FDA Grants Breakthrough Device Designation for Dexcom Hospital CGM System

• Dexcom CGM to be evaluated for performance in the hospital and for the potential of more effective glycemic management and improved patient outcomes in the hospital setting
• Breakthrough Device Designation from the FDA is a critical milestone for in-patient Dexcom CGM use
• This designation provides a more efficient and streamlined review pathway so innovative Dexcom CGM technology can get to the hospital market faster

Excerpt from the Press Release:

SAN DIEGO–(BUSINESS WIRE)–DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time continuous glucose monitoring (CGM) for people with diabetes, announced today the FDA has granted Breakthrough Device Designation for Dexcom CGM use in the hospital setting.

Dexcom CGM uses a small, wearable sensor and transmitter to continuously measure and send glucose levels wirelessly to a smart device^*, providing real-time glucose data without the need for fingersticks. ^† The system also offers customizable alerts and alarms to help avoid potentially dangerous low and high blood sugar events.

“In our extensive use of Dexcom CGM in our hospitals as part of exploratory studies over the last seven years, more than 800 of those patients treated during the pandemic, we have found that the device improves glucose control without any increased risk in hypoglycemia,” said Athena Philis-Tsimikas, M.D., endocrinologist and corporate vice president for the Scripps Whittier Diabetes Institute in San Diego. “Breakthrough Device Designation from the FDA could be transformative for using CGM for in-patient care in hospitals.”

The FDA’s Breakthrough Device Designation is designed to expedite the development and regulatory review of medical devices that hold the potential for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or condition. Breakthrough devices benefit from interactions with the FDA’s experts to efficiently address topics in a timely way.

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