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Medibyt Receives FDA 510(k) Clearance for CPETWise, Advancing Cardiopulmonary ...
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Digital Health
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United States
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Fusion42 · 1 September 2026 · Fusion42 review
Medibyt received FDA 510(k) clearance for its CPETWise platform, enabling U.S. commercialisation to advance automated cardiopulmonary exercise test analysis with AI-driven workflow improvements.
This Wire brief sits within Fusion42's coverage of Digital Health, and 3 sources have reported it.
◆ ◆ The Wire takeaway
You can now target U.S. cardiopulmonary diagnostics with a cleared automated test analysis tool. This clearance opens doors to partnerships and regional leads for AI-driven clinical platforms in heart and lung health.
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3 sources · 1 Sep 2026
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Digital Healthfda-clearancecardiopulmonarydigital-healthautomationclinical-diagnostics