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QUOTED. 28 November 2019. Jeff Shuren.

Executive Summary

Tusker Medical won US FDA approval for its Tubes Under Local Anesthesia (Tula) System, the first device allowing ear tubes to treat recurrent ear infections in children to be installed in the physician's office under local anesthesia. See what Jeff Shuren, director of the agency's device center, said about it here.

“As millions of children suffer from ear infections every year, it is important to have safe and effective treatments available to this susceptible patient population.” – Jeff Shuren, director, US FDA Center for Devices and Regulatory Health (CDRH)

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