Withings Announces FDA Clearance of its Highly Anticipated Body Scan Health Station

Withings S.A. (France) - Press Release: Withings Announces FDA Clearance of its Highly Anticipated Body Scan Health Station Body Scan connected health station helps users get a handle on health with the ability to measure health vitals including Segmental Body Composition, Electrodermal Activity alongside a 6-lead medically cleared ECG via Withings Scan Monitor 2.0 (1).

Withings, the pioneer of the connected health movement, today announced that its revolutionary Body Scan Connected Health Station has received FDA clearance, via Withings Scan Monitor 2.01 and will be available this fall in the US priced at $399.95.

Body Scan with Withings Scan Monitor 2.0 is the world’s first health station to receive FDA clearance for the detection of atrial fibrillation through the acquisition of a 6-Lead ECG.

Body Scan provides daily analysis of biomarkers associated with common health conditions. With the ability to monitor segmental body composition, heart rate, and vascular age, it further advances the smart scale category. With measurements that will detect atrial fibrillation via a 6-lead ECG and also assess nerve activity, Body Scan goes beyond weight management to become an unprecedented in-home connected health station that can help users take proactive control over their health.

Winner of three CES 2022 Innovation Honoree Awards, Body Scan will also allow users to access coaching, clinical specialists and personalized, holistic plans in-app to help them reach their health goals. 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.

Body Scan consists of a single high strength tempered glass platform with an integrated retractable handle.

Body Scan contains four weight sensors and 14 ITO electrodes within the platform and 4 stainless steel electrodes in the handle for 6-lead ECG and segmental body composition analysis. It features a long-life rechargeable battery that offers 12 months of use and includes a large high resolution 3.2” LCD color screen that displays stats.

“Withings created the connected health category back in 2009 and today is proud to be the number one selling smart scale manufacturer in the United States, helping millions of users manage their weight,” said Eric Carreel, Withings Founder and President. “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. 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.”

Best-in-class weight monitoring and segmental body composition:

Body Scan will provide a precise (accurate to 0.1lbs / 50 grams) weight management experience thanks to its advanced weight sensors and unique retractable handle form factor. For the first time, a Withings scale integrates the breakthrough technology of segmental body composition allowing a never-seen level of precision for body composition monitoring.

Body Scan will also be able to measure Basal Metabolic Rate (BMR). BMR is the number of calories the body burns at rest, and it provides valuable information about the user's overall metabolic health. By measuring BMR, users can better understand their overall health and make informed decisions about their diet and exercise. The connected health station also uses this to calculate metabolic age, comparing how many calories a body burns at rest with others in an age group.

With electrodes placed in the base of the device and in the handle, Body Scan uses multi-frequency Bioelectrical Impedance Analysis (BIA) to measure overall body composition. It measures whole-body fat and water percentage, visceral fat, muscle and bone mass and provides readings for individual body parts, including torso, arms, and legs.

A very low level, safe electrical signal is sent from the electrodes on the scale and within the handgrip. Withings’ scientifically developed algorithm identifies resistance, known as impedance, to measure precise body composition in less than three seconds.

Often used by health experts and sports professionals, segmental body composition allows the smallest changes in body composition to be identified and monitored over time. Doing so identifies fat mass distribution, informs users of potential health risks associated with localized fat findings, and efficiently spots muscle imbalances. Withings democratizes this technology bringing it out of the sports lab and into the home.

Electrodermal Activity Monitoring:

Developed with experts from Impeto Medical, Body Scan will track sweat gland activity in the feet and provide daily assessment of small nerve activity. The measurement is designed to be performed in under 20 seconds by applying a small direct current via the electrodes located in the plate. It will provide a reading as an easy-to-understand score (computed from an Electrochemical Skin Conductance) delivered to the user via the device screen and the Withings App.

Sweat is triggered by the small nerves that are innervating the sweat glands. Sudomotor function can be evaluated by measuring the ability of the feet sweat glands to release chloride ions in response to an electrical stimulus. An impaired sudomotor function is a sign of reduced sweat gland innervation linked to a degeneration of small nerve fibers.

Lifestyle changes, such as healthy eating and getting regular activity, can be effective in improving nerve activity for a healthy lifestyle. To help users adopt healthy habits and affect change, the Withings app also provides access to actionable insights and personalized plans.

Every Day At Home Heart Health:

With cardiovascular conditions often linked to weight issues, Body Scan is designed to seamlessly offer a variety of cardiovascular measurements at every weigh-in. The upcoming features include: heart rate, ECG recordings, and vascular age.

Body Scan via Withings Scan Monitor 2.01 will record a 6-lead ECG via two sets of electrodes located on each side of the handle and one within the base of the scale. The proprietary embedded algorithm is designed to identify and track heart patterns associated with atrial fibrillation, allowing results to be displayed directly on the device’s LCD screen and the accompanying app. Readings can be stored to show trends over time and shared with medical professionals from the app.

Vascular Age will provide a daily, easy-to-understand assessment of arterial health and overall wellness. It accomplishes this by showing people how their cardiovascular health compares to the norms expected within their age bracket, using an estimate of their inner vascular age. Vascular Age is a patented technology developed by Withings.

Availability:

Developed by doctors specializing in cardiovascular, neurologic, and metabolic conditions, Priced at $399.95, Body Scan comes in black and will be available from the end of September 2023. Body Scan will come with a three-month subscription to Withings+ the health improvement programs available in the free Withings app.

About Withings:

Withings created the first smart scale in 2009 and has been the pioneer in connected health ever since. Its clinically validated and multi award-winning range is used by millions worldwide, and includes smart scales, hybrid watches, blood pressure monitors, sleep analyzers and more. The team of engineers, data scientists, and healthcare professionals at Withings work alongside clinical experts to make it possible to take medical-grade measurements at home. Withings was the first to bring measurements for pulse wave velocity and electrodermal activity into the home – finding ever more precise ways to measure our health. Withings Health Solutions, its dedicated division serving healthcare professionals across chronic disease prevention and management, remote patient monitoring, clinical research and more helps bridge the gap between patients
and their care teams.

Withings is dedicated to creating a world where people can see their path to better health, and feel supported to pursue it using devices designed to fit beautifully into daily life, supported by information that unlocks long-term health insights and offers programs to create meaningful change.

About Impeto Medical:

Impeto Medical is a French company created in 2005 specializing in the research, development, production and sales of innovative medical devices, especially in the field of detection and monitoring of peripheral neuropathies.

With more than thousands of Sudoscan products sold worldwide, Impeto Medical sets a new standard in the field of detection and monitoring of small fiber neuropathies from the doctor's office, particularly important for the prevention of serious complications such as diabetes and several neurological diseases. For the very first time, Sudoscan is integrated into an in-home device allowing the general public to have a comprehensive result of their nerve activity through a simple weight-in. As of November 20, 2021, Impeto Medical's activities have been completely sold to Withings company.

(1) Withings Scan Monitor 2.0 is the FDA cleared device name of Withings Body Scan when the ECG function has been activated by the user. Currently Withings Scan Monitor 1.0 allows ScanWatch 1 to enable an on-wrist 1-lead ECG.

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