Swedish medical device company Acarix has secured regulatory approval for its CADScor system in the United Arab Emirates (UAE), a step that paves the way for commercial availability of the device.
Clearance has been granted by both the Emirates Drug Establishment (EDE) and the Ministry of Health and Prevention (MOHAP).
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The company will launch the CADScor system in the UAE through its commercial partner UniTech Solutions, which is set to manage distribution, clinical support, and account development in the region.
The system is a point-of-care diagnostic aid designed for rapid assessment of coronary blood flow.
Using acoustics, computational analysis and AI, the device provides clinicians with a patient-specific result in under ten minutes to help rule out significant coronary artery disease in individuals presenting with chest pain or shortness of breath.
Acarix states that the system supports early risk stratification and may reduce the need for more invasive and expensive diagnostic tests.
Acarix CEO Aamir Mahmood said: “Coronary artery disease is a leading health burden across the Gulf, and the diagnostic pathway remains longer and more resource-intensive than it needs to be.
“Bringing the CADScor system to the UAE gives frontline clinicians a fast, non-invasive way to rule out CAD at the point of care. This matters for the patients and clinicians we serve.”
The company noted that approval in the UAE also provides a base for access to a wider potential market within other Gulf Cooperation Council countries.
CADScor has been used in more than 60,000 patient evaluations and is designed to rule out significant coronary artery disease with at least 96% negative predictive value at the point of care.
The system holds a CE mark in accordance with EU medical device regulation (MDR) 2017/745 and received de novo clearance from the US Food Drug and Administration. It is based on more than 15 years of research and development with 45 associated patents.
