EvoEndo® Endoscopy System Receives FDA Clearance for All Ages

July 31, 2025 at 06:06 AM EDT

EvoEndo^®, Inc. (EvoEndo) announces that the EvoEndo® Model LE Gastroscope is now FDA-cleared for patients of all ages — from neonates to adults. Since 2022, the EvoEndo System has been the only option available for sedation-free transnasal endoscopy for pediatric patients five and older. Now, the expanded indication makes safe, transoral endoscopy available to infants and young children, a previously underserved population. In just three years, EvoEndo has redefined what’s possible – and who it’s possible for.

CEO Jonathan Hartmann remarked, “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.”

The new indication firmly establishes EvoEndo as the leading choice for all endoscopies, from sedated transoral procedures in babies to sedation-free transnasal procedures preferred by older pediatric and adult patients.

“This expanded clearance is a major step forward,” stated pediatric gastroenterologist Dr. Michael Manfredi. He added, “Being able to use the EvoEndo system in children under five allows us to safely support diagnosis and care in even the youngest patients. It also opens the door to broader applications beyond transnasal endoscopy, giving pediatric specialists more flexibility to deliver safer, more effective care for this vulnerable population.”

According to co-founder and CMO Dr. Joel Friedlander, the new indication “enables gastroenterologists and pediatric surgeons to provide care for patients across the entire age spectrum.” ChannelMax® technology accommodates most standard pediatric accessories, and with scopes available in both 85 and 110 cm lengths, they are suitable for small or challenging anatomy and a broad range of indications.

The EvoEndo System is lightweight, portable, and easily scalable to multiple settings, allowing for care at the site of service. This makes diagnostic and therapeutic endoscopy more accessible, timely, and convenient for both patients and physicians. EvoEndo remains committed to expanding access and elevating the standard of care for every patient and is already available in over 40 facilities nationwide, with additional locations coming soon.

Indications for Use

The EvoEndo Model LE Gastroscope is intended for the visualization of the upper digestive tract in adults and pediatric patients, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenal bulb. The gastroscope is a sterile, single-use device and can be inserted orally or transnasally. The EvoEndo Controller is intended for use with an EvoEndo Endoscope for endoscopic diagnosis, treatment, and video observation.

To learn more, please visit https://evoendo.com.