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.

AI-FFR Pivotal Study

The PMDA approval is supported by a multicenter pivotal study that included 504 vessels from patients across six leading hospitals in the United States and Israel. Each patient underwent invasive FFR measurement, which was then compared to AutocathFFR^® results analyzed at an independent core laboratory at MedStar Health in Washington, D.C., led by Dr. Hector Garcia.

The findings demonstrated a sensitivity of 90.2 percent, specificity of 94.9 percent, and overall diagnostic accuracy of 93.7 percent, validating the system's clinical performance and reliability.

Milestone for Japan and for AI in Cardiology

The approval coincides with MedHub-AI's strategic partnership with Terumo Corporation, Japan's leading cardiovascular device company. Together the companies will deliver this breakthrough platform across Japan and accelerate adoption of AI driven clinical tools.

"This PMDA approval is not only a historic achievement for MedHub AI," said Or Bruch El, CEO of MedHub-AI, "but also a turning point for how AI will shape cardiovascular care moving forward. AutocathFFR^® delivers real time, reproducible insights through a fully automated pipeline, enabling physicians to make faster and more confident decisions at the point of care. It is the first end to end AI system in its class to be approved, and we are proud to set this new standard."

He added, "The results from our pivotal study give physicians the confidence they need in high stakes and time critical procedures. Our goal is clear. We intend to lead this category without compromise."

Next in Pipeline: iFR Pullback and Beyond

At the upcoming CVIT conference this July, MedHub-AI will unveil its non invasive iFR pullback solution, expanding its real time physiology suite and moving one step closer to fully wire free coronary assessment. This new capability will allow physicians to visualize pressure gradients along the vessel without the need for invasive tools, enhancing procedural planning and accuracy.

In parallel, the company will debut advanced features powered by vision language large models, also known as VLLMs. These AI systems are designed to interpret angiographic images, procedural cues, and patient specific data in real time and offline. By introducing deep contextual understanding directly into the cath lab, VLLMs will support interventional cardiologists with intelligent and dynamic recommendations both during procedures and in post procedural review. This groundbreaking technology is expected to captivate audiences by revealing the full power and potential of the AI powerhouse MedHub-AI is integrating into the heart of interventional cardiology.

Toward Global Expansion

With PMDA approval now secured in Japan, MedHub-AI is progressing rapidly toward regulatory clearance in the United States. The company is in the final stages of its FDA 510k process and expects approval in the very near future. This next milestone will further accelerate the company's global rollout, bringing its AI powered diagnostic platform to physicians across major healthcare markets worldwide.