Israeli medical technology company MedHub-AI announced on Friday that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved national reimbursement for the company's AutocathFFR System, effective 1 October 2025.
This decision follows regulatory approval by the Pharmaceuticals and Medical Devices Agency (PMDA) earlier this year and provides access to advanced coronary physiology assessment in Japan.
According to MedHub-AI, the approval provides physicians and hospitals across Japan with broad access to AutocathFFR, its 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 hyperaemic agents, AutocathFFR is designed to integrate into the cath lab workflow, enabling fast and precise assessment of coronary artery disease.
AutocathFFR has received regulatory approvals in Japan and is part of MedHub-AI's broader global strategy to expand access to AI-driven solutions for cardiovascular care.
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