WIRE)–Dexcom, Inc. (NASDAQ: DXCM) today announced that it has received CE
Mark (Conformité Européene) approval for its fourth generation continuous glucose
monitoring system, the Dexcom G4® system, enabling commercialization of the
Dexcom G4 system in the European Union and the countries in Asia and Latin
America that recognize the CE Mark.
The Dexcom G4 system is designed to help people with
diabetes better manage their diabetes and control their glucose levels. Widely
recognized as one of the leading causes of death and disability globally,
diabetes is a chronic disease with no known cure that afflicts an estimated 366
million people worldwide, according to the International Diabetes Federation. Diabetes
is a leading cause of adult blindness, end stage kidney failure and lower limb
amputations. People suffering from diabetes are also more significantly at risk
for cardiovascular disease and stroke.
“We are pleased to have CE Mark approval for the Dexcom
G4 system. Although we believe the Seven Plus is already the best sensor on the
market, we are especially proud of the Dexcom G4 system’s improved performance
and reliability, which is reflected in the G4 system data we recently presented
at the American Diabetes Association’s 72nd Scientific Sessions. We look
forward to working with physicians, nurses and diabetes educators to bring this
important new technology to patients around the world,” said Terrance H.
Gregg, Dexcom’s Chief Executive Officer. “We have been working diligently
to establish a launch plan with our network of distributors outside the United
States and plan to execute a phased launch of the G4 system in Europe during
the coming months,” added Mr. Gregg.
About Dexcom, Inc.
Dexcom, Inc., headquartered in San
Diego, California, is
developing and marketing continuous glucose monitoring systems for ambulatory
use by patients and by healthcare providers in the hospital.