorial summaryNeurology

EarliPoint Assessment

EarliTec Diagnostics, Inc.

Editorial summaryCardiology

ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)

Anumana, Inc.

Editorial summaryOther

Tyto Insights for Eardrum Bulging Detection

Tyto Care, Ltd.

Editorial summaryEndoscopy

SKOUT system

Iterative Health

Editorial summaryUltrasound

Nerveblox

Smart Alfa Teknoloji San. Ve Tic. A.S.

Editorial summaryObstetrics / Gynecology

PeriCALM Patterns 3.0

PeriGen, Inc.

Editorial summaryNeurology

Ceribell Delirium Monitor System

Ceribell, Inc.

Editorial summaryEmergency Medicine

Sepsis ImmunoScore

Prenosis, Inc.

Editorial summaryOncology

Claire OCT System

Perimeter Medical Imaging AI, Inc.

Editorial summaryRadiology

BriefCase ICH

Aidoc Medical

Sourced from FDA AI listRadiology

BriefCase PE

Aidoc Medical

Sourced from FDA AI listRadiology

Incisive Smart Workflow

Philips

Sourced from FDA AI listUltrasound

Caption Interpretation

GE HealthCare (Caption Health)

Editorial summaryObstetrics / Gynecology

SonoCNS Fetal Brain

GE HealthCare

Sourced from FDA AI list

Results powered by Typesense.