Finally, more than 18 months after we first saw it and a year after we reviewed the version launched in Europe, the Withings ScanWatch smartwatch has been given approval by the Food and Drug Administration (FDA) and will launch in the U.S. in November. The smartwatch is the first wearable to gain FDA approval for both blood oxygen (Sp02) measurements and detecting atrial fibrillation (AFib) using an electrocardiogram on a wrist.

withings, scanwatch, fda approval

Andy Boxall/Digital Trends

Withings CEO Mathieu Letombe explained what this means:

“ScanWatch has been clinically validated to detect AFib and can aid in the detection of breathing disturbances at night, that can be signs of sleep apnea. It is our most ambitious medical watch to date and has the potential to benefit millions of people.”

Using the PPG sensor on the back to monitor for heartbeat irregularities, the ScanWatch will recommend a 30-second ECG scan if any are detected. Readings can be shared with a medical professional for further assessment. The Sp02 sensor is useful for sleep monitoring, as data collected on heart and respiratory rate can help identify breathing disturbances that may be related to sleep apnea.

This comprehensive health tracking is joined by other features including fitness tracking with 30 different activities including swimming and cycling covered, built-in GPS, and a small PMOLED screen that shows activity data and notifications from your phone. The accompanying Health Mate app works with both Android and iOS.

The ScanWatch itself is made from stainless steel and has a domed sapphire crystal over the dial and screen, and is water-resistant to 5ATM. It comes in either 42mm or 38mm case sizes, with a black or white dial, and with a fluoroelastomer strap. Despite it having a small screen the battery should still last for up to 30 days before it needs recharging, depending on your use. If you constantly engage the GPS, for example, this will drop though.

Withings says the ScanWatch will be released in the U.S. during November when the 42mm version will cost $299 and the 38mm will be $279. A version in rose gold will arrive early next year also for $299, and will be joined by the recently announced $499 Horizon version too. It’ll be sold through Withings own online store, Amazon, and Best Buy. We gave the ScanWatch a Recommended Product award when we reviewed it in September 2020, and will shortly be revisiting the ScanWatch to see if anything has changed.

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