EvoEndo’s Single-Use Endoscopy System can be used without anaesthesia. Image credit: EvoEndo.

University medical centre Duke Health has become the first healthcare facility in North Carolina, US, to offer EvoEndo’s sedation-free, transnasal endoscopy (TNE) gastroscope to paediatric patients.

EvoEndo’s Single-Use Endoscopy System is for TNE of the upper gastrointestinal (GI) tract in patients aged five years and above.

The device gained 510(k) clearance from the US Food and Drug Administration (FDA) in 2022. With a slimmer form factor than traditional endoscopy systems, it is said to be the only FDA-cleared device designed specifically for use in paediatric patients.

The system comprises a single-use, flexible scope with integrated air, water, and suction ability, and features four-way steering functionality and a portable controller with a video screen.

In addition, the device comes bundled with single-use virtual reality (VR) goggles with in-built age-appropriate content for patient distraction.

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EvoEndo’s system is gradually being rolled out to healthcare sites across the US, with the rollout at Duke Health following a launch in a Texas paediatric hospital in April 2024.

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Last year, the device rolled out at University Hospitals (UH) Rainbow Babies & Children’s Hospital in north-east Ohio.

Paediatric gastroenterologist at Children’s Hospital of Philadelphia (CHOP), Dr Matthew Ryan, recently announced the completion of over 100 TNEs using EvoEndo’s device.

EvoEndo was co-founded in 2017 by paediatric gastroenterologist Dr Joel Friedlander and other doctors at the Children’s Hospital of Colorado.

In 2021, the company secured $10.1m in equity financing for the development of its TNE system.

According to GlobalData analysis, the US gastroscope market was valued at around $388m in 2023. Growing at a CAGR of 3.8%, it is forecast to reach a valuation of around $581m by 2033, as per GlobalData’s Market Size & Growth database.