Neptune Medical gains FDA clearance for robotic Triton 1

Neptune Medical has secured FDA clearance for its Triton 1 System, a robotic platform developed for flexible endoscopic procedures across the colon.

The system is designed to provide endoscopists with improved control, stability and precision during colonoscopy. 

It can be used for diagnostic and therapeutic procedures, including routine screening and surveillance as well as more complex interventions such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

Triton 1 is intended to address some of the handling and stability challenges associated with conventional endoscopes. 

Its robotic approach is designed to support navigation and visualisation throughout the colon while reducing the physical workload for clinicians.

The FDA clearance follows data from Neptune Medical’s CARE 1 first-in-human clinical study, which was presented at Digestive Disease Week 2026. 

The study achieved 100% caecal intubation, with no adverse events reported. The system recorded an adenoma detection rate of 54.2%, compared with an industry benchmark of 35%.

Clinical data also indicated a 67% reduction in average procedural workload for endoscopists compared with manual colonoscopy, based on NASA-TLX assessments. 

The procedures required no patient repositioning, abdominal pressure or conversion to manual colonoscopy.

Neptune Medical plans to continue clinical research to further develop its robotic endoscopy platform.