The US Food and Drug Administration (FDA) has granted 510(k) approval for invendo medical's new C20 colonoscopy system.
The C20 system includes a single-use SC20 single-use colonoscope with a working channel.
The colonoscope utilizes computer-assisted gentle drive technology, while all endoscopic functions are performed using a handheld device.
The approval was based on a clinical trial which demonstrated that the company’s colonoscope delivered convincing results with a >98% cecal intubation rate and lesions detected in 41% of screening subjects.
invendo medical CEO Berthold Hackl said they believe that the invendo system reduces the burden associated with current conventional systems and that it may help to improve colonoscopy compliance rates, one of the key factors affecting the future incidence of colorectal cancer.