September 17, 2026
1 min read
Key takeaways:
- The Triton 1 System received FDA clearance for use in diagnostic and therapeutic procedures throughout the colon.
- Results from the CARE 1 study showed no adverse events and 100% cecal intubation with the system.
A gastrointestinal robotic endoscopy system has received FDA 510(k) clearance for use in diagnostic and therapeutic procedures throughout the colon.
The Triton 1 System (Neptune Medical) was designed to improve endoscopic precision, stability and control and “elevate any endoscopist’s capabilities for screening, surveillance and diagnostic colonoscopies,” according to a manufacturer press release.
A gastrointestinal robotic endoscopy system has received FDA 510(k) clearance for use in diagnostic and therapeutic procedures throughout the colon.
The system also can be used for other procedures in the colon, including mucosal resections and submucosal dissections.
“Bringing robotics to lower GI procedures is an exciting prospect for us,” Jason B. Samarasena, MD, chief of the division of gastroenterology and hepatology at University of California, Irvine, said in the release. “Triton showed us the possibility of one system that can screen and treat anywhere in the colon, efficiently, thoroughly and with minimal burden.”
Neptune Medical earlier this year presented data from the first-in-human CARE 1 trial, which met both primary endpoints: no adverse events and 100% cecal intubation.
The system also had an adenoma detection rate of 54.2% — exceeding the 35% industry threshold — and demonstrated a 67% lower average ergonomic burden compared with manual colonoscopy, according to the release.
Patient repositioning, abdominal pressure or conversion to manual colonoscopy also were not required with use of the Triton 1 System in the trial.
“Triton has the potential to fundamentally transform colonoscopy, creating a better experience for both physicians and their patients,” Alex Tilson, founder and CEO of Neptune Medical, said in the release. “Achieving regulatory clearance in the U.S. brings us one step closer to that reality.”
Ask a clinical question and tap into Healio AI’s knowledge base.
- PubMed, enrolling/recruiting trials, guidelines
- Clinical Guidance, Healio CME, FDA news
- Healio’s exclusive daily news coverage of clinical data
