Withings' new smart scales await approval from US and EU regulators

The French electronics maker's innovative new smart scales are set to hit the US and European market but only after they clear regulators.

In the world of consumer electronics it's rare that a product has to be approved by government health regulators. But that’s the case with the French electronics innovator Withings, whose remarkable new Body Scan device has been unveiled at the Consumer Electronics Show (CES) 2022 in Las Vegas this week.

The Body Scan is a set of bathroom scales which does far more than mere weight measurement. The gadget is capable of measuring how fat is distributed throughout the body and assessing the impact of this on overall health. It does this through a series of sensors embedded in the platform and through a hand-held bar that is tethered to the scale by a retractable wire.

Both the sensors in the pad and the hand-held bar send a low-grade electrical signal throughout the body. The signal measures body composition via bioelectrical impedance analysis (BIA). The device can differentiate your body fat, water, and lean mass composition depending on the level of resistance the electrical current receives as it travels through the body.

The Withings Body Scan device is not the first smart scales to use BIA to measure body composition but the inclusion of the retractable bar means that the measurement can be measured from multiple points of contact allowing for a much clearer picture of body health.

While the Body Scan was launched this week at CES its electrical components must first meet the approval of the US Food and Drug Administration (FDA) in the US and the Conformité Européenne (CE) regulatory standard in Europe before it can be released. 

In a press release to coincide with the product's launch Withings said that "the ECG and Nerve Activity Assessment features for this device are subject to change following CE/FDA clearance."

The Body Scan contains four weight sensors and 14 ITO electrodes in the scale itself, plus an additional four located in the handle to measure heart-rate.

Other biometric data it can measure include 6-lead ECG recordings to detect arrhythmia, and vascular age (arterial health) measurement. The company also clams the device's algorithms can detect heart rhythm patterns associated with atrial fibrillation.

This is not the first time a Withings' product has been held up from release by regulatory hurdles. While Withings ScanWatch was first introduced to the North American market at CES 2020 the device only obtained FDA clearance a year later in November 2021.

However, the company is confident regulatory approval will come faster this time and are aiming for a launch in the second half of 2022.

“We’ve learned a lot with the process of the ScanWatch, and gotten to know the team at the FDA quite a bit better. I feel we’re on the path to have [the Body Scan] on a reasonable time frame,” Withings chief medical officer Shikha Anand told The Verge.