PARADIGM, a pivotal multicenter study, evaluates the company’s Endoluminal Surgical (ELS) system. It looks at ELS in lower gastrointestinal (GI) tract procedures by both colorectal surgeons and gastroenterologists.
The FDA granted investigational device exemption (IDE) for the study in December 2024. In May 2025, the company announced the first colorectal cases in the trial. In October 2025, the company reported the completion of the world’s first fully robotic endoscopic submucosal dissection (ESD) performed by a gastroenterologist in an IDE trial.
Now, the FDA says the company may proceed with the last stage of the pivotal multicenter trial. The decision follows the submission of a report on the safety results for the ELS system for the first set of subjects. Approval enables the completion of enrollment in the study ahead of a planned de novo classification request in the U.S.
PARADIGM is enrolling 50 subjects across five leading U.S. healthcare institutions: HCA Healthcare (Houston), Mayo Clinic (Scottsdale), Cleveland Clinic (Cleveland), Brigham and Women’s Hospital (Boston) and AdventHealth (Orlando).
More about the EndoQuest robot and the PARADIGM trial
EndoQuest designed its surgical robot platform to address unmet needs in GI and other endoluminal surgeries. The system can deliver precision and flexibility to improve patient outcomes. The company says it enables endoluminal procedures with the visualization, precision and main tenets of conventional surgical techniques. It allows for surgical tasks and maneuvers not currently possible in advanced therapeutic endoscopy.
The proprietary technology navigates and performs procedures within the body’s lumina spaces, allowing for minimally invasive interventions. It makes it possible for therapeutic endoscopists and surgeons to operate through a trans-oral or trans-anal approach. EndoQuest raised $42 million to support the platform more than a year ago.
Pre-clinical data previously demonstrated a reduced learning curve and full-thickness defect closure with the EndoQuest system.
The company is also collaborating with Nvidia to integrate Nvidia’s IGX Thor platform into its next-generation surgical robotic system.
Commentary from EndoQuest leadership
John Magnasco, VP of Quality and Regulatory at EndoQuest Robotics, said:
“We continue to be pleased with our clear, timely and positive interactions with the FDA via their Safer Technologies Program (STeP). This approval reflects a collaborative approach that prioritizes patient safety and innovation. We look forward to working closely with the Agency as we move toward De Novo submission.”
Eduardo Fonseca, CEO of EndoQuest Robotics, said:
“With every case, we advance toward defining a new category of surgery and further build on our leading position to establish robotics in the endoscopic suite. This milestone brings us closer to delivering meaningful value for patients, physicians, and healthcare systems.”
Dr. Todd Wilson, chief medical officer and chair of the International Advisory Board of EndoQuest Robotics, said:
“We are highly encouraged by the positive results of the first stage of our trial and the dedication of our investigators. Our mission is to redefine what’s possible in minimally invasive procedures and enable the next shift in patient outcomes. This approval to complete enrollment in our pivotal trial is a testament to the progress we have made towards achieving that goal.”
