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

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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.

Regulatory Roundup

Masimo lands FDA clearance for Pronto-7 system
Irvine, Calif.-based Masimo (NSDQ:MASI) landed 510(k) clearance by the FDA for its Masimo Pronto-7, a handheld device for noninvasive spot-checking of hemoglobin, spO2, pulse rate and perfusion index. Read more

Biomet wins FDA nod for 2 devices
Orthopedic and biotech device maker Biomet Inc. won clearance by the FDA for its Comprehensive segmental revision system and its E1 humeral bearing for use with its Comprehensive reverse shoulder system. The SRS system is specifically designed to address bone deficiency after cancer treatments. Read more

FDA grants 510(k) clearance to Varian planning system
The federal watchdog agency granted 510(k) clearance to Palo Alto, Calif.-based Varian Medical Systems for a new radiotherapy treatment planning tool designed to work with its Eclipse treatment planning software. Read more

Ortho Kinematics’s KineGraph VMA system lands FDA clearance
Austin, Texas-based Ortho Kinematics landed FDA approval for its KineGraph vertebral motion analyzer system. The KineGraph VMA is designed to improve the flexion/extension x-ray, a test routinely prescribed by spine doctors. Read more

Dehaier Medical wins CE Mark
Dehaier Medical Systems landed CE Mark approval to sell its sleep diagnostic devices and air compressors in Europe. The compressors are already available in Republic, Hungary, Kyrgyzstan, Pakistan, Ukraine, and the Philippines. Read more

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