Healthcare Industry News: Dexcom
News Release - August 29, 2006
DexCom Receives FDA Approval for DM(TM) Consumer Data ManagerSoftware for Patients to Download Data From STS(TM) Continuous Glucose Monitoring System
SAN DIEGO--(HSMN NewsFeed)--Aug. 29, 2006--Dexcom, Inc. (NASDAQ: DXCM ) announced today that it has received approval from the Food and Drug Administration (FDA) for its DM(TM) Consumer Data Manager, a software program that allows people with diabetes to download the data from their Dexcom STS(TM) Continuous Glucose Monitoring Systems onto their personal computers. The software enables patients to download and view up to 30 days of historical glucose trends and patterns.
"We are very pleased to begin providing the Dexcom DM Consumer Data Manager, as this was one of top requests from our customers for additional features for the STS Continuous Glucose Monitoring System. The software was designed to be easy to use and we are hopeful the software will help patients gain better insight into their diabetes," said Tae Andrews, Dexcom's Vice President of Marketing. "We are committed to providing leadership in the continuous glucose monitoring category and to continued improvement of our STS platform. Since the launch of our STS Continuous Glucose Monitoring System in March 2006, we have introduced Health Care Professional Patient Manager software and filed a PMA-Supplement with the FDA for our second generation 7-day STS Continuous Glucose Monitoring System."
About Dexcom, Inc.
Dexcom, Inc., headquartered in San Diego, California, is developing and marketing continuous glucose monitoring systems for people with diabetes.
Cautionary Statement Regarding Forward Looking Statements
Dexcom is a medical device company with a limited operating history. The company received approval from the FDA for its STS continuous glucose monitor on March 24, 2006, and has only recently launched the sale of this product throughout the United States. Successful commercialization of the company's products is subject to numerous risks and uncertainties, including a lack of acceptance in the marketplace by physicians and patients, the inability to manufacture products in commercial quantities at an acceptable cost, possible delays in the company's development programs, the inability of patients to receive reimbursements from third-party payors and inadequate financial and other resources. Certain of these risks and uncertainties, in addition to other risks, are more fully described in the company's quarterly report on Form 10-Q for the period ending June 30, 2006, as filed with the Securities and Exchange Commission on July 21, 2006.
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