MedTech Dive October 13, 2021
Nick Paul Taylor

Dive Brief:

  • Withings has received FDA clearance for a watch it says is capable of detecting atrial fibrillation through a medical-grade ECG and measuring blood oxygen levels from the wrist.
  • The ScanWatch combines an analogue watch face with activity and health tracking features more typically found on digital smartwatches. The AFib capabilities put Withings up against Apple Watch but in most other regards the devices are very different. Apple’s Series 4 Apple Watch in 2018 became the first FDA-cleared consumer wearable to have ECG capabilities.
  • Withings began a clinical trial to test the ability of the watch to automatically classify atrial fibrillation and normal sinus rhythm late in 2019. The study supported the 510(k) clearance but Withings has...

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Topics: Digital Health, FDA, Govt Agencies, Technology, Wearables
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