Medibyt’s CPETWise automated platform aims to cut cardiopulmonary exercise testing interpretation time in half and standardize clinical workflows for healthcare providers.
RT’s Three Key Takeaways:
- Regulatory Clearance: The Food and Drug Administration (FDA) granted 510(k) clearance to Medibyt for its CPETWise platform, clearing the way for commercialization across the US.
- Efficiency Gains: A 100-case study at the University of Washington showed that the software reduced cardiopulmonary exercise testing interpretation times by more than 50% with an average user satisfaction score of 4.5 out of 5.
- Workflow Standardization: The system automates test reporting and identifies primary physiological limitations while preserving direct clinician access to raw data and standardized graphical panels.
The USFDA has granted 510(k) clearance for the CPETWise cardiopulmonary exercise test analysis platform, according to to Medibyt. The clearance (K260242) allows the digital health company to launch commercialization efforts in the US, it says.
According to Medibyt, the CPETWise software streamlines cardiopulmonary exercise testing (CPET) analysis, interpretation, and reporting by converting complex physiological data into a standardized clinical workflow, while preserving clinician visibility into raw data and underlying findings.
“Receiving FDA clearance for CPETWise is a transformative milestone for Medibyt,” said Or Inbar, chief executive officer 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.”
Clinical Study Shows Reduced Interpretation Time
In validation testing, Medibyt completed a 100-case proof-of-concept study at the University of Washington, reporting an average user satisfaction score of 4.5 out of 5 and a greater than 50% reduction in CPET interpretation time.
“The current analysis and workflow platform dramatically improves efficiency in cardiopulmonary exercise testing by generating rapid, highly accurate reports,” said Yoni Buber, professor at the University of Washington, in a news release. “It also provides immediate access to raw data and standardized CPET graphical panels, while automatically identifying the primary limiting factor, giving clinicians faster and more actionable insights.”
According to the company, demonstration environments for CPETWise are deployed at institutions including Columbia University, the University of Washington, UCLA, Sheba Medical Center, and Ichilov Medical Center.
Commercial Pilots and Future Expansion
Alongside the regulatory clearance, Medibyt has started a commercial pilot with a leading US CPET company to integrate the platform with existing hardware and streamline diagnostic data transfer, the company stated. Medibyt also reported growing interest from international CPET manufacturers seeking commercial collaborations.
Medibyt noted that it is developing next-generation machine-learning models, supported by access to approximately 4,000 retrospective CPET records interpreted by expert clinicians.
Looking forward, the company plans to expand commercial distribution outside the US and form partnerships with global manufacturers and healthcare organizations. Medibyt also intends to extend its software beyond CPET into additional diagnostic modalities, such as spirometry and BodyBox pulmonary function testing, as well as sports medicine and performance testing.
