3NT Medical lands FDA clearance for Colibri endoscopy system

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 …

Read more
  • 0