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 CO₂ 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.”
The Air Assist™ is designed for single use, ensuring safety and convenience, and aims to set a new standard in colonoscopy procedures by reducing frustration and improving efficiency. Gastro Concepts is dedicated to developing solutions that elevate the practice of gastroenterology, and the FDA clearance of the Air Assist™ marks a significant milestone in that mission.
For more information on the Air Assist™ and Gastro Concepts, visit www.gastroconcepts.net or Email [email protected].
SOURCE Gastro Concepts
