At long last, Roche wins approval of Nano

Finally.

Roche Diagnostics Corp. this month won approval from the U.S. Food and Drug Administration for its Accu-Chek Nano SmartView blood glucose monitoring system.

The approval comes more than two years after FDA officials declined to approve a previous version of the Nano, which in rare cases generated inflated blood-sugar readings because it did not distinguish properly between the sugars glucose and maltose.

That left Roche bereft of its latest technology in the U.S. market, even as Nano devices sold well in Europe. Roche’s troubles with the Nano contributed to a stagnation in Roche’s sales of blood glucose monitors, which totaled $2.6 billion in 2010, according to the latest year-end data from San Francisco-based market research firm Close Concerns Inc.

"The Accu-Chek Nano meter is the newest advancement in Roche's more than 35-year commitment to bring state-of-the-art innovations to people with diabetes and their caregivers,” Luc Vierstrate, the global head of Roche Diabetes Care, said in a prepared statement. “This new system will help us to further leverage and enhance our position in this important market."

The Nano SmartView is designed to be easier to use for diabetics, who must test their blood multiple times per day to determine what they can eat and when they need to take a dose of medicine, such as insulin. It is about as wide and tall as a credit card, and does not, as earlier versions of Accu-Chek meters do, require patients to input a code to calibrate the meter before use.

It’s the second bit of good news for Roche’s diabetes business in as many months. In November, Roche announced it will partner with San Diego-based DexCom Inc. to incorporate its continuous glucose monitoring sensor with a wireless handheld device Roche is developing to help diabetics test their blood sugar and track their glucose levels throughout the day.

Continuous glucose monitoring is seen as the next wave of innovation in the blood glucose monitoring market, yet Roche has been running behind its competitors on getting such a product to market.