Gauss Surgical’s Triton Canister app gets the FDA 510(k) clearance

Gauss Surgical

Gauss Surgical has received FDA 510(k) clearance for its Triton Canister app, the second core product in its Triton System portfolio, the mobile platform for real-time monitoring of surgical blood loss. Now, in addition to estimating blood loss on surgical sponges, the system can accurately estimate blood loss in blood bearing canisters, giving clinicians a better picture of overall surgical blood loss.

The HIPAA-compliant Triton System is being implemented at Cedars-Sinai Medical Center, UC Irvine Healthcare and the Memorial Care Health System.The Triton Canister app provides an easy and accurate means of estimating blood loss in surgical suction containers. Using the iPad camera, the system captures snapshots of surgical canisters and sends the images to the cloud where sophisticated algorithms estimate the hemoglobin content and the blood loss regardless of confounding factors. The server then sends the estimated blood loss back to the operating room in an encrypted manner, where it is displayed in real-time. The application can be used simultaneously with multiple canisters via its built-in QR code management system.

“With this FDA clearance, we have extended the Triton System’s ability to give clinicians a better assessment of overall blood loss during surgery,” said Milton B. McColl, M.D., CEO of Gauss Surgical. “This can have a significant impact on patient safety and overall quality of care.”

The Triton System is fully HIPAA compliant; it is being implemented at Cedars-Sinai Medical Center, UC Irvine Healthcare, the Memorial Care Health System, and other leading institutions around the United States.