Study Watch Receives FDA Approval

Verily has received FDA approval for its study watch. TrialSite News republishes its summary below for our readers. It is part of the digital health movement—making the way for patient-centric trials. Verily launched the Verily Study Watch as an investigative device for capturing health information from clinical research participants on April of 2017.  Since that point, the company reports that the watch has been used by thousands of participants in clinical research studies run not only by Verily, but also through their partners such as the following:

Project Baseline Study  

Aurora Study

Personalized Parkinson’s Project Study

Parkinson’s Progression Markers Initiative

With the move to patient-centric research, investigators not only leverage technology such as telehealth where patients don’t necessarily have to travel to a research center, but also digital health data capture tools such as the Study Watch. Unobtrusive biosensing through devices like Study Watch and other mobile health tools is an important new approach to understanding what happens in the body at any given moment in time, and can provide insights into how our bodies stay healthy or change and adapt with disease.One area of focus for Study Watch has been cardiovascular health, as heart disease remains the number one killer of men and women in the United States1. Most cardiovascular events are preventable and the American Heart Association (AHA) has a stated goal of advancing mobile health to enhance prevention and care2. The good news is there are well-understood signals that can indicate heart disease and the risk of a future event. The electrocardiogram, or ECG, is a measurement of the electrical activity of the heart and is useful in diagnosing a myriad of heart conditions.