19/06/2026
What an exciting day for Hemolens Diagnostics! 🌟
We are pleased to announce that we have officially received our MDR certificate for Cardiolens Viewer®, during a formal handover by Rheinland.
This achievement marks the successful completion of the conformity assessment under Regulation (EU) 2017/745 (MDR) and the certification of our Quality Management System in accordance with EN ISO 13485 📝.
🫀 Cardiolens Viewer®, our first commercial product, transforms coronary CT angiography into an intuitive, patient-specific 3D visualization of the coronary arteries. Using automated vessel segmentation and advanced visualization techniques, it enables automatic detection of potential clinically significant stenoses requiring further assessment and supports evaluation of the coronary arteries.
The certificate confirms that the medical device complies with the applicable requirements of the MDR, including those related to safety, performance, clinical evaluation, and quality management, marking a key step toward its placement on the EU market.
This success would not have been possible without the dedication and commitment of the entire Hemolens Diagnostics team. We extend our sincere thanks and congratulations to everyone who contributed to this achievement, from the early stages of product development through to the successful completion of the certification process 💙.
We would also like to thank TÜV Rheinland for their cooperation, professionalism, and support throughout the entire journey 🤝.
It was an emotional and exciting day - one that fuels our motivation to keep moving forward. We are not slowing down - this is just the beginning 🚀.
Learn more about Cardiolens Viewer® 👉 https://tiny.pl/fzzk69-5t