Acarix Receives EU MDR Certification for the CADScor®System

Rhea-AI Summary

Acarix (symbol ACIXF) announced that its CADScor®System achieved EU MDR (2017/745) certification on February 4, 2026, confirming compliance with the EU's highest safety, quality and clinical performance requirements.

This regulatory milestone enables continued and expanded access across European markets, supports accelerated commercial adoption and clinical use, and reinforces the company's pathway to broaden adoption, including planned efforts toward U.S. market expansion.

Positive

• EU MDR certification for CADScorSystem achieved on Feb 4, 2026
• Certification confirms compliance with EU MDR 2017/745 regulatory standard
• Enables continued and expanded access across European markets
• Supports acceleration of commercial adoption and clinical use
• Reinforces pathway toward broader U.S. market expansion

Negative

• None.

News Market Reaction – ACIXF

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+15.19% News Effect

On the day this news was published, ACIXF gained 15.19%, reflecting a significant positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

OKLAHOMA CITY, Feb. 4, 2026 /PRNewswire/ -- Acarix today announced 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 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."

With EU MDR certification secured, Acarix is positioned to accelerate commercial momentum and deepen clinical adoption while advancing its broader global growth strategy. The milestone reinforces the company's ability to execute at the highest regulatory standard and supports Acarix's long-term pathway toward expansion in the U.S. market, where health systems continue to prioritize more efficient, evidence-backed diagnostic solutions that can improve patient flow, reduce avoidable testing, and help clinicians make faster, more confident decisions at the point of care.

For more information, contact:
Macie May
+1 405 517 5161
mmay@saxum.com 

About Acarix
Acarix is a Swedish medical device company that innovates solutions for rapid rule out of coronary artery disease (CAD) at point of care. The CE-approved and FDA DeNovo-cleared Acarix CADScor®System is intended for patients experiencing chest pain with suspected CAD and designed to help reduce millions of unnecessary, invasive, and costly diagnostic procedures. The CADScor®System has been used on more than 40,000 patients. Acarix recommends CADScor®System as a first-line diagnostic aid that uses highly sensitive acoustics and advanced computational processing to analyze coronary blood flow to rule out significant coronary artery disease (CAD), with at least 96% certainty at point of care. Acarix is listed on the Nasdaq First North Premier Growth Market in Stockholm (ticker: ACARIX) and cross-traded on the OTCQB market in the U.S. (ticker: ACIXF). Carnegie Investment Bank is the Certified Advisor of Acarix. For more information, please visit www.acarix.com.

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SOURCE Acarix

FAQ

What did Acarix (ACIXF) announce on February 4, 2026 about the CADScorSystem?

Acarix announced that the CADScorSystem received EU MDR (2017/745) certification on February 4, 2026. According to Acarix, this confirms the device meets EU safety, quality and clinical performance standards and enables expanded access across Europe.

How does EU MDR certification affect CADScorSystem availability in Europe for ACIXF?

EU MDR certification allows continued and expanded CADScorSystem access across European markets. According to Acarix, the certification removes regulatory barriers and supports deeper clinical adoption and commercial rollout in Europe.

What clinical role does the CADScorSystem play for patients with chest pain according to Acarix?

The CADScorSystem is a non-invasive, point-of-care diagnostic aid to help rule out significant coronary artery disease. According to Acarix, it supports faster decision-making and may reduce unnecessary downstream testing in chest pain evaluation.

Will the EU MDR clearance speed Acarix's commercial growth and U.S. plans for ACIXF?

The certification is expected to accelerate commercial momentum and clinical adoption in Europe and support U.S. expansion efforts. According to Acarix, EU MDR strengthens regulatory foundation for scaling the CADScorSystem globally.

Who can investors contact for more information on Acarix (ACIXF) and the CADScorSystem update?

Investors can contact Acarix's media representative provided in the announcement for details. According to Acarix, Macie May is listed as the contact with phone and email for additional information.