TEL AVIV, Israel, Sept. 22, 2020 /PRNewswire/ -- MedHub, a med-tech company that is leveraging AI to help interventional cardiologists make better decisions, announced today that its AutoCathFFR system has been certified to bear the CE Mark, signifying compliance with the European Union's health and environmental safety regulations. "Following our recent AMAR regulatory approval, the CE Mark is another important milestone for MedHub," said Or Baruch El, MedHub's Chief Executive Officer. Mr. Baruch El added, "This approval paves the way for future expansion into Europe, allowing us to offer a novel, non-invasive tool for cardiac disease assessment in the European Economic Area (EEA)."
CE certification confirms that AutoCathFFR meets European Union quality standards for design, manufacture, and final inspection. While AutoCathFFR is not yet available in Europe, the certification permits MedHub to market the system to EEA member countries. With its near-term goal of penetrating the UK market, the company is pursuing opportunities to expand into Europe as part of its global go-to-market strategy.
MedHub cofounder and Chief Operating Officer, Mr. David Goldman, said, "AutoCathFFR has been designed to make cardiac catheterization procedures more patient-friendly, inexpensive and to simplify the procedures to require as minimal invasive interventions as possible."
MedHub has already entered into agreements with multiple sites regarding purchase of the AutoCathFFR system. These sites are ready and eager to commence procedures now that AutoCathFFR has achieved CE Mark approval.
MedHub has developed the world's most efficient and user-friendly image-based FFR system, built on revolutionary AI technology. MedHub's vision is to simplify and streamline cardiac catheterization by eliminating costly, invasive supplementary procedures and replacing them with image-based software. The company's software platform allows for more accurate and better patient care, thereby accelerating the global transition from conventional to personalized medicine.