Malmö, Sweden – Acarix, a global leader in AI- and acoustics-based cardiac diagnostics, today announced that its CADScor System has successfully achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745).
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 an important regulatory and strategic milestone for Acarix,” said Aamir Mahmood, President and CEO of Acarix. “EU MDR approval reinforces the strength of our clinical evidence, the robustness of our quality systems, and our commitment to delivering high-value diagnostic solutions to healthcare systems across Europe.”
With MDR certification in place, Acarix is well positioned to support existing customers, expand commercial partnerships, and continue advancing the adoption of the CADScor System throughout the European Union.