FDA News

FDA approves Aer-O-Scope colonoscope system

The FDA has granted 510(k) clearance for the Aer-O-Scope colonoscope system from GI-View, the manufacturer has announced.

“Aer-O-Scope provides reliable and safe colorectal cancer screening. It also has the potential to increase the adenoma detection rate and concurrently help to prevent cancer," Erwin Santo MD, head of the department of gastroenterology and liver diseases at Tel Aviv Sourasky Medical Center and principal investigator of the most recent Aer-O-Scope clinical trial, said in the press release.

The Aer-O-Scope features a soft, multi-lumen tube designed to reduce pressure on the colon wall to increase safety, and self-propelled intubation using balloons and low pressure carbon dioxide gas to increase safety and ease of use, according to the release. The system is controlled by a joystick for simple operation and minimal training requirement, and the single use, disposable system has “no risk” for disease transmission, the company stated.

“Aer-O-Scope is the only colorectal screening product that is single use, self-propelled and has 360 degree omni-directional visualization,” Tal Simchony, PhD, CEO, of GI-View said in a press release. “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.”

Aer-O-Scope also provides standard insufflation, irrigation and suction, and market introduction is expected to begin in early 2016 in the United States, the release said.

The FDA has granted 510(k) clearance for the Aer-O-Scope colonoscope system from GI-View, the manufacturer has announced.

“Aer-O-Scope provides reliable and safe colorectal cancer screening. It also has the potential to increase the adenoma detection rate and concurrently help to prevent cancer," Erwin Santo MD, head of the department of gastroenterology and liver diseases at Tel Aviv Sourasky Medical Center and principal investigator of the most recent Aer-O-Scope clinical trial, said in the press release.

The Aer-O-Scope features a soft, multi-lumen tube designed to reduce pressure on the colon wall to increase safety, and self-propelled intubation using balloons and low pressure carbon dioxide gas to increase safety and ease of use, according to the release. The system is controlled by a joystick for simple operation and minimal training requirement, and the single use, disposable system has “no risk” for disease transmission, the company stated.

“Aer-O-Scope is the only colorectal screening product that is single use, self-propelled and has 360 degree omni-directional visualization,” Tal Simchony, PhD, CEO, of GI-View said in a press release. “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.”

Aer-O-Scope also provides standard insufflation, irrigation and suction, and market introduction is expected to begin in early 2016 in the United States, the release said.