An AI-based took to help interventional cardiologists make better decisions developed by MedHub, an Israeli med-tech company, has been certified to bear the CE Mark, signifying compliance with the European Union's health and environmental safety regulations, MedHub announced on Tuesday.
Co-founder and COO David Goldman explained that the company's AutoCathFFR has been designed to make cardiac catheterization procedures more patient-friendly, inexpensive, and to simplify the procedures.
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CE certification confirms that MedHub's 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.
MedHub CEO Or Baruch El called the CE Mark "another important milestone."