AI Medical Device Use-Case Index

Legit.Health, a Spanish company, is a CE-marked (EU MDR, Class IIb) dermatology decision-support device. Its deep-learning algorithms recognize around 300 skin conditions — spanning malignant, inflammatory, infectious and autoimmune diseases — to support differential diagnosis, and automatically quantify disease severity using internationally recognized scoring systems from clinical images.

Aidoc, an Israeli medical-AI company, provides CE-marked (EU MDR) computer-aided triage software. Its flagship BriefCase ICH solution analyses non-contrast head CT scans and flags suspected intracranial hemorrhage, alerting clinicians and prioritizing the worklist so critical cases are reviewed sooner. Aidoc holds multiple CE-marked and FDA-cleared triage indications.

cvi42, from Circle Cardiovascular Imaging (Canada), is a CE-marked (EU MDR) cardiovascular image post-processing platform with AI-based automatic contouring. It quantifies cardiac function (ejection fraction, stroke volume, mass), blood flow and myocardial tissue characteristics from cardiac MRI and CT, giving cardiologists reproducible measurements to support diagnosis of ischemic and non-ischemic heart disease.

Sonio, from French company Sonio, is a CE-marked (EU MDR) AI platform for prenatal ultrasound. Its AI provides real-time quality control — automatically identifying required views and anatomical structures and checking image quality — and decision support that links detected ultrasound findings to a thesaurus of fetal anomalies and syndromes, helping clinicians improve completeness and detection during fetal screening.

EyeArt, from US company Eyenuk, was the first system to receive EU MDR Class IIb certification for autonomous AI detection of diabetic retinopathy, age-related macular degeneration and glaucomatous optic nerve damage. It analyses retinal fundus images and returns a screening report within seconds, enabling specialist-level eye screening in primary care without a clinician's review.

IB Lab KOALA (Knee Osteoarthritis Labeling Assistant), from Austrian company ImageBiopsy Lab, is CE-marked under EU MDR (Notified Body TÜV SÜD). It automatically analyses standing knee X-rays to grade osteoarthritis using Kellgren–Lawrence scoring and OARSI joint-space-narrowing measurements, giving radiologists and orthopaedic specialists objective, reproducible parameters for diagnosis and follow-up.

LiverMultiScan, from UK company Perspectum, is a CE-marked (EU MDR, Class IIb) and FDA-cleared multiparametric liver MRI solution. It delivers standardized quantitative metrics — corrected T1 (cT1) for fibro-inflammation, proton density fat fraction for steatosis, and liver iron concentration — providing a non-invasive 'virtual biopsy' to aid diagnosis and monitoring of chronic liver disease.

mdprostate, from German company mediaire, is a CE-marked (EU MDR, Class IIb) prostate MRI solution. It automatically segments the prostate, computes volumetry, and detects and classifies suspicious lesions according to PI-RADS 2.1, providing structured reporting support including longitudinal comparison.

Annalise Enterprise CTB, from Annalise.ai (a Harrison.ai company), is a CE-marked (EU MDR, Class IIb) decision-support solution for non-contrast head CT. It detects up to 130 findings — including a wide range of conditions requiring rapid intervention such as intracranial haemorrhage — and prioritizes the worklist to speed up critical-case review.

Veye Lung Nodules, from Aidence (now part of DeepHealth), is a CE-marked (EU MDR, Class IIb) chest CT AI — one of the first AI devices certified under the MDR. It automatically detects, measures, classifies and tracks the growth of pulmonary nodules, supporting both routine clinical practice and lung cancer screening across European health systems.

Transpara, from Dutch company ScreenPoint Medical, is a CE-marked (EU MDR, Class IIb) and FDA-cleared breast AI used as a concurrent reading aid in mammography screening. It marks regions suspicious for cancer on 2D and 3D mammograms and supports density/risk assessment; randomized trial evidence (MASAI) shows improved detection with reduced reading workload.

Cardiologs (now part of Philips) is a CE-marked (EU MDR, Class IIa) and FDA-cleared deep-learning platform for ECG analysis. It interprets ambulatory/Holter ECG recordings to detect and classify arrhythmias such as atrial fibrillation, reducing manual review time. It was the first FDA-cleared AI solution for ECG analysis (2017).