Dexcom Inc. (NSDQ:DXCM) won FDA approval for next-generation continuous glucose monitor, news that preceded a nearly 7% drop in DXCM shares.
The San Diego, Calif.-based medical device company won U.S. market approval for its latest generation continuous glucose monitor, which represents "the most-advanced CGM system available," according to a company statement.
The also device features enhanced accuracy, an LCD color display, a smaller profile and a unique "hypo alert" setting that provides increased security.
Clinical trials found that the new system boasts a 19% improvement in overall accuracy as well as improvements in ease of use when compared with the company’s earlier-generation Seven Plus systems.
"Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view," Dexcom CEO Terrance Gregg said in prepared remarks. "The Dexcom G4 Platinum fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance."
Dexcom earlier this year won CE Mark approval in the European Union for the G4 Platinum, shortly after the device maker announced a partnership with the Juvenile Diabetes Research Foundation to develop a wireless transmission system to send data from a continuous glucose monitor to an "artificial pancreas."
"Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years," according to a Dexcom statement. "Although they remain an essential part of a comprehensive diabetes management program, finger stick meters are inherently limited by the fact that, like a photograph, it only provides data for the specific moment in which the measurement is completed; it doesn’t show whether glucose is going up or down – or how fast."
The news, announced yesterday, was followed by a 6.9% slide in DXCM trading. Shares, which opened at $14.72 yesterday, were trading at $13.73 as of about 12:50 p.m. today.
