Gastro Concepts Receives FDA Clearance for Air Assist™ Device, Revolutionizing Colonoscopy Procedures

ALBUQUERQUE, N.M., Dec. 16, 2024 /PRNewswire/ -- Gastro Concepts, a team committed to advancing safety and efficiency in gastroenterology, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking Air Assist™ device.

The Air Assist is a novel, disposable device designed to prevent air and CO escape during colonoscopy, thereby maintaining colonic distension for enhanced visibility and more efficient procedures.

Developed by a practicing gastroenterologist with extensive endoscopic experience, the Air Assist addresses a common issue encountered during colonoscopy. This simple, safe solution promises to improve the colonoscopy experience for both endoscopists and support staff. The device, made of self-lubricating medical-grade silicone, is easy to use and maneuver. It forms a reversible seal between the colonoscope and the anus or stoma, allowing for on-demand colonic distension that can be controlled by either the endoscopist or the technician.

“We are thrilled to bring this innovative device to the market,” said Dr. Jason Slate, Chief Medical Officer of Gastro Concepts. “The Air Assist will not only simplify the procedure but also enhance patient outcomes by providing superior visibility during both diagnostic and therapeutic colonoscopy.”

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