MedHub-AI has achieved a significant regulatory milestone with the approval of its AutocathFFR® system by Japan's Pharmaceuticals and Medical Devices Agency (PMDA), marking the first fully automated AI-powered Software as a Medical Device (SaMD) for coronary artery assessment to receive regulatory clearance in the country.
Revolutionary Approach to Coronary Assessment
AutocathFFR® represents a paradigm shift in how physicians evaluate coronary artery disease by calculating Fractional Flow Reserve (FFR) values directly from standard X-ray coronary angiograms using advanced AI algorithms. The system eliminates the need for invasive guidewires with pressure sensors or drug-induced vessel dilation, delivering results in just 37 seconds with operator-independent precision.
Traditional FFR procedures require administering vasodilatory drugs to dilate blood vessels, followed by insertion of a guidewire equipped with a pressure sensor into the coronary artery. The sensor measures intravascular pressure changes to determine FFR values, enabling physicians to assess the severity of arterial blockages. AutocathFFR® revolutionizes this standard of care by providing fast, hands-free consistent FFR results that minimize operator variability and enhance overall workflow reliability.
Clinical Validation and Performance Data
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 study findings demonstrated impressive clinical performance metrics: 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 against the gold standard of invasive FFR measurement.
Strategic Partnership and Market Entry
The approval coincides with MedHub-AI's strategic partnership with Terumo Corporation, Japan's leading cardiovascular device company. This collaboration will deliver the breakthrough platform across Japan and accelerate adoption of AI-driven clinical tools in the cardiovascular space.
"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."
Mitsuhiro Tanba, General Manager, Terumo Interventional Systems Japan, Cardiac and Vascular Company, emphasized the partnership's significance: "Terumo offers a variety of medical devices designed for high operability and enhanced therapeutic outcomes for patients, covering the comprehensive process of catheter diagnosis and treatment. With this partnership with MedHub-AI, we will expand our product lineup in the cardiovascular field, offering a wider range of options to healthcare professionals and contributing to the improvement of the quality of life for patients."
Pipeline Expansion and Future Technologies
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.
The company will also debut advanced features powered by vision language large models (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.
Global Regulatory Progress
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.
AutocathFFR® is built on a proprietary AI framework that allows the platform to continuously improve performance, adapt to new clinical needs, and deliver updated software with greater precision and speed. The system's advanced AI approach enables MedHub-AI to continually enhance performance, launch improved software versions, and respond to clinical needs with ever-greater precision and usability.
