Medhub.Ai

MedHub is a medical technology company that develops AI-powered non-invasive arterial physiological assessment technologies for cardiac care. The company's flagship product is AutocathFFR, an image-based Fractional Flow Reserve (FFR) system that uses artificial intelligence to analyze coronary angiography images. AutocathFFR is designed to transform routine x-ray coronary angiography into comprehensive physiological information, including automatic stenosis detection and anatomical structure identification. This technology aims to help physicians optimize decision-making, including determining whether a stent is necessary, without the need for invasive procedures.

MedHub's AutocathFFR system can be used in real-time during routine coronary angiography and offline post-procedure. In February 2022, the company completed a pivotal multi-center validation study involving over 300 patients, which demonstrated that AutocathFFR's accuracy exceeds 90% compared to invasive FFR procedures. The study also showed the system's clinical predictive value across various coronary physiologies, including complex lesion assessment in bifurcations and calcified lesions. MedHub has submitted a 510(k) premarket notification to the US Food and Drug Administration for regulatory clearance of AutocathFFR.

The company is expanding its product portfolio to include AutocathMVD for wireless microvascular dysfunction assessment and AutocathiFR for image-based iFR-pullback assessment in vessels with multiple lesions. In July 2023, MedHub announced the development of AutocathTL (Tandem Lesion) system, representing an evolution from the AutocathFFR technology. MedHub's vision is to simplify and streamline cardiac catheterization by replacing costly and invasive supplementary procedures with image-based software solutions.