Alphabet’s Verily ECG watch gets FDA approval as medical device

Brittany A. Roston - Jan 18, 2019, 7:45 pm CST
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Alphabet’s Verily ECG watch gets FDA approval as medical device

Alphabet unveiled Verily Study Watch in 2017, describing it as a smartwatch designed specifically for capturing health data from clinical study participants. The watch has been put to good use in the months since its launch, including in studies involving Parkinson’s disease. The wearable features an on-demand ECG device and has just earned FDA approval as a Class II medical device.

The Verily Study Watch has been cleared by the FDA as a medical device that can record, store, transfer, and display ECG data, the company announced today. The watch is only available by prescription and is meant for use by adult patients in conjunction with a medical professional.

Having simple access to on-demand ECG information is ideal for both individual patients with cardiac issues and by researchers who may use them during heart-related studies. That has been the case with some on-going studies, including Project Baseline and Aurora.

Existing work includes looking into whether data gathered by mobile health devices like this can prove useful in the patient-doctor care process. The new FDA clearance adds an element of legitimacy to Verily’s device as an ECG and paves the way for doctors to prescribe the smartwatch to their patients.

Consumers interested in passively monitoring their heart rhythms sans prescription will have to look elsewhere, though, namely to the Apple Watch Series 4, which has built-in ECG functionality. Johnson & Johnson revealed a new study involving the Apple Watch today, including whether the wearable’s data could improve health outcomes for people with AFib.


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