The French company is promoting its ScanWatch as the first wearable device to receive FDA clearance for both atrial fibrillation detection through medical grade ECG and measuring SpO2 levels from the wrist.
The US Food and Drug Administration clearedWithings’ ScanWatch smartwatch to detect atrial fibrillation and measure blood oxygen, the Issy-les-Moulineaux, France-based company announced on 12 October.
Other wearable devices marketed to consumers, including the Apple Watch, can measure blood-oxygen saturation (SpO2) and have FDA-cleared electrocardiogram (ECG) functions, but Withings is touting ScanWatch as the first wrist-worn device to simultaneously receive FDA clearance for
The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.
The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.
States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.
