Acarix Secures Key EU Certification, Eyes Global Cardiac Care Market

OKLAHOMA CITY, OK – February 04, 2026 – Swedish medical device innovator Acarix today confirmed it has achieved the rigorous European Union Medical Device Regulation (EU MDR) certification for its CADScor®System, a non-invasive device for assessing coronary artery disease (CAD). The milestone not only secures the company's footing in European markets but is also being hailed as a critical step in its broader strategy for global expansion, particularly into the United States.

The certification (EU MDR 2017/745) confirms that the CADScor®System complies with the EU's highest standards for safety, quality, and clinical performance. For patients presenting with chest pain, the device offers a rapid, point-of-care method to help clinicians rule out significant CAD, potentially transforming crowded emergency departments and cardiology clinics.

"This certification is more than a regulatory milestone, it's a strategic inflection point for Acarix," said Aamir Mahmood, President and CEO of Acarix, in a statement released today. He emphasized that the certification strengthens the company's ability to scale globally and bring its technology to more clinicians and patients.

Navigating a New Regulatory Gauntlet

Achieving EU MDR certification is no small feat. Implemented to replace the previous Medical Device Directive (MDD), the MDR imposes a significantly more stringent and complex regulatory framework. It demands more extensive clinical data, thorough technical documentation, and robust post-market surveillance throughout a device's entire lifecycle.

The transition has proven to be a formidable challenge for the medical technology industry. Reports have highlighted increased costs, with certification expenses sometimes more than doubling, and significantly longer approval timelines—often stretching to 19-22 months. The heightened requirements have strained resources, particularly for smaller companies, with some firms even withdrawing products from the EU market due to the compliance burden.

By successfully navigating this regulatory gauntlet, Acarix has not only ensured continued market access for the CADScor®System but has also gained a powerful competitive differentiator. The certification serves as a third-party validation of the device's safety and clinical claims, positioning it as a trusted solution in a market where quality and reliability are paramount. This robust European regulatory approval is often seen as a benchmark globally, bolstering a company's credibility as it seeks entry into other major markets.

Reshaping Chest Pain Triage

At the heart of Acarix's strategy is a technology designed to address a fundamental challenge in cardiac care: efficiently and safely evaluating patients with symptoms of stable chest pain. The CADScor®System uses a unique approach, combining highly sensitive acoustics and advanced computational processing. A small sensor placed on the patient's chest listens for sounds of turbulent blood flow in the coronary arteries, which can indicate the presence of stenosis, or narrowing.

Within ten minutes, the system generates a patient-specific risk score. With a negative predictive value of over 96%, the device allows clinicians to confidently rule out significant CAD in low-risk individuals. This rapid, non-invasive assessment at the initial point of care can help avoid a cascade of unnecessary, costly, and often invasive downstream procedures.

The real-world impact of this approach is substantial. The system has already been used on more than 40,000 patients worldwide. An independent, peer-reviewed study published in PharmacoEconomics – Open in June 2025 quantified the potential economic benefits within the U.S. healthcare system. The research concluded that adopting a "CADScor-First" strategy in emergency departments could save hospitals between $7.3 million and $15.3 million for every 10,000 patients evaluated, primarily by reducing avoidable testing and enabling earlier, safer discharge of low-risk patients.

A Transatlantic Strategy: EU Success as a U.S. Springboard

While the EU MDR certification is a European victory, Acarix leadership has made it clear that the achievement is a crucial component of its American ambitions. The company already secured a key foothold in the U.S. market with an FDA DeNovo clearance for the CADScor®System in late 2020. The DeNovo pathway is reserved for novel devices without a clear predecessor on the market, underscoring the system's innovative nature.

The new EU certification complements this FDA clearance, creating a powerful transatlantic regulatory foundation. As Mahmood noted, improving chest pain triage and reducing unnecessary downstream testing are "urgent priorities" in the United States. The company is actively working to translate its clinical value into commercial success stateside.

Acarix has been making steady progress on the critical issue of reimbursement. The company reports that three of the five largest commercial payors in the U.S. have now removed the "experimental" label for CADScor®, a vital step toward broader coverage. It has also secured fixed-rate reimbursement agreements, including one at $300 per test, and is pursuing a nationwide CPT I code to standardize payment. To accelerate adoption, Acarix introduced a flexible, usage-based business model in the U.S. in 2024, which it says has been met with a positive reception from new customers.

The Competitive Frontier in Cardiac Diagnostics

Acarix operates in a dynamic and competitive landscape for non-invasive cardiac diagnostics. Established methods like Cardiac Computed Tomography Angiography (CTCA), Magnetic Resonance Imaging (MRI), and stress tests are mainstays in cardiology. However, these tools are often resource-intensive, expensive, and not always suitable for a first-line assessment in a busy emergency or primary care setting.

The CADScor®System is positioned not as a replacement for these technologies, but as a crucial gatekeeper. Its primary function is to rapidly and accurately identify the large majority of patients with non-cardiac chest pain, allowing clinicians to focus resources, time, and more advanced diagnostics on the smaller subset of patients who are truly at high risk. By providing a clear rule-out, the system helps alleviate patient anxiety, reduce hospital wait times, and lower the overall economic burden of chest pain evaluation.

With its dual EU and U.S. regulatory approvals, a growing body of evidence supporting its economic benefits, and a clear strategy for market penetration, Acarix is poised to advance its mission. The EU MDR certification is the latest, and perhaps most significant, validation that this innovative acoustic technology is ready to play a larger role on the global stage of cardiovascular medicine.