MedHub-AI, pioneer of AI-based FFR “AutocathFFR” software, today announced a distribution agreement with Terumo Corporation to bring AutocathFFR®, its groundbreaking AI-powered Software as a Medical Device (SaMD), to the Japanese market. This partnership marks a new era in coronary physiology assessment where AI technology delivers superior confidence, reproducibility, and clinical accuracy compared to conventional 3D FFR methodologies.
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.
“Our partnership with Terumo represents a pivotal moment in the evolution of cardiac care,” said Or Bruch-El, CEO of MedHub-AI. “Together, we are ushering in a new era where AI empowers physicians with unmatched speed, accuracy, and reliability. AutocathFFR® overcomes the limitations of traditional and existing 3D-based FFR approaches that often rely on subjective interpretation and operator skill. This is a leap forward toward fully standardized and scalable coronary diagnostics. He added”
“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.”
AutocathFFR® is built on an advanced AI approach that allows MedHub-AI to continually enhance performance, launch improved software versions, and respond to clinical needs with ever-greater precision and usability. The company is currently progressing through the final stages of its regulatory pathway and expects to receive FDA approval within months, marking a pivotal milestone toward broader clinical adoption and global market expansion.
