The US Food and Drug Administration (FDA) has cleared Withings’ ScanWatch wearable to record SpO2 (oxygen saturation) and electrocardiogram (ECG) measurements. Priced from $279, it will be available in North America beginning November 2021.
Mathieu Letombe, CEO of Withings, says in a release, “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 at night, that can be signs of 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, it has been used in a study to monitor COVID patients remotely in German hospitals.
With FDA clearance of its SpO2 functionality, ScanWatch can be used to monitor blood oxygen levels and can be used to help detect if someone is experiencing issues from respiratory disorders such as COPD or COVID. ScanWatch can also detect the presence of nighttime breathing disturbances (a sign of sleep apnea) with an algorithm that analyzes blood oxygen levels, heart rate, movement, and respiratory rate, all collected via the accelerometer and optical sensors.
In addition, ScanWatch provides sophisticated sleep monitoring and analysis of sleep patterns, including the length, depth, and quality of sleep, and can wake users up with a gentle vibration at the best time of their sleep cycle.
ScanWatch can detect if a user has AFib thanks to its ability to take a medical-grade ECG on-demand. The device can monitor heart rate through its embedded PPG sensor, alerting the user to a potential heart event even if they don’t feel palpitations. In addition, when ScanWatch detects an irregular heartbeat through its heart rate sensor, it will prompt the user to record an ECG in just 30 seconds via the watch display.
ECG readings are displayed in the accompanying Withings Health Mate app where users can choose to send readings to their doctor.
ScanWatch connects with the free Health Mate app, which provides data and insights and can schedule activity reminders, set goals, and manage achievements. In addition, Health Mate can be paired with more than 100 third-party apps, including Apple Health, Google Fit, Strava, and MyFitnessPal.