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Home » Diabetes: Abbott lands FDA win for touch-screen glucose monitor | Regulatory Roundup

Diabetes: Abbott lands FDA win for touch-screen glucose monitor | Regulatory Roundup

March 9, 2012 By MassDevice staff

regulatory roundup

 Abbott lands FDA clearance for Freestyle InsuLinx blood glucose monitoring
Abbott (NYSE:ABT) won 510(k) clearance from the FDA for its FreeStyle InsuLinx blood glucose monitor, its first to include a touch-screen interface, automated logbook and personalization features.

The device, which won CE Mark approval in the European Union in May 2011, will be on the market in the U.S. in the coming months, according to a press release.

The next-generation Freestyle InsuLinx system is USB-compatible and can provider users and caregivers with reminders, messages and reports.

The Abbott Park, Ill.-based health care leviathan was trading 42 cents higher at $57.91 as of about 3 p.m. today.  Read more

Avedro files new drug application for VibeX corneal cross-linking treatment

Hospira wins clearance for Symbiq 3.13 infusion pump

Icon Interventional lands CE Mark for Nuloy coronary stent system

Filed Under: 510(k), News Well Tagged With: Abbott, Avedro Inc., Hospira Inc., Icon Interventional, Regulatory Roundup

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