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FDA 510(k) clearance · Neptune Medical · Gastroenterology

Triton 1 System

FDA clears a robotic endoscopy system for procedures throughout the colon.

CompareNeptune Medical press release
Cleared · 510(k)

Triton 1 System

Neptune Medical · Gastroenterology

Type
Surgical system
FDA route
510(k) clearance
Used by
Endoscopists (gastroenterologists)
Bottom line for your practice
55s read

Gastroenterologists may see a robotic option for screening, surveillance and diagnostic colonoscopy, as well as more complex procedures such as EMR and ESD. The evidence so far is a first-in-human study, and the company describes this generation as a step toward commercialization.

What it is
A robotic system built for flexible endoscopy, designed to give the endoscopist robotic precision, stability and control throughout the entire colon.
Indicated for
Patients undergoing diagnostic and therapeutic procedures throughout the colon.
What changes
The company contrasts the system with manual endoscopy, saying current endoscopes are difficult to control and that instability can lead to missed adenomas. CARE 1 results were set against an industry adenoma detection threshold of 35% and against manual colonoscopy for ergonomic burden.
Evidence
Design not reportedCARE 1The Triton 1 System met its primary endpoints, with no adverse events and 100% cecal intubation. It showed an adenoma detection rate of 54.2%, compared to the industry threshold of 35%, and a 67% lower average burden for endoscopists compared to manual colonoscopy based on the NASA-TLX score.The source does not describe a clinical study or its design. Common for cleared devices, which can rest on equivalence to a predicate.
Watch for
The release lists no contraindications or warnings. The only clinical data cited are from a first-in-human study, and an investigator quoted in the release refers to additional clinical research on the path to commercialization. The release does not describe the study's design or number of patients.
FDA decision
  1. 510(k)Cleared
  2. De NovoGranted
  3. PMAApproved
510(k) clearance. Cleared, not approved. The FDA found the device substantially equivalent to one already on the market (its predicate). Clinical trials are often not required.

Clinical summary

The Triton 1 System is a robotic flexible endoscopy system indicated for diagnostic and therapeutic procedures throughout the colon. In the first-in-human CARE 1 study, the system met its primary endpoints with no adverse events and 100% cecal intubation, and showed an adenoma detection rate of 54.2%. An investigator quoted in the release anticipates additional clinical research as the system moves toward commercialization.

From the source 9

Neptune Medical press release

The Neptune Medical press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. Sep 16, 2026 8:00 AM Eastern Daylight Time

    Backs · Date 2026-09-16 is the announcement date (the release does not state the FDA decision date)

  2. BURLINGAME, Calif.--(BUSINESS WIRE)--Neptune Medical, a company creating the future of endoscopy, today announced FDA clearance for its Triton 1 System, a robotic system purpose-built for next-generation flexible endoscopy and indicated for diagnostic and therapeutic procedures throughout the colon.

    Backs · FDA clearance and indication

  3. Triton 1 Robotic Endoscopy System 510K-Cleared for Diagnostic and Therapeutic Procedures Anywhere in the Colon

    Backs · Pathway 510(k)

View all 9 lines

  1. The Triton 1 System is designed to elevate any endoscopist’s capabilities for screening, surveillance, and diagnostic colonoscopies, as well as other more complex procedures in the colon, such as endoscopic mucosal resections (EMRs) and endoscopic submucosal dissections (ESDs).

    Backs · Uses: screening, surveillance, diagnostic colonoscopy, EMR and ESD

  2. The first-in-human CARE 1 study was presented earlier this year at Digestive Disease Week® (DDW) 2026. The study showed that the Triton 1 System met its primary endpoints, with no adverse events and 100% cecal intubation.

    Backs · CARE 1 first-in-human; primary endpoints met; no adverse events; 100% cecal intubation

  3. The robotic system also demonstrated a high adenoma detection rate (ADR) of 54.2%, compared to the industry threshold of 35%.

    Backs · Adenoma detection rate 54.2% vs 35% threshold

  4. It was also effective in creating a highly favorable ergonomic environment for endoscopists, with a 67% lower average burden compared to manual colonoscopy (based on the NASA-TLX score) and no patient repositioning, abdominal pressure, or conversion to manual colonoscopy.

    Backs · 67% lower average burden (NASA-TLX)

  5. I look forward to participating in additional clinical research of the system that will support its progress along the path to commercialization.

    Backs · Further research planned before commercialization

  6. Endoscope instability can lead to incomplete visualization of the colon, missed adenomas (pre-cancerous lesions), and ultimately, an increased risk of cancer development.

    Backs · Comparison with manual endoscopy

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