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 1,358FDA-cleared AI medical devices, roughly three quarters are radiology — the field's regulatory pioneer. The catalogue is filterable by specialty below.

1358 devices

Orthopedics

BoneView

Gleamer

CEFDAHC

Deep-learning decision support that flags acute fractures on musculoskeletal trauma radiographs, marking suspicious regions for the reading clinician. In the United States the cleared use is fracture detection: in adults across the limbs, pelvis, rib cage and dorsolumbar spine, and — since a 2023 clearance — in children aged two and older on limb radiographs. The wider CE-marked product additionally reports dislocations, elbow joint effusions and focal bone lesions, a broader scope than the US label carries.

Radiology

Annalise CXR

Annalise.ai

CEFDATGA

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.

Primary Care

Ada

Ada Health GmbH

CE

An AI symptom-assessment and triage system delivered as two related products: a widely used consumer smartphone app and "Ada Assess," an enterprise, clinician- and partner-facing version. A user answers an adaptive series of questions about their symptoms; a probabilistic reasoning engine, running over a medical knowledge base curated by Ada's physicians, then suggests possible conditions and an urgency level — from self-care through to emergency — to guide where and how soon to seek care. It is explicitly care-navigation and triage support, not a diagnosis: the consumer app operates without a clinician in the loop and does not, and in the United States is not authorised to, provide a medical diagnosis or clinical decision support. The regulated medical-device status attaches to Ada Assess (CE Class IIa under EU MDR); the consumer app's exact class is described inconsistently across the company's own materials.

Radiology

ProFound AI for Digital Breast Tomosynthesis

iCAD (DeepHealth / RadNet)

CEFDAHC

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.

Radiation Oncology

Ethos

Varian (a Siemens Healthineers company)

CEFDA

AI-driven online adaptive radiotherapy: a ring-gantry treatment system whose software re-contours the patient's anatomy from the day's cone-beam CT while the patient lies on the couch, regenerates the treatment plan against that anatomy, and offers the clinician a side-by-side choice between the original scheduled plan and the freshly adapted one — inside a single treatment slot. Deep-learning segmentation produces the anchor structures that drive the adaptation; an automated optimisation engine rebuilds the dose plan. Where most devices in this catalogue read images, Ethos closes the loop from image to re-planned treatment, which is why its clearances cover a therapy system and its planning software rather than an analysis tool.

Dermatology

DermEngine

MetaOptima Technology

CETGA

An intelligent dermatology platform that combines a teledermatology and total-body-photography workflow with AI analysis of skin lesions. Its signature AI feature is "Visual Search" — content-based image retrieval that, given a dermoscopic or clinical photograph, returns visually similar catalogued lesions and their diagnoses as a differential aid — alongside a lesion-classification and melanoma-risk model. Images are captured on a smartphone through the paired MoleScope dermatoscope or the OptimaScan device. Two points define the platform honestly: the AI is assistive decision support, never an autonomous diagnosis, and the diagnostic AI itself carries no regulatory clearance in any jurisdiction — the cleared and registered items are the dermatoscope hardware, not the algorithm.

Cardiology

Cleerly Coronary Analysis

Cleerly, Inc.

CEFDAUKCA

Analysis of coronary CT angiograms that segments and quantifies atherosclerotic plaque — total volume, per-vessel burden and composition (calcified, non-calcified, low-attenuation) — grades stenosis, and, in the ISCHEMIA module, predicts the vessel-level functional significance of a lesion. The FDA has cleared two distinct products under this line: Cleerly Labs (plaque and stenosis quantification) and Cleerly ISCHEMIA (a machine-learned ischaemia estimate). Four US 510(k) clearances; no CE mark or other international authorisation was verifiable in this review.

Ophthalmology

AEYE-DS

AEYE Health, Inc.

FDA

Software-only autonomous AI that reads a single retinal image per eye and returns a binary more-than-mild diabetic-retinopathy result without any clinician interpreting the image. AEYE-DS is the third autonomous diabetic-retinopathy AI cleared in the United States, after LumineticsCore (2018) and EyeArt (2020), and the first cleared to run on a handheld fundus camera as well as a desktop one. Its distinguishing design choice is economy of input: one non-mydriatic image per eye rather than the multi-field protocols its predecessors were validated on, which its pivotal data suggest most patients can provide without pupil dilation. The algorithm is legally held by AEYE Health and is cleared as a device in its own right, separate from the cameras it pairs with.

Cardiology

EchoGo Heart Failure

Ultromics

CEFDAUKCA

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.

Neurology

Viz LVO

Viz.ai

Editorial summaryPathology

Paige Prostate Detect

Paige.AI

Editorial summaryOrthopedics

UNiD Spine Analyzer

Medicrea International S.A.S. (Medtronic)

Editorial summaryPrimary Care

Tyto Insights for Wheeze Detection

Tyto Care, Ltd.

Editorial summaryOther

CephX3D

Orca Dental AI, Ltd.

Editorial summaryDermatology

DeepView AI System

Spectral MD, Inc.

Editorial summaryOncology

HistoSonics Planning Tool

HistoSonics, Inc.

Editorial summaryCardiology

EchoNext

Pathwai, Inc.

Editorial summaryRadiation Oncology

RadOncAI

InformAI, Inc.

Editorial summaryOther

SurgiCount+ System

Stryker Instruments

Editorial summaryOther

Personalized Therapy Comfort Settings (PTCS)

ResMed Corp

Editorial summaryOrthopedics

OrthoGrid Hip AI 4.0

OrthoGrid Systems, Inc.

Editorial summaryEmergency Medicine

Bayesian Health Sepsis Flagging Device

Bayesian Health, Inc.

Editorial summaryNeurology

SOMNUM

Honeynaps Co., Ltd.

Editorial summaryObstetrics / Gynecology

Embryo Predict

Alife Health

Editorial summary

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