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Cutting-Edge Endoscopy Device Receives FDA Breakthrough Device Designation, Paving Way for Improved GI Tract Diagnosis and Treatment

Supriyo Rana & Claudia Shi | March 24, 2023

Founded in 2018 by Vanderbilt professor Dr. Robert J. Webster and Dr. Joshua Gafford, EndoTheia is a Nashville-based medical device company which recently received a Breakthrough Device Designation from the Food and Drug Administration (FDA), due to its flexible therapeutic endoscopic technology. Endoscopic surgery is a minimally invasive surgical method which uses a thin tube to visualize conditions and operate within a human body. As a company, EndoTheia aims to revolutionize the world of minimally invasive flexible endoscopic surgery. Their mission is to “develop the next generation of medical devices for flexible endoscopy with the goal of increasing effectiveness through added flexibility and dexterity.”

The design 

EndoThea’s devices provide advanced steerability to endoscope-delivered tools, opening the door for new diagnostic and therapeutic applications of flexible endoscopy. Specifically, EndoTheia’s design contains extremely thin-walled, laser-machined metallic tubes which enable the creation of highly flexible, steerable devices. These devices can pass through standard endoscopes while also internally carrying interventional tools. Due to their steerability, EndoTheia’s technology can be used in numerous clinical specialties, including urology (study of the urinary and reproductive system), gastroenterology (study of the digestive system), neurology (study of brain), otology (anatomical study of ear), and ear, nose and throat (ENT). 

Because the EndoTheia systems are adaptable and directly compatible with current standard clinical endoscopes, they can be easily applied to a wide range of surgical interventions without rebuilding the entire endoscope. 

For example, the directional movement of standard baskets that remove kidney stones are limited to straight-line extension, which makes detection and removal of small stone pieces cumbersome and extremely difficult. EndoTheia provides a retrieval system, FlexStone, which solves this problem with the use of a basket that can carry small stones within a miniature-sized sheath with ultra-thin walls.  The company is also planning to realize ureteroscopic laser lithotripsy, which is the fragmentation of urinary stones with laser fibers, with FlexStone, because the sheaths within the technology are potentially tiny enough for laser fibers to perform more precise work.

On the other hand, EndoThea also provides a system designed for endoscopic submucosal dissection (ESD) with 2 maneuverable tips – a gripping arm and a cutting arm – that are independently controlled to enhance internal visualization and endoscopic motion. During procedures, the gripping arm grabs onto cancerous tissues, while the cutting arm removes them from surrounding tissue.

Working together and future steps

Dr. Gafford, current CTO of EndoTheia, explains how the company enhanced their design by incorporating engineering, clinical, and robotics principles: “We believe that the only way to make a great medical device is through combined effort, with engineers and clinicians working hand-in-hand toward the greater good.” This interdisciplinary development of design ensures that physicians are fully participating during the research process to provide valuable feedback for technical improvements.

On January 10, 2023, EndoTheia’s technology received the Breakthrough Device designation from the FDA, which enabled the company to bring its solution to its market of doctors and patients. 

Such designations are granted by the FDA to novel medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. EndoTheia’s device is only the seventh ENT device to receive the FDA Breakthrough Device designation. By receiving the coveted Breakthrough Device designation, EndoTheia is one step closer to bringing their endoscopic device to hospitals around the country.

If you would like to learn more about EndoTheia, visit If you would like to learn more about the Breakthrough Device designation, please visit


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