Neptune Medical has received U.S. Food and Drug Administration clearance for its Triton 1 System, a robotic endoscopy platform designed for diagnostic and therapeutic procedures throughout the colon.
The Triton 1 System is purpose-built for next-generation flexible endoscopy and is designed to provide robotic precision, stability and control throughout the colon. According to Neptune Medical, the technology is intended to support endoscopists performing screening, surveillance and diagnostic colonoscopies as well as more complex procedures, including endoscopic mucosal resections (EMRs) and endoscopic submucosal dissections (ESDs).
The FDA clearance comes as colorectal cancer remains the second-leading cause of cancer death in the U.S. and increasingly affects adults younger than 50. Colonoscopy allows clinicians to both detect and remove precancerous lesions during a single procedure.
Neptune Medical said conventional endoscopes have design limitations that can make them difficult to control despite gastroenterologists undergoing years of specialized training. Endoscope instability can contribute to incomplete visualization of the colon and missed adenomas. Manual endoscopy can also place significant physical stress on clinicians.
“Triton has the potential to fundamentally transform colonoscopy, creating a better experience for both physicians and their patients. Achieving regulatory clearance in the U.S. brings us one step closer to that reality,” said Alex Tilson, founder and CEO of Neptune Medical.
Tilson said the company is using this generation of the Triton system to build on evidence from its recent trial and learn how endoscopists believe robotics should integrate into their workflows. Those insights will help shape the company’s next-generation platform.
Clinical Study Examines Robotic Colonoscopy
The Triton 1 System was evaluated in Neptune Medical’s first-in-human CARE 1 study, which was presented at Digestive Disease Week 2026.
According to the company, the system met the study’s primary endpoints, with no adverse events and 100% cecal intubation. The robotic system demonstrated an adenoma detection rate of 54.2%, compared with an industry threshold of 35%.
The study also examined clinician ergonomics. Neptune Medical reported a 67% lower average burden compared with manual colonoscopy based on the NASA-TLX score. Procedures required no patient repositioning, abdominal pressure or conversion to manual colonoscopy.
“Bringing robotics to lower GI procedures is an exciting prospect for us,” said Jason B. Samarasena, M.D., chief of the Division of Gastroenterology and Hepatology at the University of California, Irvine, who participated in Neptune Medical’s CARE 1 clinical trial.
“Triton showed us the possibility of one system that can screen and treat anywhere in the colon, efficiently, thoroughly, and with minimal burden,” Samarasena added. “I look forward to participating in additional clinical research of the system that will support its progress along the path to commercialization.”
