TEL AVIV, Israel– MedHub-AI has received regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its flagship product, AutocathFFR®, an artificial intelligence-driven software that calculates Fractional Flow Reserve (FFR) from standard coronary angiograms without the need for invasive instruments or medication.
The approval marks a major milestone for both the company and the broader field of AI in cardiology. AutocathFFR® is the first fully automated Software as a Medical Device (SaMD) capable of generating precise FFR values directly from X-ray angiograms in just 37 seconds. Traditionally, FFR assessments require guidewire insertion and vasodilatory drugs to measure pressure differentials inside the coronary arteries. MedHub’s solution bypasses both, offering physicians a faster, safer, and non-invasive alternative in the catheterization lab.
“This is more than a regulatory milestone—it’s a pivotal moment for cardiovascular care,” said Or Bruch El, CEO of MedHub-AI. “AutocathFFR® is transforming clinical workflows with real-time, reproducible insights that remove variability and accelerate decision-making in high-stakes procedures. We’re proud to be the first in our category to bring this fully automated system to market.”
The Japanese approval follows a multicenter pivotal study involving 504 blood vessels at leading hospitals in the United States and Israel. The trial compared AutocathFFR® results against traditional invasive FFR measurements, with analysis conducted by an independent core lab at MedStar Health in Washington, D.C., under the leadership of Dr. Hector Garcia. The study found AutocathFFR® delivered a sensitivity of 90.2%, specificity of 94.9%, and overall diagnostic accuracy of 93.7%.
MedHub-AI’s entry into the Japanese market is further bolstered by a strategic partnership with Terumo Corporation, Japan’s leading cardiovascular device manufacturer. The collaboration is expected to drive the widespread adoption of AutocathFFR® throughout the country’s medical institutions.
“Physicians now have access to a tool that delivers consistent and accurate FFR results in under a minute, without the risks or delays of invasive techniques,” Bruch El added. “We are setting a new standard in cardiac diagnostics and intend to lead the field of AI-powered clinical decision tools.”
The company plans to expand the platform’s global reach, positioning AutocathFFR® as a foundational technology for the future of non-invasive cardiovascular diagnostics.
