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 throughout the colon.
The system is indicated for a range of diagnostic and therapeutic procedures and aims to address challenges associated with existing endoscope technology, particularly instability that can result in incomplete visualisation and missed lesions.
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It is designed to improve precision, stability and control during screening, surveillance and diagnostic colonoscopies, as well as complex interventions such as endoscopic mucosal resections and endoscopic submucosal dissections.
In the CARE I first-in-human clinical study presented earlier this year at Digestive Disease Week, Triton 1 met its primary endpoints, with no adverse events and a 100% cecal intubation rate.
The system also demonstrated an adenoma detection rate of 54.2% against an industry benchmark of 35% and was shown to reduce the average physical burden on endoscopists by 67%, as measured by NASA-TLX scoring.
No patient repositioning, abdominal pressure, or conversion to manual colonoscopy took place during the procedures.
Neptune Medical Founder and CEO Alex Tilson said: “Triton has the potential to fundamentally transform colonoscopy, creating a better experience for both physicians and their patients. Achieving regulatory clearance in the US 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.”
Neptune Medical is headquartered in Silicon Valley and develops endoscopy devices utilising its Dynamic Rigidization platform to improve minimally invasive patient care.
