Acarix receives Regulatory Approval in Saudi Arabia.
Acarix receives Regulatory Approval in Saudi Arabia.
Malmö, Sweden – Acarix AB (publ), a leader in acoustic and AI-based cardiac diagnostics, today announces that its CADScor® System has received regulatory approval in the Kingdom of Saudi Arabia (KSA), marking an important milestone in the Company's expansion into the Middle East.
The approval, confirmed through the Medical Devices Marketing Authorization (MDMA) certificate, represents a significant step toward introducing the CADScor System to the substantial Saudi Arabian healthcare market.
Following receipt of the MDMA certificate, the next step is getting registered with the Saudi Arabian Ministry of Health. Acarix is currently working with its local partners to establish the timeline for this process.
“We are very pleased to have achieved this important regulatory milestone in Saudi Arabia. The approval represents another important step in our strategy to expand access to the CADScor System in international markets. We look forward to progressing the remaining registration activities and preparing for commercial launch,” said Aamir Mahmood, President and CEO of Acarix.
The Company will provide further updates as the registration and commercialization process progresses.