MedHub-AI News
10 articles
growth-positive
/PRNewswire/ -- MedHub-AI today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved national reimbursement for the company's...
MedHub-AI has announced that its AutocathFFR™ System has received national reimbursement approval from the Japanese Ministry of Health, Labour and Welfare, effective October 1, 2025. This follows earlier regulatory approval by the Pharmaceuticals and Medical Devices Agency (PMDA). The AutocathFFR is a fully automated, AI-based fractional flow reserve solution that enhances coronary artery disease assessment. The reimbursement approval is expected to expand access to this technology across Japan, strengthening MedHub-AIs collaboration with Terumo Corporation. The systems unique AI-driven approach offers fast, non-invasive, and reproducible results, making it a significant advancement in coronary physiology assessment.
Product StagePartners
growth-positive
/PRNewswire/ -- MedHub-AI, pioneer of AI-based FFR "AutocathFFR" software, today announced a distribution agreement with Terumo Corporation to bring...
MedHub-AI has announced a distribution agreement with Terumo Corporation to introduce its AI-powered software, AutocathFFR®, to the Japanese market. This partnership aims to revolutionize coronary physiology assessment by providing superior accuracy and reproducibility compared to traditional methods. AutocathFFR® uses advanced AI algorithms to calculate FFR values from X-ray coronary angiograms, eliminating the need for invasive procedures. The collaboration with Terumo is expected to expand MedHub-AIs product lineup in the cardiovascular field and enhance patient care. MedHub-AI is in the final stages of its regulatory pathway and anticipates FDA approval soon, which will facilitate broader clinical adoption and global market expansion.
Partners
growth-positive
MedHub-AI Appoints Medical Device Industrial Expert and Cardiac Care Innovator Dr. Justin Davies as President
MedHub Ltd., a medical technology company specializing in AI-powered non-invasive arterial physiological assessment technologies, has appointed Dr. Justin Davies as the companys president. Dr. Davies is a renowned medical device entrepreneur and a pioneer of the instantaneous wave-free ratio (iFR) technique. His appointment is expected to provide further expertise and capabilities to the company as it continues to implement its go-to-market strategy. The company also disclosed the progression in the development of the AutocathTL (Tandem Lesion) system, a natural evolution from the well-established AutocathFFR technology.
Management Changes
growth-positive
MedHub Announces completion of its pivotal multi-center validation study and raises $1 million in new financing
MedHub, a medical device company, has secured $1 million in funding, bringing the total raised to $4.2 million. They have also completed a pivotal validation study for their AutocathFFR™ system and submitted a 510(k) premarket notification to the FDA. The investment will be used to expand commercialization and develop their product portfolio. The AutocathFFR™ system aims to transform routine x-ray coronary angiography into comprehensive physiological information. MedHubs vision is to improve cardiac care by replacing invasive procedures with AI image-based tools.
Investment
growth-positive
MedHub Receives CE Mark Approval for its AutoCathFFR Software
MedHub, a med-tech company, has received CE Mark certification for its AutoCathFFR system, indicating compliance with EU regulations. This certification allows MedHub to market the system in European countries and paves the way for future expansion into Europe. The company aims to penetrate the UK market and is pursuing opportunities for global go-to-market strategy. MedHub has already entered into agreements with multiple sites for the purchase of the AutoCathFFR system. The system is designed to make cardiac catheterization procedures more patient-friendly and less invasive. MedHubs vision is to simplify and streamline cardiac catheterization through its image-based FFR system, which utilizes AI technology.
CustomersPartners
growth-positive
MedHub Appoints Prof. Rafael Beyar, Co-Founder of Cordinus Vascular Robotics, to its Board of Directors
MedHub Ltd, a medical technology company, has appointed Prof. Rafael Beyar as the Chairman of the companys Board of Directors. Prof. Beyar is a renowned medical device and robotics entrepreneur with expertise in helping small and medium-sized companies gain a leading market position. His appointment is expected to aid MedHub in its go-to-market strategy and further expand its capabilities and expertise. MedHub specializes in the development and commercialization of AI-powered technologies for the diagnosis of cardiac disease. The companys vision is to simplify and streamline cardiac catheterization through image-based software. MedHub is currently partnering with multiple sites on its pilot program.
Management Changes
growth-positive
MedHub AutocathFFR Awarded AMAR Certification, Israel's Medical Device Regulatory Approval
MedHub Ltd., a medical technology company, has gained AMAR approval for its AutocathFFR system, an automated cardiac diagnosis system. The approval allows MedHub to offer accessible and affordable FFR measurements to patients in Israel and Europe. AutocathFFR classifies patients based on their hemodynamic stenosis severity, reducing unnecessary therapeutic procedures. MedHub plans to provide AutocathFFR to several Israeli hospitals as early adopters. The system shortens procedure times, saves costs, reduces radiation exposure, and improves quality of care. MedHubs CEO, Or Baruch El, is excited to provide cutting-edge technology to interventional cardiologists.
Customers
growth-positive
MedHub Announces Completion of Its First Validation Clinical Study in Israel
MedHub has developed AutocathFFR, an advanced AI-based solution for interventional cardiologists. AutocathFFR is a fully workflow-integrated system that provides automated image-based stenosis detection and FFR measurement during diagnostic procedures. The validation study showed that AutocathFFR has an accuracy of approximately 90%, equivalent to traditional equipment. MedHub plans to present the detailed statistics at the CRT convention and publish them in a prestigious medical journal. The unnecessary stenting of patients costs the US healthcare system over $4 billion annually, and AutocathFFR aims to reduce unnecessary procedures. MedHub is preparing for a prospective clinical study in the US later this year.
Customers
growth-positive
MedHub's AI-Powered Solutions Are Disrupting Cardiology
MedHub is commencing a pivotal multi-center clinical trial to demonstrate the efficacy of its product AutocathFFR, an AI-based decision-support system for cardiologists. The trial aims to optimize diagnoses, lower costs, and improve treatment outcomes. The current standard diagnostic methods have led to inaccurate diagnoses and unnecessary interventions, costing the American healthcare system $4 billion annually. MedHub believes that AI has the potential to revolutionize medicine and improve decision-making in healthcare. The CEO of MedHub emphasizes the clinical and economic potential of AI in improving healthcare systems. The article does not mention any specific partners, customers, valuation amount, layoffs, investment amount, acquisition amount, or date of the event.
Customers
growth-positive
MedHub's AI-powered cardiology tech enters clinical trial
Tel Aviv-based MedHubs AI decision-support system for cardiologists, AutocathFFR, has entered a clinical trial to demonstrate its efficacy. The system detects stenosis of the coronary arteries and provides relevant physiological parameters to aid in assessing the severity of patients conditions. The trial follows a successful feasibility study, and the results will be published in December 2019. MedHub aims to prevent inaccurate diagnoses and unnecessary procedures, which cost the US healthcare system billions of dollars each year. The company believes that AI has the potential to improve healthcare systems and make quality treatment more accessible.
Customers
