Gastro Concepts has received US Food and Drug Administration (FDA) 510(k) clearance for its Air Assist device, advancing colonoscopy procedures.
The disposable Air Assist device is designed to prevent air and CO₂ escape during colonoscopy. It helps in manual control of air leakage and maintains colonic distension for better visibility and more efficient procedures.
Developed by a practising gastroenterologist with endoscopic experience, the Air Assist device solves a common challenge in colonoscopy.
This simple, safe solution enhances the colonoscopy experience for both endoscopists and support staff.
Made from self-lubricating medical-grade silicone, the Air Assist is easy to use and manoeuvre.
It creates a reversible seal between the colonoscope and the anus or stoma, enabling on-demand colonic distension. Both the endoscopist and technician can control the distension, improving procedure efficiency, visibility and patient outcomes.
Gastro Concepts chief medical officer Jason Slate said: “We are thrilled to bring this innovative device to the market.
“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 colonoscopy device is a single-use device, ensuring both safety and convenience.
It aims to set a new standard in colonoscopy by reducing frustration and boosting efficiency.
With this FDA clearance, Gastro Concepts continues its mission to enhance gastroenterology practices and improve patient care.
In a similar development, Odin Medical, an Olympus company, secured FDA 510(k) clearance for its cloud-based artificial intelligence (AI) endoscopy system for colonoscopy in September this year.
The CADDIE computer-aided detection (CADe) device is designed to assist gastroenterologists in detecting suspected colorectal polyps during colonoscopy procedures.
In July this year, Taiwan-based AAEON partnered with Insign Medical Technology to develop an AI-powered colonoscopy solution, dubbed EndoDASS.
