AI Medical Device Use-Case Index

Lunit INSIGHT CXR, from South Korean company Lunit, is a CE-marked (EU MDR, Class IIa) chest X-ray AI. It detects and localizes major thoracic findings — lung nodules, consolidation, pneumothorax, fibrosis and more — with abnormality scores, supports tuberculosis screening and flags truly normal studies, helping radiologists prioritize and reduce missed findings. It is the EU-MDR-certified counterpart to the Fujifilm-branded CXR-AID.

QP-Brain, from Spanish company Quibim, is a CE-marked (EU MDR, Class IIa) and FDA-cleared brain MRI tool. It automatically segments and quantifies brain structures and white-matter hyperintensities across ~132 regions, comparing results to a normative database to support objective detection and monitoring of brain atrophy and neurodegenerative disease.

Cardiomatics, a Polish company, provides cloud-based, medical-grade AI for automatic ECG analysis. In 2023 it became the first AI-based long-term ECG interpretation software certified under the EU MDR (Class IIa). It analyses Holter/long-term ECG signals to detect and quantify arrhythmias such as atrial fibrillation and AV blocks, cutting analysis time and producing structured reports for cardiologists.

IB Lab SQUIRREL, from Austrian company ImageBiopsy Lab, is CE-marked under EU MDR (Notified Body TÜV SÜD). It analyses frontal spine radiographs to support scoliosis assessment — automatically detecting and labeling vertebrae, measuring Cobb angles and coronal balance — providing radiologists and orthopaedic specialists with objective, reproducible spinal-morphology measurements and patient-friendly reporting.

QP-Liver, from Spanish company Quibim, is a CE-marked (EU MDR, Class IIa) liver MRI post-processing solution. It automates whole-liver (and abdomen) segmentation and quantifies tissue fat (PDFF) and iron concentration (R2*), giving clinicians a non-invasive assessment of steatosis and iron overload to support diagnosis and monitoring of diffuse liver disease.

The Milvue Suite (SmartUrgences), from French company Milvue, is a CE-marked (EU MDR, Class IIa, NB BSI 2797) X-ray triage and detection tool. It analyses adult and paediatric radiographs in seconds to detect seven families of MSK and chest pathologies, prioritize the worklist and generate pre-reports, helping emergency and radiology teams cut turnaround time and reduce missed findings.

Pi (Prostate Intelligence), from UK company Lucida Medical, is a CE-marked (EU MDR, Class IIb) prostate MRI solution. It automatically segments the prostate and analyses multiparametric MRI to detect and characterize areas suspicious for clinically significant prostate cancer, supporting radiologists in earlier, more consistent detection and risk assessment.

cNeuro, from Finnish company Combinostics, is a CE-marked (EU MDR) brain-imaging platform. Its cMRI application automatically quantifies 133 brain regions and white-matter changes against a normative database, while the cDSI decision-support tool combines imaging and clinical data to aid early detection and differential diagnosis of dementia, Alzheimer's disease, MS, TBI and epilepsy.

Diagnocat is a CE-marked (EU MDR 2017/745) and FDA-cleared dental AI platform. It analyses CBCT scans, panoramic and intraoral radiographs to detect dozens of dental conditions — including caries, periapical lesions and periodontal bone loss — automatically numbers teeth, segments anatomy into 3D models and produces structured radiological reports to support diagnosis and treatment planning.

contextflow, an Austrian spin-off of the Medical University of Vienna, provides CE-marked (EU MDR) computer-aided detection for chest CT. ADVANCE Chest CT detects and quantifies lung nodules, characterizes interstitial lung disease and COPD patterns, tracks nodules over time and offers malignancy scoring, giving radiologists objective support across lung cancer, ILD and COPD.

RetInSight, an Austrian company, offers the first-in-class CE-marked (EU MDR, Class IIa) Fluid Monitor. It analyses routine OCT scans to label each pixel as intraretinal or subretinal fluid and converts these into nanoliter measurements, giving ophthalmologists precise, objective fluid quantification to personalize treatment of neovascular AMD.

Pixyl.Neuro.MS, from French medtech Pixyl, is a CE-marked (EU MDR, Class IIa) and FDA-cleared brain MRI solution. It automatically segments and quantifies multiple sclerosis lesions and brain atrophy in minutes, classifying white-matter hyperintensities and tracking change over time to support neurologists and radiologists in diagnosing and monitoring MS.