EvoEndo announced today that it received expanded FDA clearance for its Model LE gastroscope, covering patients of all ages.
Denver-based EvoEndo’s offering now covers neonates to adults, expanding the previous indication for patients aged five and older.
The company says its system has been the only option available for sedation-free transnasal endoscopy for pediatric patients above five since 2022. Now, FDA clearance makes safe, transoral endoscopy available to infants and young children.
EvoEndo says the new indication establishes it as “the leading choice for all endoscopies.” The company now offers endoscopy ranging from sedated transoral procedures in babies to sedation-free transnasal cases in adults. Its ChannelMax technology accommodates most standard pediatric accessories, according to a news release. The system has scopes available in both 85 and 110 cm lengths. This makes them suitable for small or challenging anatomy in a broad range of indications.
The company designed its system as a lightweight, portable option that users can easily scale to multiple settings for care at the site of service. This makes diagnostic and therapeutic endsocopy more accessible, timely and convenient.
“EvoEndo was the first to achieve FDA clearance for an ultra-slim endoscope for pediatric patients, age five and older. We continue to innovate and are pleased to announce that we have expanded our indication to include all patients. The EvoEndo endoscopy system is now FDA-cleared for use with no age restrictions, elevating care for newborns and infants who will benefit from our ultra-slim technology,” said EvoEndo CEO Jonathan Hartmann.
