Singapore, June 20 -- Israel-based startupMedHub-AI, a global leader in artificial intelligence (AI)-powered cardiovascular diagnostics, has announced that the Pharmaceuticals and Medical Devices Agency (PMDA) inJapanhas approved AutocathFFR, the company's non-invasive, AI-driven software solution for evaluating coronary physiology.
AutocathFFRis 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.
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