Invendo Medical, a company with offices in Garden City, NY and Kissing, Germany, received FDA 510(k) clearance to make available its innovative colonoscope in the U.S.
Unlike traditional endoscopic devices, the C20 colonoscopy system utilizes a motorized mechanism to move the scope along its route in a controlled manner.
From the announcement:
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 gentle drive technology
• all endoscopic functions are performed using a handheld device and
• it reduces forces on the colon wall
A clinical trial with the company’s colonoscope delivered convincing results with a >98% cecal intubation rate and lesions detected in 41% of screening subjects. No device-related adverse events were observed during the study.
The C20™ colonoscopy system has already received CE mark in Europe.
Press release: invendo medical announces 510(k) clearance by FDA for advancement-assisted single-use colonoscopy system…
Product page: The invendoscopy C20 system…