Ear-Tube Insertion Moves To Physician Offices With Breakthrough Device
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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Hyman, Phelps & McNamara partner Allyson Mullen has helped many manufacturers get breakthrough device designations from the US FDA. In this conversation, she shares her insights on the process, the best way to prepare, and why some designated devices might be slow to make it to shelves.