Acarix Secures EU MDR Certification for CADScor® System to Assess Coronary Artery Disease

Acarix has obtained EU MDR certification for its CADScor® System, marking a significant milestone in regulatory compliance. The certification ensures that the CADScor® System meets the requirements of the European Union Medical Device Regulation (EU MDR), which governs the safety and performance of medical devices within the EU market.

The CADScor® System is designed to assist healthcare professionals in assessing patients with symptoms suggestive of coronary artery disease. The EU MDR certification confirms that the device complies with stringent standards related to clinical evaluation, risk management, and post-market surveillance. This approval allows Acarix to continue marketing and distributing its product across Europe under these updated regulations.

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Date: February 4, 2026

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GOAI