Deployment

Withings, a French consumer-health-electronics company founded in 2008 and independent again since 2018 after being bought back from Nokia, makes the ScanWatch line of biometric-primary hybrid analog smartwatches with cardiac and respiratory AI augmentation, recorded in the new biometric form factor. The ScanWatch 2 and ScanWatch Nova pair an analog dial with optical heart-rate, electrical ECG, blood-oxygen, and continuous temperature sensors on roughly a 30-day battery. Their FDA clearances are the ECG app, cleared in October 2021 to classify atrial fibrillation, sinus rhythm, and high heart rate for adults 22 and older, updated in July 2025 so that the ScanWatch 2 ECG is cleared over the counter, no longer requiring a board-certified cardiologist to activate, with a new eight-classification atrial-fibrillation algorithm, plus a cleared blood-oxygen feature that supports tracking breathing disturbances at night. A cap-flag applies because the breathing-disturbance detection is a screening aid rather than a sleep-apnea diagnosis, and framing it as diagnosis exceeds scope. Withings offers a clean contrast to Apple, since its blood-oxygen and ECG features were never disabled in the US as it is not party to the Masimo dispute, and the notable 2025 regulatory event was a positive over-the-counter liberalization rather than a restriction. It sells by hardware purchase with an optional Withings+ membership, its clinical-validation posture is substantial for its size with strong study framing and CE medical marking, and the exact clearance numbers and dates for the ScanWatch 2 blood-oxygen and temperature features and the standard US list prices are approximate and not fully verified.

Withings ScanWatch by Withings · Catalog entry · 1 source · not yet field-verified