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January 17, 2023 | Tom Ballard

EndoTheia secures FDA designation as breakthrough device

The Nashville-based start-up's foundational technology was developed at Vanderbilt and UT, Knoxville.

A company co-founded by a Vanderbilt University faculty member and based on foundational technology that was originally invented at Vanderbilt and the University of Tennessee, Knoxville has gained priority status from the U.S. Food and Drug Administration by receiving a breakthrough device designation.

The announcement was made by EndoTheia Inc., a Nashville-based medical device company, for its technology that radically improves minimally invasive flexible endoscopic surgery. According to the company’s news release, it is only the seventh device in the category of Ear Nose and Throat to ever receive this designation. Vanderbilt noted in its news release that this type of designation is granted to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The designation will streamline the regulatory process, enabling EndoTheia to rapidly bring its innovative solution to doctors and patients. The company was founded in 2018 by Robert J. Webster III and S. Duke Herrell III.

The technology, based on extremely thin-walled, laser-machined metallic tubes, enables the creation of highly flexible, steerable devices that can pass through standard endoscopes, while also carrying within themselves interventional tools. The steerability that these devices provide to endoscope-delivered tools opens the door for new diagnostic and therapeutic applications of flexible endoscopy. EndoTheia’s disruptive platform technology can be used across a vast array of clinical specialties, including urology, gastroenterology, neurology, and otology.