Follow the progress of Hemolens Diagnostics
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Follow the progress of Hemolens Diagnostics
May 22, 2026
We have successfully completed the MDR (EU) 2017/745 conformity assessment procedure for Cardiolens Viewer®. The assessment was conducted by TÜV Rheinland LGA Products GmbH, a notified body registered with the European Commission under number 0197. CE marking paves the way for the commercialization of our system in the European market.
MDR (EU) 2017/745 conformity assessment is among the most stringent regulatory procedures in the world. It encompasses a quality management system audit and a review of the medical device’s technical and clinical documentation to confirm its safety and performance. For an AI-powered SaMD product, the bar is particularly high.
Cardiolens Viewer® is intended to support the analysis of coronary computed tomography angiography (CCTA) studies. The system generates three-dimensional visualizations of the coronary vasculature, which may assist in assessing coronary arteries, including identifying significant stenoses. It is designed for use by radiologists and cardiologists as a decision-support adjunct within the diagnostic workflow and does not substitute for the clinician’s judgment.
CE marking enables the commercialization of Cardiolens Viewer in the European Union market, subject to compliance with applicable local requirements. For investors and clinical partners, this represents a substantive de-risking milestone: independent technical, clinical, and regulatory scrutiny has been completed by a recognized third party.
“MDR evaluates a product across every dimension – technical, clinical, and regulatory. Successfully completing this procedure confirms that Cardiolens Viewer® meets the safety and performance requirements defined under MDR. For our partners and investors, it is a clear signal that they are working with a company ready for a demanding market.” — Bernard Gołko, Chief Executive Officer, Hemolens Diagnostics
“Early pilot data from RUO points consistently in the same direction: shorter interpretation times, improved diagnostic accuracy, and fewer unnecessary invasive referrals. In the context of value-based care and the growing pressure to reduce procedural burden, that is precisely what health systems are looking for.” — Paweł Paluch, Commercial Director, Hemolens Diagnostics
Cardiolens Viewer® is the first in a planned family of Hemolens Diagnostics products designed to support non-invasive diagnosis of coronary artery disease. In parallel, the company is developing additional solutions intended to assist clinicians at different stages of the patient pathway.
