AI Reads the Heart: Coronary CT Software Earns CE Certification under EU MDR

▤ Summary

Hemolens Diagnostics has secured CE certification under the EU MDR for its Cardiolens Viewer software. The product uses AI to analyze coronary CT data and support radiologists and cardiologists in assessing coronary artery disease. The certification allows the software to be used clinically across the European Economic Area and signals readiness for regulated deployment. The company says the product can fit into existing diagnostic workflows and has invited clinical partners to collaborate on implementation and validation. This creates a clear opening for hospitals, imaging centers, and research partners that need cardiac imaging software and integration support.

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Hemolens

$1M to $5M