FDA OKs 3NT Medical’s Colibri Micro ENT Scope

3NT Medical, a privately-held corporation dedicated to developing single-use specialized endoscopes for the diagnosis and treatment of ear, nose, and throat (ENT) disorders, announced FDA 510(k) clearance for the Colibri Micro ENT Scope, the world’s first single-use endoscope specifically designed for Otology. The Colibri endoscopy system incorporates a lightweight ergonomic handpiece, a 2.2mm diameter tip, and built-in suction to enable two-handed functionality in a single device. Furthermore, this sterile endoscope enhances safety for both patients and medical staff by eliminating the risk for cross contamination, which is a concern when reprocessing multi-use devices.
 
“Colibri enables me to use both hands to perform surgery, returning to the familiar otologic position, and at the same time provides the benefits of endoscopic visualization and illumination,” said Dr. Daniel I. Choo, Director, Division of Pediatric Otolaryngology at Cincinnati Children’s Hospital. “I look forward to using Colibri in my surgical practice.”
 
1 in 7 Americans report some degree of hearing loss, with more than 4 million office visits annually attributed to chronic ear disease. Ear surgery is successful in addressing the disease burden and stabilizing or improving hearing, but traditional microscopic approaches may require large skin incisions and time-consuming bone drilling. Colibri allows for a minimally invasive, endoscopic transcanal approach, and provides an excellent, wide angle view of hidden middle ear structures. Colibri endoscope can also be used in an endoscope-assisted microscopic approach.
 
“We are excited to make this new, single-use endoscope available for select surgeons in the U.S.,” said Ehud Bendory, CEO of 3NT Medical. “This is a critical first step toward our strategic objective of commercializing a full portfolio of single-use endoscopes designed with the specific needs of otolaryngologists in mind. We expect our family of products will enable surgeons to improve clinical outcomes and patients’ quality of life, while eliminating cross infection risk associated with using and cleaning multi-use devices.”