FDA approves Dexcom’s G5 Mobile CGM system for diabetes management

Dexcom, Inc. (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM) for patients with diabetes, announced today that the U.S. Food and Drug Administration (FDA) has approved its G5 Mobile CGM system as the first and only continuous glucose monitoring system that can be used to make daily diabetes treatment decisions without finger pricking. The new “non-adjunctive” indication expands use of the Dexcom G5 Mobile CGM system as a replacement to finger stick glucose testing for diabetes treatment decisions, positioning the device as the new standard of care in glucose monitoring for diabetes management. With the new label indication, the Dexcom G5 CGM System only requires two finger pricks per day for calibration.

“This approval is truly momentous for people like me with diabetes as we can now go up to 12 hours without a painful finger prick, we don’t have to carry a glucose meter everywhere we go, and we can make treatment decisions without lancing our fingers”

“The expanded indication for the Dexcom G5 Mobile CGM system is an astounding milestone for people with diabetes and it is a critical step to advancing diabetes technology that will drastically change diabetes management,” said Kevin Sayer, Dexcom President and Chief Executive Officer. “Now, people with diabetes who use the Dexcom G5 Mobile CGM system can make daily treatment decisions without having to perform confirmatory finger sticks. And basing their treatment decisions on a number, accompanied by information on speed and direction from the CGM, will greatly improve their decisions over the information provided by blood glucose meters.”

In July, an FDA selected panel of experts determined that the Dexcom G5 Mobile CGM system is safe, effective and the benefits outweigh the risks with the proposed indications for use. The FDA has followed the expert recommendation and made the Dexcom G5 Mobile CGM system the first and only CGM system in the U.S. to have a non-adjunctive designation. Dexcom’s CGM system is widely recognized as the most accurate and most popular CGM in the world.

“This approval is truly momentous for people like me with diabetes as we can now go up to 12 hours without a painful finger prick, we don’t have to carry a glucose meter everywhere we go, and we can make treatment decisions without lancing our fingers,” said Steven Edelman, MD, Founder and Director, Taking Control of Your Diabetes. “It completely changes the way that we manage our diabetes and gives us a chance to gain much better control of the disease without all of the pain and hassle of constant finger sticks.”

The approval is also the first step toward enabling people 65 and older with Medicare to access CGM, as non-adjunctive labeling is a requirement for Medicare coverage.

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