3NT Medical announced that it received FDA 510(k) clearance for its Colibri micro ENT single-use endoscope used for otology.
In a news release, the Short Hills, N.J.-based company touted the Colibri scope as the world’s first single-use endoscope specifically designed for otology. It features a lightweight, ergonomic handpiece, a 2.2mm diameter tip and a built-in suction to enable two-handed functionality in a single device.
The company said the sterile scope enhances safety for patients and medical staff by eliminating cross-contamination risks associated with reprocessing multi-use devices. Its endoscopic, transcanal approach offers a wide-angle view of hidden middle ear structures, the company said.
“We are excited to make this new, single-use endoscope available for select surgeons in the U.S.,” 3NT Medical CEO Ehud Bendory said in the release. “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.”