Neptune Medical’s Triton 1 Wins FDA Nod for Robotic Colonoscopy

Neptune Medical has received U.S. Food and Drug Administration (FDA) clearance for Triton 1, a robotic system built for flexible endoscopy in diagnostic and therapeutic procedures throughout the colon.

Today’s endoscopes can be difficult to control, even for highly trained gastroenterologists. Instability can limit visualization, contribute to missed adenomas, and increase clinician strain.

The Triton 1 system is a robotic GI endoscopy platform designed to provide precision, stability, and control throughout the colon. It’s intended for screening, surveillance, and diagnostic colonoscopies, as well as advanced procedures such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The first-in-human CARE 1 study, presented at DDW 2026, met its primary endpoints with no adverse events and 100% cecal intubation. Triton 1 achieved a 54.2% adenoma detection rate versus the 35% industry threshold and reduced endoscopist workload by 67% compared with manual colonoscopy, with no patient repositioning, abdominal pressure, or conversion to manual procedures.

Comments from Neptune Medical and clinicians

Alex Tilson, founder and CEO: “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. We are using this generation of the Triton system to build on the evidence from our recent trial and to learn from endoscopists how robotics should integrate into their workflow—insights that will directly shape our next-generation platform.”

Jason B. Samarasena, MD, chief of division of gastroenterology and hepatology, University of California: “Bringing robotics to lower GI procedures is an exciting prospect for us. Triton showed us the possibility of one system that can screen and treat anywhere in the colon, efficiently, thoroughly, and with minimal burden. I look forward to participating in additional clinical research of the system that will support its progress along the path to commercialization.”