EvoEndo’s Gastroscope Earns FDA Clearance for All Ages

The U.S. Food and Drug Administration (FDA) has cleared EvoEndo Inc.’s EvoEndo Model LE Gastroscope for patients of all ages (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. The expanded indication now makes safe, transoral endoscopy available to infants and young children, a previously underserved population.

“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,” EvoEndo CEO Jonathan Hartmann stated. “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 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 more than 40 facilities nationwide, with additional locations coming soon.

“This expanded clearance is a major step forward,” pediatric gastroenterologist Dr. Michael Manfredi stated. “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.”

EvoEndo Co-Founder/ Chief Medical Officer Dr. Joel Friedlander noted 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 numerous indications.

The EvoEndo Model LE Gastroscope helps clinicians visualize the upper digestive tract in adults and pediatric patients. The device allows physicians to observe, diagnose, and endoscopically treat 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.