ScanWatch from Withings receives FDA approval
November 24, 2021
PARIS, France – Withings – pioneers of the connected health revolution – has announced that ScanWatch, its globally-acclaimed and most medically advanced wearable, has received FDA clearance.
With state-of-the-art technology that can monitor heart rate, atrial fibrillation through ECG, breathing disturbances, blood oxygen levels through SpO2, sleep, and physical activity, it has already impacted countless lives around the world since its launch in Europe and Australia and is now also available in North America.
Aside from activity and workout tracking, ScanWatch is the first wearable to simultaneously be cleared to record ECG & SpO2 measurements.
“ScanWatch received three CES Innovation Awards when it was first announced in 2020 and we are thrilled to bring it to the United States following robust FDA scrutiny,” said Mathieu Letombe (pictured), CEO of Withings. “At Withings, our core mission is to create beautiful devices people choose to use and wear every day so the medical data they provide can make meaningful impacts on their lives.
“ScanWatch has been clinically validated to detect AFib and can aid in the detection of breathing disturbances that can be signs of respiratory issues such as COPD and sleep apnea. It is our most ambitious medical watch to date and has the potential to benefit millions of people.”
Developed with cardiologists and sleep experts, ScanWatch has been validated in two clinical studies. It has already impacted countless lives in Europe where it has also been used in a study to monitor COVID patients remotely in German hospitals. ScanWatch is designed with a stainless-steel case and durable sapphire glass watch face and features a large digital display as well as easy navigation through a newly created crown dial. Additionally, ScanWatch is water-resistant up to 5 ATM and features an exceptional battery life of up to 30-days.
Like all Withings devices, ScanWatch connects with the free Health Mate app, which provides data and insights and can schedule activity reminders, set goals, and manage achievements. Users can also choose to send ECG readings to their doctor or cardiologist through the app. In addition, Health Mate can be paired with more than 100 third-party apps, including Apple Health, Google Fit, Strava, and MyFitnessPal.
ScanWatch can be purchased in Canada through www.withings.com, Best Buy, and Amazon.
Established in 2008, Withings is a world leader in connected health technology. Its team of engineers, data scientists, and healthcare professionals have enthused everyday, elegant lifestyle objects with medical capabilities to efficiently track health vitals. Its range of medical-grade in-home devices can monitor more than 20 health parameters and are used daily by millions of people worldwide. Its portfolio of devices that includes connected scales, hybrid watches, smart thermometers, blood pressure monitors, and sleep trackers empower individuals to take back control of their health, track chronic diseases and detect under-diagnosed conditions. For more information, visit www.withings.com.