After Apple, Google’s parent company Alphabet is working its way towards bringing health at the centre of its products. Now, the company’s health division Verily has reportedly received FDA 510(k) clearance for its Study smartwatch for an on-demand ECG feature.
The Study Watch, announced two years ago, is intended to be a test platform for the company to research how to best gather health data on a wearable device, The Verge reported.
The smartwatch already had the ECG feature, however, it didn’t receive clearance from the FDA. The feature is increasingly becoming a standard for a lot of manufacturers and FDA’s clearance for the feature in a Class II device is not for the actual efficacy of the device, but only that it is safe to use.
Alphabet’s Study Watch is a prescription-only device and is not meant to be a consumer smartwatch. The EKG feature on the Study Watch is intended to record, store, transfer, and display single-channel ECG rhythms.
Notably, the Apple Watch Series 4 has an FDA-approved ECG feature that began rolling early last month with the release of watchOS 5.1.2. To recall, the Apple Watch Series 4 was launched back in September, alongside the 2018 iPhone models. The ECG functionality was one of the highlighted features of the watch at launch, and within a day of its rollout, it managed to save a life.
The Apple Watch Series 4’s ECG feature is currently only available in the US, and offers a low heart rate notification, as well as an alert for atrial fibrillation (aka A-Fib). Apple at launch claimed it was the first ECG product available over the counter, directly to the customer. The results of the ECG app will be stored in the Health app on the connected iPhone, and can be shared in the form of a PDF file.