Withings' ECG-equipped smart scale earns FDA clearance for afib detection

In recent years, electrocardiogram technology has become increasingly widely available, embedded into dedicated portable devices, smartwatches and, now, even bathroom scales.

The latter advancement comes courtesy of Withings, whose Body Scan smart scale is equipped with a six-lead ECG—among several other health-analyzing features—and is newly cleared by the FDA, according to a recent announcement (PDF) from the company.

“With Body Scan, we will turn the morning weigh-in into a sophisticated home health check with access to holistic health data and personal health programs created by medical professionals,” Eric Carreel, founder and president of Withings, said in the announcement. “We will empower our users with the ability to take meaningful actions based on medical-grade data, adding a new dimension to ongoing lifestyle and chronic condition management through the ultimate in-home health experience.”

The device, dubbed a “connected health station” by Withings, will begin its U.S. rollout at the end of September. It’ll retail for just under $400 and come with a three-month subscription to the app-based Withings+ health improvement program.

The smart scale collects ECG readouts via three sets of electrodes: two located on either side of the device’s retractable handle and one embedded in the base of the scale. Body Scan is equipped with an algorithm that analyzes the heart readings to flag possible signs of atrial fibrillation, with the results displayed both on the scale’s own three-inch LCD screen and in the accompanying Withings app.

Meanwhile, those data and other health information will be used to calculate a user’s “vascular age,” which compares how their heart health and overall wellness compare to the standards for their age group.

Beyond the heart, Body Scan can also assess a user’s small nerve activity, which has a hand in regulating some involuntary functions of the cardiovascular and digestive systems. During a 20-second reading, electrodes in the scale’s plate send out a small current to the feet, while sensors watch for a response from the sweat glands that may indicate degeneration among the small nerve fibers.

That degeneration may be linked to conditions including peripheral nerve damage, diabetes and Parkinson’s disease, but nerve activity can be improved through diet, activity and other lifestyle changes—which the Withings app can lay out for users if needed.

This electrodermal activity monitoring technology is a product of Withings’ early 2022 purchase of Impeto Medical, maker of the Sudoscan nerve-assessing sensors.

On top of those high-tech features, Body Scan also provides the weight readings of a typical scale. Thanks to its built-in sensors and retractable handle, Withings says the readings are accurate to within 0.1 pounds or 50 grams.

But, of course, the device also takes those readouts to the next level: In addition to reporting the user’s body weight, it also analyzes their basal metabolic rate and overall “metabolic age,” while the electrodes in the handle and base can be used to paint a picture of their body composition. In that three-second analysis, the system can determine what percentage of the user’s body mass is water, fat, muscle or bone, while also breaking down that composition for the torso, arms and legs alone.