Alphabet revealed Verily Study Watch in 2017, calling it a smart-watch that is designed specifically for capturing medical data from participants of a clinical study.
The smart-watch has been used effectively for a few months since its launch, including in clinical studies involving Parkinson’s disease. This wearable on-demand ECG smart-watch has just got the approval from the FDA, backing it as a Class II medical device.
The FDA approved Verily Study Watch is considered a medical device that is capable of recording, storing, transferring, and displaying ECG data, the Alphabet announced today.
The smart-watch is only available under a prescription and is intended for use by adult patients under the supervision of a healthcare professional.
It is ideal for people with heart or cardiovascular disease to have easy access to on-demand ECG data for further medical evaluation and intervention. That has also been the case with a few on-going studies, including Project Baseline and Aurora.
Medical devices like this can be of great help in the physician-patient care process. The FDA clearance also adds an element of legitimacy to Alphabet’s Verily Study Watch as an ECG device, which paves the way for physicians to prescribe the smart-watch to their patients who have pre-existing cardiac conditions.
Consumers who are interested in monitoring their heart rhythms have to get a prescription from their physicians to buy Verily Study Watch. Similar to this medical device, there is another Apple Watch Series 4 that has built-in ECG functionality.
Johnson & Johnson has revealed a new study about the Apple Watch today. It says such the wearables could improve health outcomes for patients with atrial fibrillation or arrhythmia.
Verily said the smart-watch’s potential to take an on-demand, single-lead ECG, can help both patients and physicians in implementing care.
This advanced medical device is already a cornerstone of several clinical research projects, Verily noted. It aims to gather medical data from around 10,000 different people. It can also help to collect more information about how to treat and prevent certain diseases.
Apart from cardiac health, the smart-watch could be useful in monitoring patients with a history of traumatic events and Parkinson’s disease.
The Verily Study Watch also has movement and environmental sensors, allowing the user to monitor how his/her body stays healthy and changes or adapts with a disease.
AliveCor has developed an ECG system where a wearable band will transmit data from one smartphone to another. It plans to produce a more accurate six-lead system, which could help detect more diseases.
The FDA approval for Verily Study Watch with an ECG function intensifies competition with other smart-watch manufacturers, including the Apple Watch’s ECG function (already approved by the FDA) and Withings’ recently launched, The Move ECG.
