The platform addresses a long-standing bottleneck in cardiac care by transforming physiological data into actionable reports. During a 100-case proof-of-concept study at the University of Washington, clinicians reported a 50% reduction in interpretation time while maintaining high diagnostic accuracy. Prof. Yoni Buber noted that the system provides immediate access to raw data and graphical panels, allowing practitioners to identify primary limiting factors faster than traditional methods.
Medibyt Secures FDA Clearance for CPETWise Diagnostic Software
With FDA 510(k) clearance in hand, Israel-based digital health firm Medibyt is launching its CPETWise platform into the U.S. market. The software aims to automate the complex analysis of cardiopulmonary exercise tests, shifting the burden of data interpretation from manual review to a standardized, high-speed clinical workflow.
Medibyt is currently moving beyond initial validation to secure its commercial footprint. The company has initiated a pilot program with a major U.S. CPET provider to integrate its software into existing clinical systems. Demonstration environments are already active at research hubs including Columbia University, UCLA, and Sheba Medical Center. Following this U.S. entry, CEO Or Inbar plans to scale the technology into international markets and expand the platform’s capabilities to include spirometry and sports medicine performance metrics.
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