Neptune Medical Earns FDA Clearance for Triton 1 Robotic Endoscopy System

Neptune Medical Inc. has announced FDA clearance for its Triton 1 System, a robotic platform designed for flexible endoscopy across diagnostic and therapeutic procedures throughout the entire colon. The Burlingame, California-based company engineered the system to deliver robotic precision, stability, and control.

According to Neptune Medical, Triton elevates an endoscopist's capabilities for screening, surveillance, and diagnostic colonoscopies, as well as complex procedures like endoscopic mucosal resections and endoscopic submucosal dissections.

Alex Tilson, founder and CEO of Neptune Medical, stated:

"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."

Colorectal cancer remains the second leading cause of cancer death in the United States. While colonoscopy is the gold standard for diagnosis and prevention, traditional endoscopes present stability challenges that can lead to incomplete visualization and missed adenomas.

The clearance follows Neptune Medical's first-in-human CARE 1 clinical study. Results demonstrated 100% cecal intubation with zero adverse events, a 54.2% adenoma detection rate versus the 35% industry baseline, and a 67% reduction in ergonomic burden based on NASA-TLX scores.

Jason B. Samarasena, M.D., Chief of Gastroenterology at UC Irvine, stated:

"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."

The company previously raised $97 million in Series D funding and launched subsidiary Jupiter Endovascular.