MedHub-AI's AutocathFFR Gains Reimbursement Approval in Japan

MedHub-AI has received national reimbursement approval from the Japanese Ministry of Health, Labour and Welfare for its AutocathFFR system, effective October 1, 2025. This approval follows regulatory clearance by the Pharmaceuticals and Medical Devices Agency earlier this year, announced in a press release. The AutocathFFR system is the first fully automated, AI-based fractional flow reserve solution that operates in real-time during coronary angiography, eliminating the need for pressure wires or hyperemic agents.

The reimbursement approval is a significant milestone for MedHub-AI, as it expands access to advanced coronary physiology assessment across Japan. The system's integration into the cath lab workflow allows for fast and precise assessment of coronary artery disease, supporting evidence-based decision-making and potentially reducing healthcare costs. This development strengthens MedHub-AI's collaboration with Terumo Corporation to accelerate the adoption of AutocathFFR in hospitals nationwide.

AutocathFFR differentiates itself from other technologies by not relying on 3D modeling, instead using advanced AI algorithms on routine angiographic images to produce instant and reproducible results. This approach reduces operator dependency and enhances consistency, making it suitable for broad adoption in daily clinical practice.