Neptune Medical has received clearance from the US Food and Drug Administration (FDA) for its Triton 1 System, a robotic platform designed for flexible endoscopy and diagnostic and therapeutic procedures throughout the colon.

Colonoscopy is widely used for the detection, prevention and treatment of colorectal cancer because it allows doctors to identify and remove precancerous lesions during the same procedure. However, conventional endoscopes can be difficult to control, which may affect stability and visualisation during procedures and create physical strain for clinicians.

The Triton 1 System is designed to provide greater robotic precision, stability and control throughout the colon. The system is intended to support screening, surveillance and diagnostic colonoscopies, as well as more complex procedures such as endoscopic mucosal resections (EMRs) and endoscopic submucosal dissections (ESDs).

The system is designed to support consistent access and visualisation across the colon while reducing the physical demands associated with manual endoscopy.

The FDA clearance follows findings from Neptune Medical’s first-in-human CARE 1 clinical study, which was presented at Digestive Disease Week 2026. The study reported that the Triton 1 System met its primary endpoints, with no adverse events and a 100% caecal intubation rate.

The system also recorded an adenoma detection rate (ADR) of 54.2% in the study, compared with an industry threshold of 35%. The study reported a 67% reduction in average procedural burden for endoscopists compared with manual colonoscopy, based on the NASA Task Load Index (NASA-TLX).

The study also reported no need for patient repositioning, abdominal pressure or conversion to manual colonoscopy. Neptune Medical plans to use the clinical findings and feedback from endoscopists to further develop its robotic endoscopy technology and assess how robotics can be integrated into clinical workflows.

 

Source: businesswire.com

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