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.

1304 devices

Pathology

Paige Prostate Detect

Paige.AI (acquired by Tempus AI, August 2025)

CEFDAUKCA

Verified clinician reviews launching

Deep-learning software that analyses digitised whole slide images (WSI) of prostate needle core biopsies to detect foci suspicious for cancer and pinpoint — via a single X/Y coordinate — the site of highest malignancy probability for pathologist review. The algorithm operates as a second-read overlay within a digital pathology workflow; it does not render a standalone diagnosis.

Ophthalmology

LumineticsCore

Digital Diagnostics (formerly IDx Technologies)

CEFDA

Verified clinician reviews launching

Autonomous deep-learning software that analyses retinal fundus images acquired with a Topcon TRC-NW400 non-mydriatic camera to detect more-than-mild diabetic retinopathy (mtmDR) and clinically significant diabetic macular edema — and issues a binary refer/rescreen result without any physician or optometrist interpreting the image. The algorithm is the first and, to date, only FDA-cleared AI medical device operating entirely without a human-in-the-loop diagnostic step.

Cardiology

HeartFlow FFRCT Analysis

HeartFlow, Inc.

CEFDAUKCA

Verified clinician reviews launching

Patient-specific 3-D computational fluid dynamics model of the coronary circulation, derived from standard coronary CT angiography (CCTA) DICOM data, that yields a colour-coded fractional flow reserve (FFRCT) map across the coronary tree — enabling non-invasive, lesion-level physiological assessment of haemodynamically significant stenosis without adenosine stress or invasive catheterisation.

Cardiology

Caption AI

GE HealthCare (Caption Health)

CEFDAHCTGA

Verified clinician reviews launching

Real-time deep-learning guidance that coaches any clinician through the 10 standard transthoracic echocardiographic views — providing over 90 types of probe-movement instructions and a live Quality Meter — enabling nurses and non-sonographers to acquire diagnostic-quality cardiac ultrasound studies without prior echocardiography training.

Endoscopy

CADDIE

Olympus Corporation (Odin Medical Ltd.)

CEFDA

Verified clinician reviews launching

Real-time cloud-based computer-aided detection (CADe) of suspected colorectal polyps during white-light colonoscopy, delivering visual bounding-box alerts to the endoscopist without altering the endoscope hardware.

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.

Cardiology

EchoGo Heart Failure

Ultromics

CEFDAUKCA

Verified clinician reviews launching

Cloud-based echocardiography AI that auto-calculates ejection fraction and detects heart-failure with preserved ejection fraction (HFpEF) from a single apical four-chamber view.

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.

Neurology

qER

Qure.ai

CEFDAHC

Verified clinician reviews launching

Deep-learning triage software for non-contrast adult head CT. The US-cleared qER configuration analyses scans in the background and raises a case-level worklist flag for suspected intracranial haemorrhage, mass effect, midline shift and cranial fracture; a sibling clearance (qER-Quant) adds quantitative brain-structure measurement, and a 2025 clearance (qER-CTA) extends triage to suspected large-vessel occlusion on CT angiography. The triage device is notification-only: it does not mark the image or render a diagnosis.

Pathology

PathAI Platform

PathAI

CEFDA

Verified clinician reviews launching

End-to-end digital pathology platform combining an AI-powered image management system (AISight) with research-use AI algorithms for oncology, NASH and inflammatory disease.

Neurology

icobrain

icometrix (a GE HealthCare company)

CEFDA

Verified clinician reviews launching

A family of quantitative brain-imaging modules that automatically segment and measure clinically relevant brain structures and lesions from routine DICOM studies — whole-brain, hippocampal and ventricular volumes and longitudinal change on MRI for dementia, multiple sclerosis and epilepsy; hyperdense haemorrhage volume, cisternal compression and midline shift on non-contrast head CT for traumatic brain injury; and perfusion mapping on CT perfusion. A separate cleared module, icobrain aria, is a computer-aided detection and diagnosis tool that detects, measures and grades amyloid-related imaging abnormalities (ARIA-E and ARIA-H) in patients on amyloid-targeting Alzheimer's therapies. Every module is a concurrent reading aid, not an autonomous reader.

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.

Pathology

Galen Prostate / Galen Breast

Ibex Medical Analytics

CEFDA

Verified clinician reviews launching

AI for cancer detection and grading in digitised whole-slide images of needle-core biopsies. The Galen Prostate algorithm detects cancer, assigns Gleason grade, flags perineural invasion and estimates tumour size; sibling modules cover breast and gastric tissue and HER2 IHC scoring. In the US, the FDA-cleared product (Ibex Prostate Detect, formerly Galen Second Read) operates strictly as a parallel second-read alert tool; the broader First Read and non-prostate modules are CE-marked or research-use, not FDA-cleared.

Orthopedics

BoneView

Gleamer

CEFDAUKCA

Verified clinician reviews launching

AI that detects acute fractures on adult and pediatric musculoskeletal X-rays, covering limbs, pelvis, thoracic cage and spine.

Ophthalmology

EyeArt

Eyenuk

CEFDA

Verified clinician reviews launching

Autonomous AI system that analyses color fundus images to detect more-than-mild and vision-threatening diabetic retinopathy at the point of care.

Cardiology

Cleerly Coronary Analysis

Cleerly

FDA

Verified clinician reviews launching

AI-based analysis of coronary CT angiograms quantifying plaque burden, plaque composition and stenosis severity to produce a personalized heart-disease risk profile.

Ultrasound

Butterfly iQ+ with AI

Butterfly Network

CEFDA

Verified clinician reviews launching

Single-probe handheld point-of-care ultrasound paired with AI modules for bladder-volume estimation, auto ejection-fraction and lung-artefact classification.

Neurology

e-Stroke Suite

Brainomix

CEFDA

Verified clinician reviews launching

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.

Cardiology

Cardio AI (Tempus Pixel Cardio)

Arterys (Tempus AI)

CEFDAHC

Verified clinician reviews launching

Cloud-native cardiac MRI post-processing that automates ventricular segmentation and function quantification — biventricular volumes, ejection fraction, mass and, in later versions, flow and tissue-characterisation maps. The deep-learning contours are editable: the software proposes measurements that the reading clinician reviews and corrects, so it is decision-support rather than an autonomous reader. Now marketed under Tempus as Tempus Pixel Cardio, with Arterys Inc. remaining the FDA applicant of record.

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.

Neurology

Viz LVO

Viz.ai

Editorial summaryPathology

Paige Prostate Detect

Paige.AI

Editorial summary

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