EvoEndo Announces US FDA 510(k) Clearance for Single-Use Unsedated Transnasal Endoscopy (TNE) System
- EvoEndo’s Single-Use Endoscopy System or the “EvoEndo System” eliminates the need for general anesthesia or conscious sedation during routine upper endoscopic procedures
- The EvoEndo System is being distributed by Micro-Tech Endoscopy USA with commercial sales slated to begin following completion of first clinical cases at several pediatric facilities
EvoEndo®, Inc. (“EvoEndo”), a medical device company developing systems for Unsedated Transnasal Endoscopy (TNE), has announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) to begin marketing and sale of the EvoEndo® Single-Use Endoscopy System. The clearance follows EvoEndo’s distribution agreement with Micro-Tech Endoscopy USA, Inc. (“Micro-Tech”), which will begin a phased distribution of the EvoEndo System into hospitals and ASCs in the United States.
EvoEndo was founded in 2017 by Dr. Joel Friedlander, a Pediatric Gastroenterologist at Children’s Hospital of Colorado, and is led by Chief Executive Officer Dr. Heather Underwood, an experienced medical device and technology entrepreneur, and alumna of the Stanford University Biodesign Program. While traditional endoscopy requires patients to undergo general anesthesia or sedation, the EvoEndo System combines sterile, single-use, flexible endoscopes, a portable video controller, and a take-home “comfort kit” containing virtual reality (VR) goggles for patient entertainment and distraction during the procedure to allow for unsedated transnasal endoscopy. The EvoEndo System ultimately enables safer and more cost-effective upper endoscopic procedures for patients, doctors, and hospitals. The FDA clearance is the latest milestone for EvoEndo, who also announced the completion of a $10.1M equity financing round last June.
Heather Underwood, Chief Executive Officer at EvoEndo, commented, “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.”
“With today’s announcement, we are one step closer towards making unsedated endoscopies the standard of care within the medical community,” said Joel Friedlander, Chief Medical Officer and Co-Founder of EvoEndo. “We are thrilled to receive this clearance and proud to be on the forefront of a new and innovative system to help diagnose and treat pediatric and adult patients.”
“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,” stated Micro-Tech USA President Chris Li. “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.”