Silicon Valley-based medical technology company Neptune Medical has received clearance from the US Food and Drug Administration (FDA) for its Triton 1 robotic platform, designed to enable flexible endoscopy throughout the colon.

The system is indicated for a range of diagnostic and therapeutic procedures and is designed to address limitations associated with conventional endoscope technology, particularly instability that can contribute to incomplete visualisation and potentially missed lesions.

Triton 1 is designed to provide greater precision, stability and control during screening, surveillance and diagnostic colonoscopies, as well as complex procedures including endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).

The US regulatory clearance follows results from the CARE I first-in-human clinical study, presented earlier this year at Digestive Disease Week. In the study, Triton 1 met its primary endpoints, with no adverse events reported and a 100% caecal intubation rate.

The platform also recorded an adenoma detection rate of 54.2%, compared with an industry benchmark of 35%. In addition, the study reported a 67% reduction in the average physical burden on endoscopists, measured using the NASA Task Load Index (NASA-TLX).

During the procedures, there was no need for patient repositioning, abdominal pressure or conversion to manual colonoscopy, according to the company.

Alex Tilson, Founder and CEO, Neptune Medical, said the regulatory clearance marked a step towards changing the way colonoscopy is performed.

“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,” Tilson said.  

Neptune Medical, headquartered in Silicon Valley, develops endoscopy devices based on its Dynamic Rigidization platform, which is designed to improve control and stability during minimally invasive procedures.

The FDA clearance of Triton 1 represents Neptune Medical’s move toward the commercial deployment of robotic technology in colonoscopy, with the company continuing to evaluate how robotic control can be integrated into endoscopist workflows and complex gastrointestinal procedures.