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Medibyt secures FDA clearance for CPETWise digital health platform
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Fusion42 · 5 September 2026 · Fusion42 review
Medibyt has secured FDA 510(k) clearance for its CPETWise digital health platform, enabling US commercialisation to assist clinicians with cardiopulmonary exercise test analysis. The company is expanding commercial use and developing machine-learning features with growing interest from international partners.
This Wire brief sits within Fusion42's coverage of Digital Health, and 5 sources have reported it between 1 Sep 2026 and 4 Sep 2026.
◆ ◆ The Wire takeaway
FDA clearance opens US market access to you if you build clinical software for cardiopulmonary diagnostics. The way is clear to integrate and pilot your solution with providers facing pressure to reduce interpretation time.
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5 sources · first reported 1 Sep 2026 · latest 4 Sep 2026
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