invendo medical GmbH Receives FDA Clearance Computer-Assisted Single-Use Colonoscopy System
Published: Mar 11, 2013
This initial entry of the US 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," said John J. Cifarelli, EVP Global Markets of invendo medical. "We are enthusiastic about the potential of our colonoscopy system and are confident that many US patients will appreciate the benefits of the invendo system when they have to decide which screening method would suit them best."
About invendo medical - www.invendo-medical.com
Based in New York, U.S.A. and Kissing (near Munich), Germany, invendo medical is a leading developer of disposable endoscopy products in the field of gastroenterology that are hygienically safe and employ "no manual push" computer-assisted, gentle advancement technology.
SOURCE invendo medical