Terumo Corporation has recently announced that it has signed a distribution agreement with MedHub-AI to market the "AutocathFFRTM", MedHub-AI’s Software as a Medical Device (SaMD), in Japan. With this agreement, Terumo will start the sales of AutocathFFRTM as a distributor beginning in October 2025.

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.

AutocathFFRTM offers a new approach to coronary physiology assessment by introducing a minimally invasive, AI-powered alternative. Leveraging advanced image analysis, it calculates FFR values directly from X-ray coronary angiography, eliminating the need for insertion of guidewire with a pressure sensor and pharmacological vasodilation. This innovative approach enhances procedural efficiency while improving patient safety and comfort in coronary artery evaluation.

AutocathFFRTM is a SaMD that calculates FFR values by analyzing multiple X-ray images from coronary angiography using AI for patients suspected of having coronary artery disease. Compared to conventional methods that calculate FFR values based on coronary angiography images without AI, AutocathFFRTM enables significantly faster diagnostics, delivering real-time results in just 37 seconds, approximately one-sixth of the time required by traditional approaches. Additionally, its fully automated analysis process eliminates the need for manual intervention, providing highly reproducible evaluation results that are independent of operator variability.

AutocathFFRTM's novel end-to-end AI approach enhances diagnostic efficiency while enabling continuous performance improvements, facilitating the release of improved software versions over time. These iterative advancements further optimize accuracy and usability, ensuring that both clinicians and patients benefit from ongoing innovation.

“MedHub-AI has been seeking the right partner to scale AutocathFFRTM to a wider clinical reach," said Or Bruch-El, CEO of MedHub-AI. "Terumo brings deep commercial expertise and a proven track record of providing only top-tier, groundbreaking technologies that are shaping the future of healthcare. This partnership goes beyond distribution - it is about transforming cardiac care through AI-driven precision, efficiency, and accessibility," he added.

Junichi Osawa, General Manager of MedHub-AI LLC Japan, who played a pivotal role in introducing invasive FFR technology to Japan, views this partnership as a defining moment for AI-driven cardiac care.

"Having led the introduction of invasive FFR into Japan’s market, I can confidently say that what we are seeing now with AutocathFFRTM is an even greater revolution. The adoption and demand for our AI-based FFR technology are growing at an unprecedented rate. The market signals we are receiving are stronger than ever before giving us confidence that we are leading a major shift in cardiovascular diagnostics.”

“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,” said Mitsuhiro Tanba, General Manager, Terumo Interventional Systems Japan, Cardiac and Vascular Company, Terumo Corporation. “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.”

www.terumo.com