AI Medical Device Use-Case Index

Easee Ocular is a CE-marked (EU MDR, Class IIa) cloud-based eye-exam platform — noted as one of the first CE-certified at-home, AI-supported vision tests. It measures visual acuity and refraction through a web browser, demonstrating comparability to conventional refraction so patients can obtain a validated refraction remotely.

Us2.ai is a CE-marked (EU MDR, Class IIb) and FDA-cleared echocardiography AI from Singapore (founded as eko.ai). It delivers fully automated, guideline-directed echo analysis with 45+ measurements and disease-detection features for heart failure, aortic stenosis, cardiac amyloidosis and pulmonary hypertension, producing a complete structured report with minimal manual input.

The Virtual Nodule Clinic, from Oxford-based Optellum, was the first lung-cancer decision-support system cleared under EU MDR (also FDA-cleared and UKCA-marked). Its Lung Cancer Prediction AI analyses chest CT scans to produce a malignancy risk score for indeterminate lung nodules, helping clinicians stratify risk and accelerate early diagnosis and treatment.

mdbrain is a CE-marked (EU MDR, Class IIa) brain MRI solution from German company mediaire. It automatically labels, visualizes and quantifies brain structures and lesions, offering modules for volumetry, lesion characterization, aneurysm detection and tumor differentiation, and outputs structured reports with colour-coded deviations from normal reference values.

icobrain mr is a CE-marked (EU MDR, Class IIa) and FDA-cleared brain MRI solution from Belgian company icometrix (now part of GE HealthCare). It automatically segments and quantifies brain structures and lesions, giving radiologists and neurologists reproducible volumetric measures to track disease activity in MS, dementia and other neurological conditions.

ChestLink, from Lithuanian company Oxipit (acquired by Sectra in 2026), holds the world's first CE Class IIb certification (EU MDR) for fully autonomous AI medical imaging. It automatically identifies high-confidence normal chest X-rays and finalizes their reports without a radiologist, clearing routine 'normal' studies from the worklist so clinicians focus on abnormal cases.

Annalise Enterprise CXR is a CE-marked (EU MDR, Class IIb) decision-support solution from Annalise.ai (a Harrison.ai company). It is among the most comprehensive chest X-ray AIs, detecting up to 124 findings plus suspected TB in under 20 seconds and marking critical or unremarkable cases to streamline reporting. FDA clearances in the US cover a smaller subset of triage findings.

qXR is a CE-marked (EU MDR, Class IIb) chest X-ray AI from Qure.ai, trained on millions of radiographs. It detects and localizes a broad range of chest abnormalities, screens for tuberculosis and lung nodules, and triages normal vs abnormal films to prioritize the reporting worklist. It is WHO-evaluated for TB screening and FDA 510(k) cleared for selected indications.

Rayvolve is a CE-marked (EU MDR 2017/745, Class IIa) computer-assisted detection and diagnosis device from AZmed. It assists radiologists and emergency physicians by detecting and localizing fractures and abnormalities on standard X-rays, reducing missed findings and interpretation time. It is also FDA 510(k) cleared in the US.

BoneView is a CE-marked (EU MDR, Class IIa) computer-aided detection tool from French MedTech Gleamer. It analyses plain radiographs to detect fractures, joint effusions, dislocations and bone lesions, highlighting regions of interest as a second reader. It is one of the most clinically validated fracture-detection AIs and also holds FDA clearance for adult and paediatric use.

IDx-DR is an autonomous AI diagnostic system that analyses colour fundus photographs to detect more than mild / referable diabetic retinopathy and diabetic macular edema. In 2018 it became the first fully autonomous AI system authorised by the FDA (De Novo) to provide a diagnostic result without a clinician interpreting the image. In Europe it is certified as a Class IIa device under the EU MDR for diagnostic software. The product was renamed LumineticsCore in 2023.

CXR-AID is designed to better detect major abnormal findings such as chest nodule, consolidation, and pneumothorax from chest X-ray images. Findings detected by the AI software are shown in color as a heatmap display, with each score included. Through this solution, doctors and medical professionals are able to reduce missed cases and effectively diagnose chest diseases from chest X-ray.