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Abbott wins FDA approval of much-anticipated insulin-monitor app
[NEW YORK] Abbott Laboratories won US approval for its FreeStyle LibreLink diabetes-monitoring app, giving users a way to keep track of their glucose levels from their iPhones.
The app works with Abbott's FreeStyle Libre glucose sensors, which have rapidly become some of the top-selling medical devices in the US. It is likely to be a welcome addition for millions of customers who currently rely on separate pocket-sized gadgets to read their results. Rivals Medtronic Plc and DexCom Inc already had smartphone capability for their glucose systems.
The approval of the app by the Food and Drug Administration was announced by Abbott on Thursday.
In October, Abbott introduced alarms that let Libre users know when their glucose levels are too high or too low. FreeStyle LibreLink apps for Apple Inc's iPhone and Android devices have been available in Europe since February 2018, with more than 250,000 downloads. Service for US Android devices is still under development.
The app, free to download in the App Store, enables users to instantly capture and view their real-time glucose levels, assess their eight-hour glucose history, and see a directional arrow indicating how their glucose is changing, according to the company. The Libre system reads glucose levels through a sensor worn on the back of the upper arm, eliminating the need for finger-pricking except in special circumstances.
Abbott exceeded analysts' expectations last month when it reported results for the third quarter, with Libre driving a 37.4 per cent increase in sales for the company's diabetes unit. Its shares have risen about 21 per cent this year through Wednesday's close.