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www.fdanews.com/articles/212470-fda-clears-withings-400-health-station-to-measure-ecg-body-composition

FDA Clears Withings’ $400 Health Station to Measure ECG, Body Composition

August 30, 2023

Withings’ Body Scan health station received FDA clearance for its weight-scale style device that provides users a home electrocardiogram (ECG).

To be priced at $399.95, the company said, the device provides users detection of atrial fibrillation through a six-lead ECG recorded from two sets of electrodes in the handle and in the base of the scale, with results delivered to a phone app.

The device also measures body composition — whole-body fat and water percentage, visceral fat, muscle and bone mass as well as individual body parts, including torso, arms, and legs. Also provided is basal metabolic rate, which is the number of calories a body burns at rest.

The Body Scan turns “the morning weigh-in into a sophisticated home health check” the company said.

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