Diabetes: Roche lands FDA nod for Accu-Chek Nano | Regulatory Roundup

January 12, 2012 By MassDevice staff Leave a Comment

Roche (PINK:RHHBY) won clearance from the U.S. Food & Drug Administration for its Accu-Chek Nano SmartView blood glucose monitoring system.

The Switzerland-based biotech builder’s no code meter is smaller than a credit card that allows patients to customize test reminders, pre and post meal markers and calculate their average glucose levels.

"It is easy-to-use and will help people with diabetes regularly check their blood glucose levels before making informed therapy and lifestyle adjustments," Marc Gibeley, head of Roche Diabetes Care North America said in prepared remarks. "We look forward to its launch later this year."

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The company plans to launch the Accu-Chek Nano to U.S. customers during the first half of 2012.

The new system is part of the same product line as the Accu-Chek Aviva and Accu-Chek Performa systems that have already been launched in Europe Union, Latin-America, Asia and the Pacific.

Roche recalled a member of the Accu-Chek family in early 2011 when it discovered that its Accu-Chek FlexLink Plus could under-deliver insulin when the tube that delivers the medicine becomes kinked.

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