MedHub-AI announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved national reimbursement for the company's AutocathFFR™ System, effective October 1, 2025. The decision follows regulatory approval by the Pharmaceuticals and Medical Devices Agency (PMDA) earlier this year and marks a significant milestone in expanding access to advanced coronary physiology assessment in Japan.

The approval provides physicians and hospitals across Japan with broad access to AutocathFFR, the first fully automated, real-time AI-based fractional flow reserve (FFR) solution performed intra-procedurally during coronary angiography. By removing the need for pressure wires or hyperemic agents, AutocathFFR integrates seamlessly into the cath lab workflow, enabling fast and precise assessment of coronary artery disease (CAD).

Addressing a Critical Healthcare Need

Coronary artery disease is the number one cause of morbidity and mortality worldwide, including in Japan where the burden of cardiovascular disease continues to rise. The introduction of AI-driven, non-invasive physiology represents an important advancement for both clinicians and patients by supporting evidence-based decision-making, reducing procedural complexity, and potentially lowering overall healthcare costs.

With reimbursement now established, AutocathFFR is positioned to play a central role in improving access to advanced CAD assessment throughout Japan. This milestone further strengthens MedHub-AI's strategic collaboration with Terumo Corporation to accelerate adoption and integration of AutocathFFR across hundreds of hospitals nationwide.

Differentiation from 3D-Based FFR Solutions

Unlike 3D image reconstruction-based physiology technologies that require complex processing, manual steps, and time-consuming analysis, AutocathFFR is fully automated and does not rely on 3D modeling of coronary anatomy. Instead, it applies advanced AI algorithms directly to routine angiographic images, producing physiology results instantly and reproducibly within the procedure.

This unique approach reduces operator dependency, shortens analysis time, and enhances consistency across patients and centers. These advantages make AutocathFFR ideally suited for broad adoption in daily practice, ensuring that physiology assessment is available for every case, not just selected patients.

Advancing Global Strategy

"Reimbursement approval in Japan represents a major achievement for MedHub-AI and validates the clinical and economic value of AutocathFFR," said Or Bruch-El, Chief Executive Officer of MedHub-AI. "This milestone underscores our commitment to advancing coronary physiology worldwide and to ensuring that patients and physicians have access to innovative, AI-driven solutions that transform clinical practice."