Imricor Receives Approval from Saudi Food and Drug Authority

17 January 2024 – Minneapolis, United StatesImricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the global leader in real-time iCMR cardiac ablation products, is pleased to announce it has received Medical Device Marketing Authorization (MDMA) from the Saudi Food & Drug Authority (SFDA).

MDMA clears the way for Imricor to begin commercialization efforts in the Kingdom of Saudi Arabia (KSA) through, and in cooperation with, Imricor’s exclusive distributor, Al Faisaliah Medical Systems (FMS). FMS is a prominent distributor in KSA, with an impressive track record of success and more than a billion dollars in annual revenue. FMS brings a wealth of expertise and a robust distribution network to ensure seamless market penetration for Imricor’s technology in KSA.

Nearly 50,000 cardiac ablation procedures are performed annually in KSA, and that number is expected to grow as part of Saudi Vision 2030’s Health Sector Transformation Program (

This milestone underscores Imricor’s progress and commitment to expansion and continued growth in strategic markets.

Imricor’s Chair and CEO, Steve Wedan, said: “We are extremely pleased to receive SFDA approval, and the timing is great, with the Arab Health Medical Expo commencing in less than three weeks. We are very excited to launch our products and grow our business across KSA. This is another significant milestone in pursuit of our vision to deliver real-time iCMR ablations to patients and physicians worldwide.”

FMS, Subsidiary of Tibbiyah Holding Company CEO, Alaa Ameen, said: “With our partnership with Imricor, we’re extremely excited in bringing the unique Imricor iCMR technology to Saudi cardiac Centres that aim to be worldwide leaders in patient outcomes. I’m confident that this state-of-the-art technology will add value to patient outcomes and meet the expectations of the Saudi cardiac Centres. In Tibbiyah Holding Company, we are doing our best to align our customers’ goals with Saudi Vision 2030 to establish the best cardiac Centres in the Middle East region.”


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