Gauss Surgical Announces FDA 510(k) Clearance of Triton Canister App for Accurate Surgical Blood Loss Monitoring

Provides Estimates of Blood Loss on Surgical Sponges, and now Canisters, in Seconds 

Los Altos, Calif., March 16, 2015 – Gauss Surgical today announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Triton Canister App, the second core product in its Triton System™ portfolio, the world’s first and only 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 Triton Canister App provides a fast, 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 such as saline/irrigation fluid, ambient lighting variations, and hemolysis (red cell rupture).

“In developing the Triton Canister algorithm, we discovered various factors that alter the visual appearance of blood in a container, and confound our ability to measure it. Our challenge was to develop a highly accurate solution while preserving the simplicity that is critical to our users’ experience in the operating room,” said Siddarth Satish, Founder and Chief Technology Officer of Gauss Surgical.

The result was an App that simply requires the user to take a picture of the canister - the software handles the rest. 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 Triton Canister App 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., Chief Executive Officer of Gauss Surgical. “Typically, anesthesiologists and surgeons visually guesstimate the blood loss in suction containers, which has been shown to be highly inaccurate. We believe that providing more accurate estimates aids in clinical decision making, particularly regarding the use of blood products. This can have a significant impact on patient safety and overall quality of care.”

Products in the Triton System portfolio feature an intuitive iPad interface, require minimal training, and seamlessly integrate into existing surgical workflow. The system is fully HIPAA compliant. The Triton System is being implemented at Cedars-Sinai Medical Center, UC Irvine Healthcare, the Memorial Care Health System, and other leading institutions around the United States.

About Gauss Surgical

Founded in 2011 and headquartered in Los Altos, Calif. Gauss is developing a mobile platform for accurate, real-time monitoring of surgical blood loss. The system uses sophisticated cloud-based computer vision algorithms to estimate blood loss. This first-of-kind system gives operating room personnel the means to estimate blood loss in real time. For more information, go to http://www.gausssurgical.com.

Media contact:

Stephanie Tomei
tomei.stephanie@gmail.com

408 234-1279