EvoEndo today said it received FDA 510(k) clearance for its single-use endoscopy system.
Denver-based EvoEndo designed the single-use endoscopy system with a sterile, single-use, flexible endoscope and a portable video controller and take-home “comfort kit” with virtual reality goggles for patient entertainment and distraction during a transnasal endoscopic procedure. EvoEndo’s scope has a 3.5 mm outer diameter that is small enough for most noses and does not require anesthesia or sedation during diagnostic upper endoscopy, according to the company. It is 1.1 m in length and allows for evaluation and treatment in a full pediatric trans nasal upper GI exam. Its 2 mm working channel accommodates standard and affordable pediatric biopsy forceps and has four-way steering to examine the esophagus, stomach and small intestine in a 120º field of view.
“Receiving FDA 510(k) clearance for the EvoEndo System will allow us to execute on our mission of enabling a safer, faster, and more affordable alternative to sedated endoscopy for both pediatric and adult patients. This is an exceptional accomplishment for our team and validates our ongoing commitment to transform best practices in endoscopy and support the broader adoption of unsedated procedures throughout the U.S.,” CEO Heather Underwood said in a news release.
The company plans to begin marketing and sale of the EvoEndo single-use endoscopy system following the FDA clearance and will be distributed through Micro-Tech Endoscopy into hospitals in the U.S.
“The EvoEndo Model LE single-use gastroscope addresses critical clinical needs in current pediatric and adult endoscopy practice and is a prime example of the innovative medical technology we strive to provide to our network,” Micro-Tech president Chris Li said. “A combination of the smaller scope size, larger biopsy channel, coupled with a sterile single-use device can help save valuable procedure time and cost. We look forward to further growing our partnership with EvoEndo and to the successful completion of initial clinical cases.”