FDA cleared Neptune Medical's Triton 1 robotic endoscopy system for diagnostic and therapeutic procedures throughout the colon. The clearance is K260503, product code FDF, with a decision date of September 3. The company announced it 13 days later, on September 16. Triton 1 is Neptune's second cleared product, after the Pathfinder rigidizing overtube.
The company points to CARE 1, a 50-patient first-in-human study presented at Digestive Disease Week this year. Investigators reported 100 percent cecal intubation and no adverse events. Adenoma detection came in at 54.2 percent, against a 35 percent quality threshold. Clinician workload scored 67 percent lower than manual colonoscopy on the NASA-TLX scale. No case needed patient repositioning, abdominal pressure or conversion to a manual scope.
Both products run on the same Dynamic Rigidization platform, which stiffens a flexible shaft on demand. Pathfinder has been used in more than 15,000 patients. Triton is not on sale yet in the US, the EU or elsewhere, according to Neptune's own product page.
Fifty patients is a thin base for a robotic platform, so the predicate does more work here than the trial does. Alex Tilson founded the company and runs it. Fred Moll, who built Intuitive Surgical and Auris Health, chairs the board.