The MDR certification confirms that the CADScor®System meets the European Union’s most stringent regulatory requirements for safety, quality, and clinical performance. This milestone ensures continued and expanded access to the CADScor®System across European markets and supports Acarix’s long-term growth strategy in the region.

The CADScor®System is a non-invasive, point-of-care diagnostic aid designed to help rule out significant coronary artery disease in patients presenting with chest pain, enabling faster clinical decision-making while reducing unnecessary downstream testing.

“This certification is more than a regulatory milestone, it’s a strategic inflection point for Acarix,” said Aamir Mahmood, President and CEO of Acarix. “EU MDR strengthens the foundation we need to scale the CADScor®System globally, and it supports our push to bring a faster, non-invasive approach to ruling out significant coronary artery disease to more clinicians and patients, including in the United States, where improving chest pain triage and reducing unnecessary downstream testing remain urgent priorities.”