Withings gets FDA nod for AFib-detecting wearable, taking on Apple

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 yet to publish the data. The French consumer electronics company joins Apple, Fitbit and Samsung in a crowded AFib market.

Dive Insight:

U.S. consumers who want wearables capable of detecting AFib were once largely limited to Apple devices. AliveCor created the category with its KardiaBand wristband attachment for Apple Watch, only for Apple to incorporate AFib capabilities into subsequent versions of its wearable device and drive the ECG accessory off the market.

New options have arrived over the past year, with Fitbit introducing Sense and Samsung adding an ECG to its Galaxy Watch3 and Galaxy Watch Active2. Samsung has since changed its range but retained the ECG.

Withings entered the European market last year but was kept out of the U.S. due to the need to receive FDA clearance for the ECG function of ScanWatch. This week, Withings revealed FDA has granted 510(k) clearance for the device, positioning it to start selling it in the U.S. next month.

The company contends that ScanWatch is the first wearable to simultaneously be cleared to record ECG and record blood oxygen level measurements.

At $279, ScanWatch undercuts the price of the latest Apple Watch, which is launching this month at $399. Apple sells cheaper versions of its watch, at $199 and $279, but those models lack ECG features needed to detect AFib. ECG capabilities are available on sub-$300 devices from Fitbit and Samsung.

It is currently unclear how ScanWatch's AFib-detection capabilities compare to those of Apple Watch and the other devices. Studies have found ScanWatch measures blood oxygen levels with “adequate accuracy at a clinical grade” and delivers “mixed results” compared to the gold standard for sleep tracking. FDA was convinced enough by the ECG data to clear ScanWatch but publicly available evidence is currently limited.

Consumers that select ScanWatch over Apple Watch will miss out on many of the features of Apple's device. Withings calls ScanWatch a hybrid smartwatch, reflecting the fact it incorporates a limited set of smart features into the form of an analogue watch. ScanWatch is a traditional watch that monitors activity, heart rate, AFib, blood oxygen levels and breathing disturbances.

The design has enabled ScanWatch to boast a battery life of up to 30 days, compared to the one-day battery life of Apple Watch, but it remains to be seen whether the trade off between price, features and battery appeals to U.S. consumers.