FDA Designates Dexcom’s Hospital CGM System a Breakthrough Device

DexCom has received a Breakthrough Device designation from the FDA for its Dexcom CGM continuous glucose monitor for use in hospitals.

The device uses a small, wearable sensor and transmitter to continuously send glucose levels wirelessly to a smart device, providing real-time data without the need for fingersticks.

The system also features customizable alerts and alarms to help avoid potentially dangerous low and high blood sugar events.

Hospital studies by the Scripps Whittier Diabetes Institute in San Diego over the past seven years have shown that “the device improves glucose control without any increased risk in hypoglycemia,” according to Athena Philis-Tsimikas, an endocrinologist and corporate vice president at the institute.