Acarix wins UAE approval for acoustic heart disease test

Coronary artery disease is one of the heaviest clinical burdens across the GCC, yet the standard diagnostic pathway is slow, resource-intensive, and often involves procedures that could be avoided. Swedish medtech firm Acarix is betting its acoustic technology can change that, starting with the UAE.

Acarix has received regulatory clearance from both the Emirates Drug Establishment and the Ministry of Health and Prevention for its CADScor system. The device will reach the UAE market through local commercial partner UniTech Solutions, which will handle distribution and clinical support.

How does it work?

The CADScor system attaches to a patient's chest and uses highly sensitive acoustics, combined with AI-driven computational analysis, to assess coronary blood flow. It produces a patient-specific CAD-score in under 10 minutes, indicating the likelihood of significant coronary stenosis. The system is designed to rule out significant coronary artery disease with at least 96% negative predictive value, right at the point of care. It has been used in over 60,000 patient assessments and is built on more than 15 years of R&D, backed by 45 patents. It carries CE marking under EU MDR 2017/745 and FDA De Novo clearance.

Why does it matter?

Cardiac imaging and catheterization labs across the Gulf are under real pressure. A fast, non-invasive rule-out tool at the point of care — in the emergency department or outpatient clinic — could reduce unnecessary downstream testing and free up specialist capacity. That's a practical win for overstretched cardiac teams and for patients who currently wait longer than necessary for answers.

• Result in under 10 minutes, no imaging required
• At least 96% negative predictive value
• Designed for chest pain and suspected CAD presentations
• Reduces reliance on invasive and costly follow-up procedures

The context

The UAE is a deliberate first step. Acarix sees the country as a base for broader GCC expansion, where high case volumes and established clinical infrastructure make the case for better triage tools. The approval also fits into a wider regional push, aligned with UAE health transformation goals, to bring faster diagnostics closer to patients and reduce the cost burden on hospital systems. UniTech Solutions CEO Majed Aboalazm described it as addressing a "clear unmet need" for cardiologists and emergency teams alike. So far, the evidence suggests he's right.