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Ear-Tube Insertion Moves To Physician Offices With Breakthrough Device

 
• By Elizabeth Orr

A device newly approved by the US FDA will allow physicians to insert ear tubes to treat recurrent ear infections in the office, eliminating the risks of general anesthesia. The Tubes Under Local Anesthesia (Tula) System was reviewed via the agency’s breakthrough device pathway.

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Tusker Medical has won US Food and Drug Administration approval for its Tubes Under Local Anesthesia (Tula) System, the first device that allows ear tubes to treat recurrent ear infections in children, to be installed in a physician’s office under local anesthesia.

The approval came via the Breakthrough Devices pathway, which allows certain innovative devices to get expedited FDA review. The pathway...

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