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 1,304FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.

950 devices

Radiology

Aidoc

Aidoc Medical

CEFDATGA

Verified clinician reviews launching

Multi-condition CT triage platform (aiOS™) covering intracranial haemorrhage, pulmonary embolism, aortic dissection, large and medium vessel occlusion, cervical-spine fracture, rib fracture, pneumothorax, and further abdominal findings — surfaced as prioritised worklist flags to radiologists and emergency clinicians in real time.

Radiology

Lunit INSIGHT CXR

Lunit

CEFDA

Verified clinician reviews launching

AI for chest-X-ray abnormality detection covering 10 major findings including lung nodule, pneumothorax, pneumonia and pleural effusion with radiologist-level sensitivity.

Radiology

Viz.ai

Viz.ai

CEFDA

Verified clinician reviews launching

Care-coordination platform (Viz.ai One) that analyses imaging and other signals for time-critical findings — most prominently large-vessel occlusion (LVO) on CT angiography — and alerts the appropriate specialist on a mobile application in parallel to standard image interpretation. The suite has since expanded across stroke (LVO, perfusion, intracranial and subdural haemorrhage, aneurysm), vascular (abdominal aortic aneurysm, pulmonary embolism), and cardiac (AI-enabled ECG screening for hypertrophic cardiomyopathy) pathways.

Radiology

qXR

Qure.ai

CEFDAHCTGA

Verified clinician reviews launching

A deep-learning chest X-ray platform whose scope depends sharply on jurisdiction. The international, CE-marked product reads frontal chest radiographs for roughly 29-30 abnormality categories with heatmap localisation and a structured report. In the United States the brand exists only as a set of narrow, single-purpose clearances — breathing-tube position, pneumothorax/effusion triage, cardiothoracic-ratio measurement, lung-nodule computer-aided detection, and (from 2026) a multi-finding CADe device, qXR-Detect — each cleared for one task rather than the broad reporting tool sold elsewhere.

Radiology

ProFound AI for Digital Breast Tomosynthesis

iCAD (DeepHealth / RadNet)

CEFDAHC

Verified clinician reviews launching

Concurrent-read computer-aided detection for digital breast tomosynthesis (DBT). ProFound analyses every reconstructed tomosynthesis plane, marks suspicious soft-tissue densities and calcifications with a per-finding Certainty of Finding score, and assigns a per-case score reflecting the algorithm's overall suspicion for the study. It is an assistive overlay read alongside the radiologist, not an autonomous or triage device.

Radiology

Annalise CXR

Annalise.ai

CEFDATGA

Verified clinician reviews launching

Comprehensive chest X-ray AI that classifies up to 124 clinical findings simultaneously, with heatmap localisation and a radiologist-style structured report in its CE-marked decision-support form, and a five-finding triage-and-notification variant (Annalise Triage CXR) cleared in the United States for pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fracture.

Radiology

AI-Rad Companion Chest

Siemens Healthineers

Sourced from FDA AI listRadiology

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 listRadiology

SubtleMR

Subtle Medical

Editorial summaryRadiology

Veye Lung Nodules

Aidence (Deep Health)

Sourced from FDA AI listRadiology

LiverMultiScan

Perspectum

Sourced from FDA AI listRadiology

Automation Platform

Canon Medical Systems

Sourced from FDA AI listRadiology

ClearRead CT

Riverain Technologies

Sourced from FDA AI listRadiology

ClearRead X-ray

Riverain Technologies

Sourced from FDA AI listRadiology

Prognica DenseBreast AI

Prognica Labs

Sourced from FDA AI listRadiology

contextflow SEARCH

contextflow

Sourced from FDA AI listRadiology

MammoScreen® (4)

Therapixel

Sourced from FDA AI listRadiology

PIUR tUS inside

PIUR Imaging GmbH

Sourced from FDA AI listRadiology

RT 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 listRadiology

Brainlab 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 listRadiology

Second Opinion® 3D

Pearl, Inc.

Sourced from FDA AI listRadiology

Clarius Median Nerve AI

Clarius Mobile Health Corp.

Sourced from FDA AI list

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