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.
GSK commits USD30bn to US R&D and manufacturing expansion
ArtPlayer Promotes Elderly Wellbeing with Digital Signage and Streaming Art in Finnish Care Homes
Implantica produces 10,000 RefluxStop units ahead of planned US launch
Saol Therapeutics receives US FDA Complete Response Letter for SL1009 (DCA) in PDCD
Abbott's Navitor TAVI system granted CE Mark for expanded indication
PharmaResearch names VIVACY as European distribution partner for Rejuran
Airiver medical receives FDA approval for central airway stenosis trial
Talphera reaches enrollment milestone in NEPHRO CRRT pivotal trial
QT Imaging signs exclusive USD33m distribution deal with Gulf Medical in Saudi Arabia
Novocure submits FDA PMA for Tumor Treating Fields therapy in pancreatic cancer
Covalon Technologies secures DTC eligibility to expand US investor access
Navamedic ASA secures final approvals for Flexilev in OraFID across Nordic markets
Oncopeptides partners with SD Pharma to expand Pepaxti access in Spain