Colibri micro ENT scope is claimed to be the world's first single-use endoscope specifically developed for otology
The US FDA’s Center for Devices and Radiological Health. (Credit: The U.S. Food and Drug Administration)
Israeli medical device technology 3NT Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Colibri endoscopy system.
Colibri micro ENT scope is claimed to be the world’s first single-use endoscope specifically designed for otology.
The new endoscopy system integrates a lightweight ergonomic handpiece and 2.2mm diameter tip, as well as built-in suction to facilitate two-handed functionality in a single device.
3NT’s sterile endoscope has been developed to improve the safety of both patients and medical staff by reducing the risk of cross-contamination, which is a major issue when reprocessing multi-use devices.
According to the company, one in seven Americans reports some degree of hearing loss, with over four million office visits annually associated with chronic ear disease.
Colibri enables to apply a minimally invasive and endoscopic transcanal approach, and offers a better wide-angle view of hidden middle ear structures.
Colibri endoscope is also suitable for use in an endoscope-assisted microscopic approach
In addition, the company has designed the Colibri endoscope for use in an endoscope-assisted microscopic approach.
3NT Medical CEO Ehud Bendory said: “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.”
In May 2018, 3NT Medical announced the initial closing of a major part of its $15m financing round from Hoya. The financing round was led by Hoya and it is its first venture investment in an Israeli company.
3NT Medical is engaged in the development of advanced endoscopic solutions for otorhinolaryngology applications across the world.