FDA approves C20 Invendoscope (Invendo Medical)

The FDA has provided 501(K) approval for the new C20 Invendoscope colonoscopy system including the SC20 single-use colonoscope, from Invendo Medical. This device is not pushed or pulled, but uses a computer-assisted gentle drive technology to move through the colon. This reduces forces on the colon wall. The C20 is a fully integrated unit with positioning arm attached to a base unit which contains power supply and control software. The SC20 is a more flexible system and is attached to the C20. A clinical trial produced 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.