FDA Clears Robotic System for Endoscopic Procedures in the Colon

The FDA has cleared the Triton 1 System, a robotic endoscopy system, for diagnostic and therapeutic procedures throughout the colon.¹ The 510(k) clearance covers use of the system for procedures including screening and surveillance colonoscopy, as well as more complex interventions such as endoscopic mucosal resection and endoscopic submucosal dissection.

Colonoscopy is used for colorectal cancer screening, surveillance, diagnosis, and removal of precancerous lesions. The Triton 1 System is designed to provide robotic control, stability, and maneuverability during flexible endoscopy throughout the colon. According to the developer Neptune Medical, the system is intended to address challenges associated with controlling conventional endoscopes and to support both diagnostic visualization and therapeutic procedures.

“Bringing robotics to lower [gastrointestinal] procedures is an exciting prospect for us,” Jason B. Samarasena, MD, chief of the Division of Gastroenterology and Hepatology at University of California, Irvine, stated in a news release.¹ “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.”

The FDA clearance expands the range of robotic technologies being evaluated for lower gastrointestinal endoscopy, with applications spanning colorectal cancer prevention and treatment. Because the clearance encompasses both screening and therapeutic procedures, the Triton 1 System can be used across different stages of colonoscopic care.

Supporting Data: CARE I Study

The clearance follows findings from the first-in-human CARE I study (NCT06935734) presented at Digestive Disease Week 2026. The 2-part study aimed to evaluate safety and efficacy of robotic colonoscopy in patients aged 22 years or older indicated for screening, surveillance, or diagnostic colonoscopy.²

Primary end points for the efficacy evaluation evaluated included successful completion of colonoscopy and major adverse events; secondary end points included need for repositioning, Adenoma Detection Rate (ADR), successful polypectomy, time to cecum, mucosal injury score graded from 1–5 (1, erythema/bruising; 5, full-thickness injury), and physical and mental load.

The trial met its primary end points, with no adverse events reported and a 100% cecal intubation rate. The system also demonstrated an ADR of 54.2%, compared with an industry threshold of 35%, and a polyp detection rate of 67.5%.

Ergonomic Experience

The CARE I study also evaluated the ergonomic experience of the endoscopist. Procedures performed with the Triton 1 System were associated with a 67% lower average procedural burden compared with manual colonoscopy based on the NASA Task Load Index (NASA-TLX), a tool used to assess perceived workload across multiple dimensions.

The finding suggests a potential reduction in procedural burden, as colonoscopy requires clinicians to manipulate and advance a flexible endoscope while maintaining visualization and control. Rather than relying on conventional manual manipulation, the robotic control offered by the Triton 1 System may reduce the physical and cognitive workload associated with colonoscopy procedures.

REFERENCES

1. Neptune Medical Receives FDA Clearance for Triton Robotic Endoscopy System. News release. Neptune Medical. September 16, 2026. Accessed September 17, 2026. https://tinyurl.com/2s3s7pkd

2. Romańczyk M, Romańczyk T, Samarasena JB. 979b Colonoscopy with a robotic endoscope (CARE) study: 50-patient first-in-human experience using a novel robotic colonoscopy system (Triton). Gastrointest Endosc. 2026;103(5 suppl):S-2853. doi:10.1016/S0016-5107(26)06679-4