Acarix Receives Regulatory Approval for the CADScor® System in the UAE (United Arab Emirates)
Acarix AB (publ) has announced that its CADScor ® System has received regulatory approval from the Emirates Drug Establishment (EDE) and the Ministry of Health and Prevention (MOHAP), allowing for commercial availability in the United Arab Emirates. This approval represents Acarix's entry into the Gulf region and expands the reach of the CADScor System, which is a point-of-care diagnostic tool designed to assess coronary blood flow and rule out significant coronary artery disease (CAD) in patients experiencing chest pain or shortness of breath.
The CADScor System provides patient-specific results in under 10 minutes, facilitating earlier risk stratification and decreasing the reliance on more invasive and costly subsequent testing. Aamir Mahmood, President & CEO of Acarix, noted the significance of this development, stating that coronary artery disease poses a considerable health burden across the Gulf, and the diagnostic process often requires more resources and time than necessary.
Acarix views the UAE as a strategic platform for expanding its market presence in the wider Gulf Cooperation Council (GCC) region, where high patient volumes and established clinical infrastructure enhance the demand for effective diagnostic tools. Beji George, Head of Global Strategy at Acarix, emphasized that the market's infrastructure and appetite for innovative technology create a strong foundation for the company's growth in the region.
The CADScor System will be brought to market in the UAE through commercial partner UniTech Solutions, which will handle distribution, clinical support, and account development. Majed Aboalazm, CEO of UniTech Solutions, expressed pride in introducing the system to healthcare providers in the UAE, underscoring the tool's capacity to meet a critical need in the early assessment of coronary artery disease.
The CADScor System has been utilized in over 60,000 patient assessments and is built on more than 15 years of research and development, protected by 45 patents. The system is CE-marked in compliance with EU regulations and has received FDA De Novo clearance. Acarix is a Swedish medical device company listed on the Nasdaq First North Premier Growth Market in Stockholm.