#Japan #Tokyo #Coronary Disease #AutocathFFR #MedHub-AI

MedHub-AI Secures National Reimbursement Approval in Japan for AutocathFFR™ System

MedHub-AI, a leader in innovative healthcare technology, has achieved a significant milestone by receiving national reimbursement approval for its AutocathFFR™ system from the Japanese Ministry of Health, Labour and Welfare (MHLW). This approval, which will take effect on October 1, 2025, comes on the heels of earlier regulatory endorsement by the Pharmaceuticals and Medical Devices Agency (PMDA) within the same year.

The Significance of AutocathFFR™

The AutocathFFR system is the first fully automated, real-time, AI-based fractional flow reserve solution designed to be utilized during coronary angiography. This new technology eliminates the need for traditional pressure wires or hyperemic agents, streamlining the workflow in catheterization laboratories and enabling quick, precise evaluations of coronary artery disease (CAD).

Given that CAD consistently ranks as the leading cause of death globally, including in Japan, the introduction of this AI-driven solution signifies a remarkable step forward in the fight against cardiovascular disease. The technology not only enhances decision-making capabilities for healthcare professionals but also aims to reduce procedural complexity and optimize healthcare costs.

Addressing a Vital Healthcare Challenge

The rising burden of cardiovascular diseases in Japan underscores the urgency for improved diagnostic tools. With AutocathFFR now covered by national reimbursement, hospitals and physicians across the nation will have broader access to this advanced technology, potentially transforming the standard of care. MedHub-AI's strategic partnership with Terumo Corporation will further support the integration of AutocathFFR in numerous hospitals, facilitating rapid adoption.

A Step Ahead of Traditional Technologies

What sets AutocathFFR apart from existing 3D-based FFR solutions is its fully automated approach which does not rely on complex processing or time-consuming analysis. Traditional methods frequently involve detailed 3D reconstructions of coronary anatomy, often leading to variations in results due to manual interventions. In contrast, AutocathFFR employs sophisticated AI algorithms that interact directly with routine angiographic images, providing instant, reproducible physiological assessments during procedures.

This unique methodology minimizes operator dependency and shortens the time required for analysis, thereby improving consistency across different patients and medical facilities. The technology ensures that every case is evaluated, rather than limiting assessments to select individuals.

A Major Achievement for MedHub-AI

Or Bruch-El, the CEO of MedHub-AI, expressed his enthusiasm regarding the approval, stating, “The reimbursement approval in Japan signifies a tremendous accomplishment for MedHub-AI and confirms the clinical as well as economic value of AutocathFFR. This landmark achievement demonstrates our dedication to revolutionizing coronary physiology on a global scale.” He emphasized the need for patients and healthcare professionals to have access to cutting-edge, AI-powered solutions that will reshape clinical practices.

About AutocathFFR™

The AutocathFFR technology offers several critical features that enhance its suitability for widespread adoption:

• - Non-Invasive: The system does not require pressure wires or pharmacological hyperemia.
• - Fast and Efficient: It delivers results within seconds in real-time, ensuring that workflow is not disrupted.
• - Reproducible: Its automated AI processes eliminate variability, guaranteeing consistent outcomes across different clinical settings.
• - Clinically Validated: Multi-center trials indicate that AutocathFFR yields results comparable to those obtained through traditional invasive FFR methodologies.

With these features, AutocathFFR is poised to play a vital role in advancing cardiovascular care throughout Japan and beyond, as MedHub-AI continues to execute its broader global strategy aimed at expanding access to AI-enhanced healthcare solutions.