Alphabet's Verily receives FDA clearance for wearable medical device with electrocardiogram feature

Source: Xinhua| 2019-01-19 06:26:10|Editor: Chengcheng
Video PlayerClose

SAN FRANCISCO, Jan. 18 (Xinhua) -- Verily Life Sciences, LLC, a research group of Google's parent company Alphabet Inc., said Friday that it has obtained clearance from federal regulators for its wearable medical device equipped with on-demand electrocardiogram (ECG) technology.

Verily said the clearance from the U.S. Food and Drug Administration (FDA) allows its wearable Study Watch to be registered as a Class II medical device for its on-demand ECG feature.

"Specifically, the FDA-cleared Study Watch is a prescription-only device intended to record, store, transfer and display single-channel ECG rhythms, and is indicated for use by healthcare professionals, adult patients with known or suspected heart conditions and health conscious individuals," said the company, which was formerly Google Life Sciences before December 2015.

The company, which spun off from a division of Google X research lab, became an independent subsidiary of Alphabet in October 2015 and was renamed Verily two months later.

Unlike common consumer-facing Wear OS-powered wearable devices, Study Watch is specifically designed to help doctors and adult patients to gather vital information for medical studies of conditions such as cardiovascular or Parkinson's disease.

With built-in biometric, environmental and movement sensors, Study Watch helps people stay healthy and adapt with diseases.

"The ability to take an on-demand, single-lead ECG, can support both population-based research and an individual's clinical care," Verily said.

ECG is a measurement of the electrical activity of the heart and is useful in diagnosing a myriad of heart conditions.

"Receiving this clearance showcases our commitment to the high standards of the FDA for safety and effectiveness and will help us advance the application of Study Watch in various disease areas and future indications," said the Alphabet's company.

The FDA clearance offers Google's parent company a further step to tap into the profitable health care market.

TOP STORIES
EDITOR’S CHOICE
MOST VIEWED
EXPLORE XINHUANET
010020070750000000000000011100001377559381