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September 22, 2020
MedHub’s AutoCathFFR Software System Receives CE Mark Approval
September 22, 2020—MedHub, a medical technology company focused on leveraging artificial intelligence to improve interventional cardiologists’ decision-making, announced that its AutoCathFFR software system has received CE Mark approval.
AutoCathFFR is an automated, image-based cardiac diagnosis system that provides noninvasive fractional flow reserve measurements for cardiac catheterization procedures.
The company advised that the AutoCathFFR is not yet available in Europe, but the certification permits MedHub to market the system to European Economic Area member countries. MedHub's near-term goal is commercialization in the United Kingdom market as part of its strategy to expand into Europe. In June 2020, the company announced that the AutoCathFFR received Israeli AMAR regulatory approval.
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