Installations Follow Special 510(k) Clearance by FDA for Computer-Assisted Single-Use Colonoscopy System
Invendo medical officials announce that the company entered the U.S. market by installing first systems at NYU Langone Medical Center and NewYork-Presbyterian Hospital/Columbia University Medical Center. First U.S. patients have already undergone a colonoscopy with the new C20 colonoscopy system including the SC20 single-use colonoscope.
This initial entry of the U.S. market follows a special 510(k) clearance by the FDA, which cleared several important product improvements for marketing.
The invendoscope SC20 has several features that are new to the field of colonoscopy:
- It is a single-use colonoscope with a working channel
- It is not pushed or pulled, but uses a computer-assisted (robotic) gentle drive technology
- All endoscopic functions are performed using a handheld device and
- It reduces forces on the colon wall
"We are proud that two such highly regarded clinical institutions have decided to offer their patients an additional option for colonoscopy," says John J. Cifarelli, EVP Global Markets, invendo medical. "We are enthusiastic about the potential of our colonoscopy system and are confident that many U.S. patients will appreciate the benefits of the invendo system when they have to decide which screening method would suit them best."