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FDA Clears CPETWise Cardiopulmonary Exercise Testing Software
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Fusion42 · 4 September 2026 · Fusion42 review
The FDA granted 510(k) clearance to Medibyt’s CPETWise software, allowing commercialization in the US. The platform reduces cardiopulmonary exercise testing interpretation time by over 50% and standardizes clinical workflows while preserving raw data access for clinicians.
This Wire brief sits within Fusion42's coverage of Health: Diagnostics, and 4 sources have reported it between 1 Sep 2026 and 4 Sep 2026.
◆ ◆ The Wire takeaway
Medibyt’s FDA clearance opens the US market for automated cardiopulmonary exercise testing software, forcing competitors to accelerate or partner to meet these efficiency gains. You gain a chance to approach large clinical users now onboarding advanced automated workflows.
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4 sources · first reported 1 Sep 2026 · latest 4 Sep 2026
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