Herzliya, Israel, September 1, 2026
Medibyt, a digital health company focused on cardiopulmonary diagnostics, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to CPETWise, its software platform designed to streamline cardiopulmonary exercise testing (CPET) analysis, interpretation, and reporting. The clearance, identified as K260242, marks an important regulatory milestone for Medibyt and enables the company to begin commercialization of CPETWise in the United States. The platform is designed to transform complex physiological data generated during CPET into a standardized clinical workflow, while maintaining clinician access to the underlying data and interpretation. The company said the clearance will support U.S. commercialization, strategic partnerships, clinical adoption, continued artificial intelligence development, and expansion into international markets.
FDA Clearance Advances Automated CPET Interpretation
CPETWise is intended to help clinicians manage the complex process of analyzing cardiopulmonary exercise-test results. CPET generates multiple physiological measurements during exercise, requiring clinicians to integrate information across respiratory, cardiovascular, and metabolic parameters. Medibyt’s platform is designed to organize this information into a more standardized workflow and assist with analysis, interpretation, and clinical reporting. According to the company, CPETWise preserves clinician visibility into the underlying physiological data while helping users obtain faster and more structured interpretations. The FDA 510(k) clearance provides the regulatory basis for U.S. commercialization, moving CPETWise from development toward broader clinical deployment. Medibyt said it is also initiating commercial collaborations that could help integrate the technology into existing CPET systems and streamline data transfer. The regulatory milestone follows a 100-case proof-of-concept study conducted at the University of Washington. Medibyt reported an average user satisfaction score of 4.5 out of 5 and a greater than 50% reduction in CPET interpretation time during the evaluation. According to the company, clinicians participating in the work highlighted rapid report generation, immediate access to raw data, standardized CPET graphical panels, and automated identification of the primary limiting factor. These capabilities could potentially help reduce the time required for interpretation while giving clinicians a more consistent framework for reviewing complex exercise-testing information.
AI Development Builds on Thousands of CPET Records
Alongside commercialization of the FDA-cleared platform, Medibyt is continuing development of next-generation machine-learning capabilities for cardiopulmonary diagnostics. The company reported encouraging initial classification results and said it has access to approximately 4,000 retrospective CPET records interpreted by leading CPET experts. These records are intended to support continued algorithm development and validation as Medibyt works to expand the analytical capabilities of its technology. The company is also deploying CPETWise demonstration environments at institutions including Columbia University, the University of Washington, UCLA, Sheba Medical Center, and Ichilov Medical Center, providing opportunities for clinical users to evaluate the platform. Medibyt’s development strategy extends beyond CPET. The company plans to expand into additional cardiopulmonary diagnostic tests, including spirometry and BodyBox pulmonary function testing, while also exploring applications in sports medicine and performance. The company said it intends to pursue additional international markets and develop partnerships with global CPET manufacturers and healthcare organizations. By combining regulatory-cleared clinical software with ongoing machine-learning development, Medibyt aims to create a broader connected platform for cardiopulmonary diagnostics.
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Commercial Expansion Targets Global Clinical Adoption
The FDA clearance comes as Medibyt builds commercial momentum through strategic partnerships. The company has initiated a commercial pilot with a leading U.S. CPET company to integrate CPETWise with existing systems and simplify data transfer. Interest from international CPET manufacturers could also support future collaborations and broader deployment. For healthcare providers, the platform’s focus on standardized workflows and faster interpretation could be particularly relevant as demand grows for efficient approaches to complex cardiopulmonary diagnostics. The clearance of CPETWise represents a significant step in the development of digital cardiopulmonary diagnostic technology. While the platform is now cleared for U.S. commercialization, Medibyt’s ongoing machine-learning work and expansion into additional diagnostic applications remain part of its broader development strategy. The company expects the combination of FDA-cleared software, clinical workflow automation, and data-driven analysis to support wider adoption of CPET and potentially improve the efficiency of cardiopulmonary testing in clinical and performance settings.
Source: Medibyt press release
