Hemolens Diagnostics gets CE mark for Cardiolens Viewer

Hemolens Diagnostics says its AI-powered coronary CT software, Cardiolens Viewer, has earned CE certification under the EU Medical Device Regulation as a Class IIa device. The clearance opens the door to clinical use across the European Economic Area and gives hospitals a regulated tool for analyzing suspected coronary artery disease.

Why it matters: - The CE certification allows Cardiolens Viewer to move from development into regulated clinical use across Europe. - Radiologists and cardiologists in the European Economic Area can now use the software as part of everyday cardiac CT workflows. - The certification gives hospitals, cardiology clinics and imaging centers a non-invasive AI tool for coronary artery disease assessment.

What happened: - Hemolens Diagnostics announced that Cardiolens Viewer received CE certification under the European Medical Device Regulation (EU) 2017/745. - The software was cleared as a Class IIa medical device. - The announcement was made June 26, 2026, from Wrocław, Poland. - Cardiolens Viewer is an AI-based clinical decision support tool for cardiac CT analysis.

The details: - Cardiolens Viewer is designed to visualize, process and analyze cardiac CT data in DICOM format. - The software supports assessment of coronary arteries by helping clinicians evaluate vessel lumen and detect and measure potential lesions. - The intended use is adjunctive care for clinically stable patients with suspected or known coronary artery disease. - Cardiolens Viewer does not replace clinical decision-making. - The software can be integrated into existing diagnostic pathways without changing how CT data is acquired. - Hemolens Diagnostics says the MDR clearance confirms compliance with clinical evaluation, risk management and software lifecycle requirements. - The company says patient data is processed and stored through a secure cloud-based infrastructure in Europe.

Between the lines: - MDR clearance is a meaningful hurdle for AI medical software because it signals the product has passed regulatory review for safety and performance controls. - The product is positioned as a workflow add-on, not a replacement for physician judgment, which may make adoption easier in imaging departments. - Hemolens Diagnostics is using the certification as a foundation for a broader product lineup focused on non-invasive coronary artery disease diagnosis.

What's next: - Cardiolens Viewer may now be marketed in hospitals, cardiology clinics and imaging centers across the European Union. - Hemolens Diagnostics is inviting research institutions and clinical partners to collaborate on implementation, further evaluation and validation studies. - The company is also developing additional solutions for other stages of the patient pathway. - Interested parties can contact Bernard Gołko, CEO of Hemolens Diagnostics, at bernard.golko@hemolens.com for a demo. - The company also directs readers to its LinkedIn page and YouTube channel for more information.

The bottom line: - Hemolens Diagnostics now has a regulated AI cardiac CT product that can be deployed clinically across Europe for coronary artery disease support.