MedHub-AI, a global leader in AI-powered cardiovascular diagnostics, announced today that the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has approved AutocathFFR®, the company’s non-invasive, AI-driven software solution for evaluating coronary physiology.
AutocathFFR® is the first fully automated Software as a Medical Device (SaMD) that calculates Fractional Flow Reserve (FFR) values directly from standard X-ray coronary angiograms without the need for guidewires or vasodilatory agents. Generating results in just 37 seconds, the system provides interventional cardiologists with fast, reproducible, and operator-independent decision support in the cath lab.
Fractional Flow Reserve (FFR) is a commonly used technique in cardiac catheterization for assessing the extent of blood flow reduction in narrowed coronary arteries.
Traditionally, this procedure involves administering a vasodilatory drug to dilate the blood vessels, followed by the insertion of a guidewire equipped with a pressure sensor into the coronary artery. The sensor measures intravascular pressure changes to determine the FFR value, enabling physicians to assess the severity of arterial blockages.
AutocathFFR® revolutionizes this standard of care by calculating precise FFR values, fully automatically, directly from routine X-ray coronary angiograms using advanced AI algorithms, eliminating the need for invasive guidewires with a pressure sensor or drug-induced vessel dilation. AutocathFFR® delivers fast, hands-free consistent FFR results in just 37 seconds, empowering cardiologists with precise, reproducible values that minimize operator variability and enhance overall workflow reliability.
