A developer of endoscopy products based in New York and Kissing, Germany, invendo medical, announced that the company received 510(k) clearance by the FDA of the company’s new C20 colonoscopy system, including the SC20 single-use colonoscope.
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 demonstrated a > 98% cecal intubation rate, and lesions were detected in 41% of screening subjects. No device-related adverse events were observed during the study.
The C20 colonoscopy system had already received CE mark in Europe. Clearance by FDA makes the new endoscope available for colon cancer screening in the United States. ■