FDA approves DexCom's glucose monitoring system

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

(Reuters) - 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.

Reporting by Manas Mishra in Bengaluru; Editing by Shounak Dasgupta