Withings Body Scan gets FDA nod for sale in the US

Withings has announced that its groundbreaking Body Scan Health Station has received FDA clearance. The device, priced at $399.95, will be available for purchase in the United States this fall. This comes after its launch a few months ago in the UK and EU, where it has already made waves for its innovative features.

FDA clearance: A milestone

The FDA clearance is a significant milestone for Withings. It makes the Body Scan as the world’s first health station to receive such approval for detecting atrial fibrillation via a 6-lead ECG.

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For those not in the know, the FDA is a US federal agency responsible for protecting public health by regulating a wide range of products, including medical devices. Its clearance signifies that the Body Scan has undergone rigorous evaluation and testing to meet the agency’s stringent criteria for safety, effectiveness, and quality.

Beyond weight management

While traditional scales focus on weight, the Body Scan is an all-encompassing health station. It offers daily analysis of biomarkers associated with common health conditions, including heart rate and vascular age.

Segmental body composition

One of the standout features is segmental body composition analysis via Bioelectrical Impedance Analysis (BIA). The electrodes in the base of the device and in the handle provide precise measurements of individual body parts, including the arms, legs, and torso. It’s a leap forward in body composition monitoring, offering a level of detail previously only available in sports labs.

Electrodermal activity monitoring

Developed in collaboration with Impeto Medical, the Body Scan also tracks sweat gland activity in the feet. This feature offers a daily assessment of small nerve activity, which can be crucial for identifying conditions such as degenerative nerve diseases. Users get an easy to understand score.

Cardiovascular health

The Body Scan is also equipped to offer a variety of cardiovascular measurements. It records a 6-lead ECG and tracks heart patterns associated with atrial fibrillation. The device dishes out these types of stats through its patented Vascular Age technology.

Withings Body Scan
Image source: Withings

There’s more

Other metrics that are tracked by the scale include water percentage, visceral fat, muscle mass, bone mass, extra cellular and intracellular water and more. This is coupled with ultra-precise weight measurements (accurate to 50 grams). Withings Body Scan is also able to measure Basal Metabolic Rate, or the number of calories the body burns at rest.

The French outfit has always been about empowering users, and the Body Scan is no exception. The device comes with in-app coaching, clinical specialists, and personalized health plans. These programs are developed by experts in cardiovascular, neurologic, and metabolic conditions, providing users with actionable insights.

As far as hardware, the Body Scan features a high-strength tempered glass platform with an integrated retractable handle. It houses four weight sensors, 14 ITO electrodes, and a high-resolution 3.2-inch LCD color screen. The device runs on a long-life rechargeable battery that offers 12 months of use.

The FDA clearance positions the Withings Body Scan as a significant player in the US smart scale market. Winner of three CES 2022 Innovation Honoree Awards, the device goes way beyond simple weight management, providing users with a comprehensive health assessment right in their homes.

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Marko Maslakovic

Marko founded Gadgets & Wearables in 2014, having worked for more than 15 years in the City of London’s financial district. Since then, he has led the company’s charge to become a leading information source on health and fitness gadgets and wearables.

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