MedHub-AI Gains PMDA Approval in Japan for AutocathFFR®, an AI-Powered Cardiovascular Diagnostic Tool
MedHub-AI, a global frontrunner in artificial intelligence for cardiovascular diagnostics, announced today that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has officially approved AutocathFFR®—the company’s non-invasive, AI-based software designed to assess coronary physiology.
AutocathFFR® stands as the first fully automated Software as a Medical Device (SaMD) capable of computing Fractional Flow Reserve (FFR) values directly from routine X-ray coronary angiograms, without the use of guidewires or vasodilator drugs. Producing results in just 37 seconds, it equips interventional cardiologists with rapid, reproducible, and operator-independent decision support within the cath lab.
FFR is a standard tool used in cardiac catheterization to measure the impact of coronary artery narrowing on blood flow.
Traditionally, determining FFR requires administering vasodilators to widen blood vessels and inserting a pressure-sensing guidewire into the artery. This wire measures internal pressure to compute the FFR, helping clinicians gauge the severity of blockages.
AutocathFFR® significantly modernizes this process by providing accurate FFR readings directly from standard X-ray angiograms through advanced AI algorithms. The software removes the need for invasive tools or drug-induced dilation, delivering consistent, hands-free results in 37 seconds. This advancement offers clinicians accurate and repeatable values, reducing variability and improving procedural efficiency.
AI-FFR Pivotal Study
PMDA approval was based on a multicenter pivotal trial that analyzed 504 coronary vessels from patients treated at six major hospitals in the U.S. and Israel. Each case involved a traditional invasive FFR measurement, which was then compared against AutocathFFR® results evaluated by an independent core lab at MedStar Health in Washington, D.C., led by Dr. Hector Garcia.
The study demonstrated the software’s clinical validity with a sensitivity of 90.2%, specificity of 94.9%, and an overall diagnostic accuracy of 93.7%.
Major Milestone for Japan and AI in Cardiovascular Medicine
This regulatory milestone aligns with MedHub-AI’s strategic alliance with Terumo Corporation, Japan’s foremost provider of cardiovascular devices. The partnership aims to deploy the AutocathFFR® platform throughout Japan and drive adoption of AI-based clinical technologies.
“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 continued, “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 Up: iFR Pullback and VLLM Integration
At the upcoming CVIT conference this July, MedHub-AI will introduce its non-invasive iFR pullback solution, a new addition to its real-time physiology suite, bringing the company closer to a fully wire-free approach to coronary evaluation. This tool will enable visualization of pressure changes along the artery, enhancing the precision of interventional planning.
Simultaneously, MedHub-AI will unveil new features leveraging vision language large models (VLLMs)—a form of AI that interprets angiographic visuals, procedural indicators, and patient-specific information both in real time and retrospectively. With this capability, interventional cardiologists will benefit from intelligent, context-aware insights during and after procedures. The innovative tech aims to showcase the transformative potential of AI in the cath lab environment.
Advancing Toward U.S. and Global Markets
With regulatory clearance now secured in Japan, MedHub-AI is nearing completion of the FDA 510(k) process in the United States. Anticipated approval in the near term will support the company’s global expansion, enabling broader access to its AI-driven diagnostic technology across key international healthcare systems.