Tags: Diabetes | diabetes | glucose | monitoring | system | fda | dexcom

FDA Approves Diabetes Glucose-Monitoring System

Image: FDA Approves Diabetes Glucose-Monitoring System
(Copyright Dreamstime)

Tuesday, 27 March 2018 11:53 PM

The U.S. Food and Drug Administration on Tuesday approved DexCom Inc.'s monitoring system to check blood sugar levels in children and adults suffering from diabetes, which can be used along with devices such as insulin pumps.

The company's shares rose as much as 3.7 percent to $72.75 in regular trading on Tuesday and closed at $69.99.

This is the first glucose monitoring system permitted by the agency that can be used with other compatible medical devices, the FDA said.

A previous version of DexCom's monitoring system had received FDA approval in 2016 but was not designed to be used with other devices.

Glucose monitoring systems in the past were evaluated through the FDA's premarket approval pathway, the most rigorous review meant for "highest risk" Class III devices.

The FDA's decision classifies the monitoring system as Class II, and would help future developers of such systems bring their products to market in "the least burdensome manner possible," the regulator said.

© 2018 Thomson/Reuters. All rights reserved.

   
1Like our page
2Share
Health-News
The FDA has approved DexCom Inc.'s monitoring system to check blood sugar levels in children and adults suffering from diabetes, which can be used along with devices such as insulin pumps.
diabetes, glucose, monitoring, system, fda, dexcom, blood sugar
159
2018-53-27
Tuesday, 27 March 2018 11:53 PM
Newsmax Inc.
 

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved