EndoQuest Earns FDA Approval for Last Stage of PARADIGM Trial

EndoQuest Robotics, a company focused on endoluminal robotic surgical technology, announced U.S. Food and Drug Administration (FDA) approval for the next and final stage of its PARADIGM pivotal trial.

The PARADIGM trial (Prospective Assessment of a Robotic Assisted Device in Gastrointestinal Medicine) is an investigational device exemption (IDE) study that’s evaluating EndoQuest’s Endoluminal Surgical (ELS) system for use in endoscopic submucosal dissection (ESD). The FDA’s decision follows submission of a report about the ELS system’s safety results for the first set of subjects.

The approval permits completion of enrollment in advance of EndoQuest’s planned de novo classification request for authorization to market the ELS system in the U.S.

The first procedures were completed by pioneers in endoluminal surgery. This includes gastroenterologist Dr. Norio Fukami (Mayo Clinic Arizona), who became the world’s first gastroenterologist to perform a fully robotic ESD procedure as part of an IDE trial, and colorectal surgeons Dr. Matthew Albert (AdventHealth Orlando) and Dr. Eric Haas (HCA Houston Healthcare).

Dr. Haas said that using the ELS system, he could complete dissections and closures with surgical precision in anatomy that’s usually challenging or impossible to address using standard transanal techniques.

“The platform feels like a natural extension of my robotics skillset as a colorectal surgeon, and I look forward to continuing this trial as we explore how it may expand what’s possible in minimally invasive colorectal procedures,” Dr. Haas told the press.

The PARADIGM trial will assess the ELS system in robotic ESD procedures to remove lesions in the rectum and sigmoid colon. The study 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).

“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,” said EndoQuest CEO Eduardo Fonesca. “This milestone brings us closer to delivering meaningful value for patients, physicians, and healthcare systems.”

Last month, the company revealed it was integrating NVIDIA IGX Thor, a NVIDIA Blackwell-powered, enterprise-ready platform to help advance its next-generation robotic system toward commercialization. The collaboration will focus on integrating EndoQuest’s visualization system, robotic control, and secure cloud services using NVIDIA accelerated computing and software stack, including NVIDIA Holoscan, NVIDIA CUDA, and NVIDIA AI Enterprise.