Medibyt CPETWise获FDA 510(k)许可 推进心肺运动测试智能化

HERZLIYA, Israel, Sept. 1, 2026 /PRNewswire/ -- Medibyt, a digital health company focused on transforming cardiopulmonary diagnostics through intelligent automation, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to CPETWise (K260242). The clearance marks a major milestone for Medibyt and enables the company to enter the U.S. commercialization phase.

CPETWise is designed to streamline CPET analysis, interpretation, and reporting by transforming complex physiological data into a standardized clinical workflow, while preserving clinician visibility into the underlying data and interpretation.

"Receiving FDA clearance for CPETWise is a transformative milestone for Medibyt," said Or Inbar, CEO and Co-Founder of Medibyt. "It validates the significant work our team has completed and enables us to move forward with commercialization in the United States. Our goal is to make advanced cardiopulmonary diagnostics more accessible, scalable, and practical for everyday clinical use."

The clearance comes as Medibyt builds strong commercial and strategic momentum, including the initiation of a commercial pilot with a leading U.S. CPET company to integrate CPETWise with its systems and streamline data transfer, alongside growing strategic interest from global CPET manufacturers that could support broader commercial collaborations. Medibyt recently completed a 100-case proof-of-concept study at the University of Washington, reporting an average user satisfaction score of 4.5/5 and >50% reduction in CPET interpretation time.

CPETWise demonstration environments are currently deployed at leading institutions, including Columbia University, the University of Washington, UCLA, Sheba Medical Center, Ichilov Medical Center, and additional centers. Alongside commercialization of the FDA-cleared version, Medibyt is continuing to develop its next-generation machine-learning capabilities and has recently achieved encouraging initial classification results. The company has access to approximately 4,000 retrospective CPET records interpreted by leading CPET experts, supporting continued algorithm development and validation.

Looking ahead, Medibyt plans to expand commercialization beyond the United States into additional international markets, while continuing to build partnerships with leading global manufacturers and healthcare organizations. The company also plans to expand beyond CPET into additional cardiopulmonary diagnostic tests, including spirometry and BodyBox pulmonary function testing, and extend its technology into the sports medicine and performance markets.