A health monitoring watch being developed by Verily — an arm of Google parent company Alphabet — has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) as a medical device. This means that the device can legally be sold in the U.S. and that the FDA has found it safe and effective, which is important given fresh concerns over the accuracy of data from other wearables.
Verily, Alphabet’s life sciences research organization, has been working on a health watch for several years. The aim was to create an unobtrusive biosensing device that could be used to monitor the wearer’s health either for clinical or for research purposes. According to Verily, the device has now been developed and has been used by thousands of people as part of clinical research studies, and with the new FDA approval the devices can now be used for more research projects.
The research using the Verily Study Watch is focused particularly on cardiovascular health, which is the number one cause of death of both men and women in the U.S. According to Verily, the device has been cleared “as a Class II medical device for its on-demand ECG feature,” and is a “prescription-only device intended to record, store, transfer and display single-channel ECG rhythms.” The device is not necessarily meant for public use, but rather is intended to be used by health professionals and adult patients with heart problems who need to keep an eye on their heart health by monitoring ECG rhythms.
Current research using Verily includes Project Baseline, a longitudinal study that aims to collect health data from a large number of people to serve as a baseline for various health measures, in the long term using the data as a map of health for disease prevention. The health data being collected by Verily includes biometric data like ECGs and genomic and proteomic data, as well as traditional clinical data like electronic health records and medical images.
According to Michael V. McConnell, M.D., Head of Cardiovascular Health Innovations at Verily, “This work may ultimately give us insights into the utility of integrating mobile health data into the clinical care environment, and how these data can support the physician-patient relationship… Together, we are working towards a future where we can use devices, like the FDA-cleared Study Watch, to inform real-world, personalized care decisions and help us move to proactive healthcare.”
