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FDA Clearance for Tandem Remote Software Tool


The tool will let pump users get updates of new features in between replacement of their hardware.

Tandem Diabetes Care has received FDA clearance for a tool designed to allow remote updates for its insulin pump software.

The Tandem Device Updater, which is both Mac and PC compatible, received clearance Thursday. The tool will be first used to deploy new software for in-warranty t:slim pumps purchased before April 2015, according to a statement from the manufacturer.

“This clearance, combined with the flexibility provided by our pumps’ touchscreen interfaces, uniquely positions Tandem as the only insulin pump company with the ability to provide its customers access to new and enhanced features, separate from the typical multi-year warranty hardware replacement cycle,” said Kim Blickenstaff, Tandem’s president and CEO.

The rollout of the updater will go first to early t:slim pump users in a series of test groups, followed by broader availability in late 2016, according to the statement.

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