Follow the progress of Hemolens Diagnostics
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Follow the progress of Hemolens Diagnostics
July 8, 2026
The official handover of the MDR certificate by the notified body TÜV Rheinland is an important milestone for us – confirming several years of work, many key design decisions, and the commitment of the entire Hemolens Diagnostics team.
In May 2026, we successfully completed the conformity assessment of Cardiolens Viewer® with Regulation (EU) 2017/745 (MDR) and obtained certification of our quality management system in accordance withEN ISO 13485. This was a key moment in preparing the product for market launch.
The next step was the official handover of the certificate by TÜV Rheinland – an event that symbolically marked the culmination of months of preparation and the successful completion of the certification process. The document, which previously existed within internal systems and documentation, was formally presented during a ceremonial meeting.
Cardiolens Viewer® is Hemolens Diagnostics’ first commercial solution, transforming coronary computed tomography angiography (CCTA) into an intuitive, patient-specific 3D visualization of the coronary artery tree. With automatic vessel segmentation, automated detection of potentially clinically significant stenoses, and advanced 3D visualization, the solution supports the assessment of the coronary arteries.
The MDR (EU) 2017/745 Regulation is one of the most demanding regulatory frameworks for medical devices. It covers the assessment of quality management systems, technical documentation, and clinical data in terms of safety and performance.
For SaMD (Software as a Medical Device) based on AI technologies, this process requires particularly rigorous validation. Achieving certification confirms the product’s compliance with applicable regulatory requirements, enabling its use in clinical settings in accordance with its intended purpose.
This achievement would not have been possible without the work and commitment of the entire Hemolens Diagnostics team. Every stage of the process required collaboration across many areas – from technology development, through documentation, to quality management activities.
We would also like to thank TÜV Rheinland for their professional support and partnership approach at every stage of the certification process.
MDR certification for Cardiolens Viewer® represents an important milestone in the development of our technology, but it is not the final step.
We are simultaneously working on the development of further solutions within the Cardiolens ecosystem, supporting non-invasive diagnosis of coronary artery disease at various stages of the patient journey.
More about Cardiolens Viewer® can be found at:
Hemolens Diagnostics – Cardiolens Viewer®
