Alphabet announced that the Verily Study Watch has been cleared by the FDA as a medical device that can record, transfer, store and display ECG data
Google parent company Alphabet unveiled Verily Study Watch in 2017, in which the company described it as a smartwatch designed specifically for capturing health data from clinical study participants. Since its launch, the watch has been put to good use in the months, including in studies involving Parkinson’s disease. The wearable features an on-demand ECG device and has now earned FDA approval as a Class II medical device.
The company announced that the Verily Study Watch has been cleared by the FDA as a medical device that can record, transfer, store and display ECG data. The watch is meant for use by adult patients in conjunction with a medical professional and is only available by prescription.
Having simple access to on-demand ECG information is ideal for both researchers who may use them during heart-related studies and for patients with cardiac issues. That has been the case with some on-going studies, including Aurora and Project Baseline.
Existing work also includes looking into, whether data gathered by mobile health devices like this can be useful in the patient-doctor care process. The new FDA clearance adds an element of legitimacy to Verily’s device as an ECG as it 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, to the Apple Watch Series 4. It has built-in ECG functionality. Johnson & Johnson revealed a new study involving the Apple Watch, including whether the wearable’s data could improve health outcomes for people with AFib.