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Withings Reaches Full-Year Profitability in 2025, Powered by U.S. Market and FDA-Cleared Device Revenue

6/30/2026

French healthtech pioneer Withings has confirmed full-year profitability for 2025, with the United States standing as its top market and FDA-cleared medical devices accounting for 66% of the company's revenue.

The announcement, made from Boston on June 30, 2026, places Withings among a narrow group of profitable operators in the connected health space — a sector where sustained profitability remains the exception rather than the rule.

FDA Clearance as a Revenue Engine The 66% revenue share from FDA-cleared medical devices is the structural fact that sets this milestone apart from a typical growth story.

Regulatory clearance in the United States is a high barrier — one that filters out less rigorous competitors and commands premium pricing from health-conscious consumers and clinical buyers alike.