EndoQuest Robotics has received FDA clearance to move into the final stage of enrollment for its pivotal PARADIGM Trial — a milestone that quietly signals growing confidence in robotic-assisted endoscopic surgery.
The decision follows a favorable interim safety review of the company’s investigational Endoluminal Surgical (ELS) System, designed to bring surgical-grade precision into procedures traditionally constrained by the limits of flexible endoscopy. Notably, early cases have already pushed historical boundaries, including what’s believed to be the first fully robotic ESD performed by a gastroenterologist within an IDE trial.
What’s at stake here isn’t just another device approval. If successful, PARADIGM could help define an entirely new category of minimally invasive GI intervention — one that blurs the line between surgery and endoscopy, and reshapes who can do what inside the endoscopic suite.
With enrollment now expanding across multiple leading U.S. centers, the next phase may determine whether endoluminal robotics remains a niche innovation — or becomes a new standard for complex GI resections.