Israel-based GI View has received 510(k) approval from the US Food and Drug Administration (FDA) for its Aer-O-Scope Colonoscope System, an advanced and easy-to-use system for colorectal cancer screening.
Aer-O-Scope has 360° omni-directional visualization, and is designed to reduce pressure on the colon wall, which in turn, increases patient safety.
Created using balloons and low pressure CO2 gas, the system’s self-propelled intubation maximizes the safety and ease of use, according to the company.
The system is simple to operate, as it is joystick controlled, and because of single use there will be no risk of disease transmission from it. It also provides insufflation, irrigation and suction, similar to other colonoscopies.
GI-View CEO Dr Tal Simchony said: "Aer-O-Scope is the only colorectal screening product that is single use, self-propelled and has 360° omni-directional visualization.
"This enables the physician to observe all the mucosa of the colon, including behind folds, which is critical for a complete colonic assessment. If a polyp is there, Aer-O-Scope will allow the physician the best possible chance of finding it."
The company intends to launch the system in the US in early 2016.