DexCom (San Diego) reported late last week that it has received FDA approval for Seven, a seven-day STS Continuous Glucose Monitoring System.

Seven is the company’s second-generation device in the continuous glucose monitoring category — but don’t expect it to be the last.

“As much as anything we believe that next-generation products with improved performance are absolutely key to the continued category growth in continuous glucose monitoring,” Andrew Rasdal, DexCom’s president/CEO said during a web cast presentation at the Bank of America 2007 Healthcare Conference in Las Vegas last week.

“This particular product is a next-generation product [but] by not means are we done with the evolution of the technology and the product, but it’s the next step forward.”

Rasdal also pointed out that the approval of Seven comes only about a year after the company’s original approval for the STS.

The company head also called the FDA thumbs-up a “very strong approval,” noting that no conditions were attached to it. “That, I think, demonstrates what we continue to value — as a cooperative, productive relationship with the FDA — in bringing forth new products we hope will improve the lives of people living with diabetes on a daily basis.”

DexCom hopes to begin a limited launch of the next-generation Seven product near the end of this quarter, Rasdal said, with a full launch of Seven through the third quarter.

“It is the first continuous glucose monitoring product to be approved for up to seven days of continual use,” according to Rasdal. “All others that have been previously approved have been for three days of use,” he said, adding: “We have a waterproof claim with this — it eliminates the inconvenience of the shower patch that people are required to use today.”

In addition to the waterproof claim, Rasdal said the company also took the needle size down further in the second-generation device so that it is easier and more comfortable to insert.

In other company news, DexCom also reported FDA approval of its DM2 Data Manager software designed to allow healthcare professionals and patients to download continuous glucose data from their receivers to their computers. The DM2 Data Manager is DexCom’s second-generation download software, with new tools and analytical capabilities to provide further insight into their diabetes and facilitate more appropriate care, the company said.

“This is something that’s been consistently requested by healthcare professionals and patients,” Rasdal said.

DexCom expects to launch the DM2 in conjunction with Seven.

The company said it would schedule a conference call “at a later date” to discuss the approval and product plans in more detail.

In April DexCom reported that the Centers for Medicare and Medicaid Services issued a positive preliminary decision for DexCom to develop Healthcare Common Procedure Coding System codes for its devices, bringing the company a step closer to gaining reimbursement for its continuous glucose monitoring devices. The codes describe specific healthcare items and procedures and are necessary for processing health insurance claims.

The company expects a final decision to be published in late October or early November. If the code is issued, DexCom expects the HCPCS codes to go into effect Jan. 1 (Medical Device Daily, April 25, 2007).

Diabetes afflicts about 20 million people in the U.S., according to the Centers for Disease Control and Prevention (CDC; Atlanta). In the U.S., diabetes is the 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, according to DexCom.