Withings scores FDA clearance for smartwatch ECG and SpO2 monitoring

"Roughly a year after the ScanWatch landed regulatory clearance in Europe, Withings finally received an FDA clearance for the wearable’s ECG and SpO2 monitoring features.

Customers in the U.S. can now use the ECG feature for atrial fibrillation detection (AFib). The watch was designed to alert users if AFib is suspected. Users can then use the tool to take a 30-second ECG reading.

The new clearance also enables SpO2 monitoring, which can check blood oxygen levels. According to the company, this measure can help detect respiratory disorders like COPD or COVID-19. The watch is also fitted with an algorithm that analyzes blood oxygen levels, heart rate, movement and respiratory rate in order to pinpoint night breathing disturbances, which is an indicator of sleep apnea.

Like previous Withings watches, the tool also lets users monitor their heart rate, sleep and fitness activity heart rate. The company is planning to roll the device out in North America in November and charging $279 for the tool.

THE LARGER TREND

According to the CDC, AFib is the most common type of heart arrhythmia. By 2030 the agency estimates that 12.1 million people in the U.S. will have the condition. AFib can increase a patient’s risk for stroke.

However, according to the CDC, the condition can be treated with medication and lifestyle changes.

Sleep apnea is also a common condition in the U.S. According to the Sleep Foundation, between 2% and 9% of adults in the US are estimated to have the condition. The condition is a risk factor for cardiovascular issues, such as high blood pressure, heart attack and heart disease.

“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,” Mathieu Letombe, CEO of Withings, said in a statement..." Lire la suite