FDA Clears Withings’ latest medical device, an ECG-Equipped Smart Scale for Afib Detection

The utilization of electrocardiogram (ECG) technology has expanded significantly across medical devices, ranging from portable gadgets to smartwatches and bathroom scales. Withings, a notable player in health technology, has taken a substantial step with its Body Scan smart scale, integrating a six-lead ECG and an array of health analysis features. 

Eric Carreel, Withings’ founder and president, envisions the Body Scan smart scale as a tool to elevate routine weigh-ins into comprehensive home health assessments. This advancement aims to provide users with access to holistic health data and personalized health programs crafted by medical professionals. The goal is to enable informed actions based on medical-grade insights, supporting the management of lifestyle choices and chronic health conditions through in-home health experiences.

Withings labels the device a “connected health station” and plans to launch it in the United States soon. The package includes the medical device and a three-month subscription to the Withings+ health improvement program, accessible through a dedicated app.

The Body Scan smart scale collects ECG readings through three electrode sets—two flanking the scale’s retractable handle and one embedded in its base. Using an advanced algorithm, the device analyzes heart readings to detect possible signs of atrial fibrillation—an irregular heartbeat. The results are displayed on the scale’s LCD screen and integrated into the accompanying Withings app.

The medical device’s capabilities extend to assessing small nerve activity—an essential aspect of regulating involuntary functions in cardiovascular and digestive systems. During a 20-second reading, the device emits a mild current to the user’s feet, while sensors monitor responses from sweat glands. These responses provide insights into the health of small nerve fibers, potentially indicating conditions such as peripheral nerve damage, diabetes, or Parkinson’s disease. The Withings app offers guidance on improving nerve activity through dietary adjustments, physical activity, and lifestyle modifications.

This electrodermal activity monitoring technology originated from Withings’ acquisition of Impeto Medical, the manufacturer of Sudoscan nerve-assessing sensors, in 2022.

In addition to other features, the Body Scan smart scale reports body weight readings. Its sensors and retractable handle ensure accuracy within 0.1 pounds or 50 grams. The device offers a comprehensive analysis, calculating the user’s basal metabolic rate, metabolic age, and delving into body composition. The system determines proportions of water, fat, muscle, and bone in the user’s body, providing insights for different body regions.

By merging ECG capabilities with features assessing heart health, nerve activity, and body composition, the device facilitates empowered health monitoring. This empowers users to make informed decisions about their well-being, potentially leading to an enhanced quality of life.