The device will be the first FDA-approved health station that detects atrial fibrillation through a six-lead ECG. The device will go on sale in the US this Fall priced $400, nearly two years after the Body Scan was launched at CES 2022.
At the time the company said it was confident regulatory approval would come that same year, aiming for a launch in the second half of 2022.
However, in an interview with CET&D magazine this year Withings head of product Matthieu Menanteau recognised the slow pace of the US approval process compared to Europe, a problem that he blamed in part on the fact that approval is overseen by a single centralized regulator.
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.
BodyScan is a set of bathroom scales which does far more than just 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.
According to Withings, BodyScan will also allow users to access coaching, clinical specialists and personalized, holistic plans in-app. “Developed with specialists in cardiovascular, neurologic, and metabolic conditions, these programs will provide users with important insights based on well-known metrics and the ability to be connected with medical specialists in case of health concerns,” the company said in a press release.