FDA Grants Breakthrough Device Designation for Dexcom Hospital CGM System

Rhea-AI Summary

Dexcom (NASDAQ:DXCM) has received Breakthrough Device Designation from the FDA for its continuous glucose monitoring (CGM) system, aimed at improving glycemic management in hospital settings. This designation accelerates the regulatory review process, enabling faster market access for the technology. In prior studies involving over 800 patients during the pandemic, Dexcom CGM demonstrated enhanced glucose control without increased hypoglycemia risk. Experts anticipate that this designation will significantly advance in-patient care capabilities.

Positive

• FDA granted Breakthrough Device Designation for Dexcom CGM, enhancing regulatory review.
• Previous studies show Dexcom CGM improves glucose control without hypoglycemia risks.

Negative

• None.

• 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

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.

“During the COVID-19 pandemic, the FDA allowed Dexcom CGM to be used in hospitals to help health care providers manage patient glucose levels,” said Gil Rivas, vice president, general manager of hospital at Dexcom. “What started as a response during the pandemic has shown promise as a better alternative to fingerstick blood glucose tests with greater quality of care and patient satisfaction.”

About DexCom, Inc.

Dexcom, Inc. empowers people to take control of diabetes through innovative continuous glucose monitoring (CGM) systems. Headquartered in San Diego, California, and with operations across Europe, Dexcom has emerged as a leader of diabetes care technology. By listening to the needs of users, caregivers, and providers, Dexcom simplifies and improves diabetes management around the world. For more information about Dexcom CGM, visit www.dexcom.com.

^* For a list of compatible devices, visit www.dexcom.com/compatibility.

^† If your glucose alerts and readings from the G6 do not match symptoms or expectations or you’re taking over the recommended maximum dosage amount of 1000mg of acetaminophen every 6 hours, use a blood glucose meter to make diabetes treatment decisions.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220301006079/en/

Media Contact

James McIntosh

619-884-2118

james.mcintosh@dexcom.com

Investor Contact

Sean Christensen

858-203-6657

sean.christensen@dexcom.com

Source: DexCom, Inc.

FAQ

What is the Breakthrough Device Designation for Dexcom CGM?

The Breakthrough Device Designation enables faster regulatory review and market access for Dexcom's CGM technology in hospitals.

How does Dexcom CGM improve patient outcomes in hospitals?

Dexcom CGM provides real-time glucose monitoring, which facilitates better glycemic management and enhances patient safety.

When was the Breakthrough Device Designation granted to Dexcom?

The FDA granted the Breakthrough Device Designation to Dexcom's CGM technology as announced in the recent press release.

What are the benefits of using Dexcom CGM in a hospital setting?

Benefits include improved glucose control, reduced need for fingerstick tests, and greater patient satisfaction.

What studies support the use of Dexcom CGM in hospitals?

Studies conducted over seven years, including more than 800 patients during the COVID-19 pandemic, support the efficacy of Dexcom CGM in improving glucose levels.