MedHub-AI’s AutocathFFR Approved in Japan

June 18, 2025—MedHub-AI announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved AutocathFFR, the company’s noninvasive, artificial intelligence (AI)-driven software solution for evaluating coronary physiology. On June 17, MedHub-AI announced a distribution agreement with Terumo Corporation to bring AutocathFFR to the Japanese market.

Additionally, the company advised it is in the final stages of the FDA 510(k) process and expects regulatory approval in the United States in the near future.

According to the company, AutocathFFR is a 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. The system generates results in 37 seconds, providing interventional cardiologists with fast, reproducible, and operator-independent decision support in the catheterization lab.

As noted in the press release, the PMDA approval was supported by the multicenter AI-FFR pivotal study that included 504 vessels from patients across six leading hospitals in the United States and Israel. Each patient in the study underwent invasive FFR measurement, which was then compared to AutocathFFR results analyzed at an independent core laboratory at MedStar Health in Washington, DC, led by Hector Garcia, MD.

The study findings demonstrated a sensitivity of 90.2%, specificity of 94.9%, and overall diagnostic accuracy of 93.7%, validating the system’s clinical performance and reliability, reported MedHub-AI.