Israeli MedTech company MedHub, which leverages AI to help interventional cardiologists make better decisions, announced today that its AutoCathFFR system has been certified by EU standards and has been awarded 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)."
The Israeli company's technology utilizes the power of AI and produces non-invasive diagnostic measures that provides cardiologists with clinical insight, enabling them to make educated, data-backed decisions regarding further patient care. The accurate and real-time data provides medical clinicians a broader picture of the ongoing in a patient's heart, specifically at helping diagnose and quantify arterial stenosis to determine whether significant narrowing is present.
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 was founded in 2018 by CEO Or Baruch El and COO David Goldman. Company headquarters are based in Tel Aviv, and MedHub has secured $1.7 million in Seed funding to-date The company has already entered into agreements with multiple sites regarding the purchase of the AutoCathFFR system, which paired with that new shinny CE approval mark has potential European based customer lining up.