Gauss Surgical Receives FDA Clearance for Second Generation Triton for Real-Time Monitoring of Surgical Blood Loss

This study demonstrated that the use of Triton was significantly more accurate than either visual estimation or the gravimetric method to determine blood loss.

Gauss Surgical, Inc. announced today that the company received U.S. Food and Drug Administration (FDA) clearance for its second generation Triton OR system, a mobile platform for accurate, real-time estimation of surgical blood loss.

Measurement of blood loss is a challenge that has plagued surgical departments for decades. Current monitoring methods have significant shortcomings, such as visual estimation, which is subjective and unreliable, and the gravimetric method, which is inaccurate and workflow intensive with low rates of compliance.

For cesarean deliveries in particular, both visual estimation and gravimetric methods are especially unreliable because sponges and canisters contain unknown amounts of amniotic fluid, saline and other non-sanguineous fluids that confound the measurements. This often results in underestimations, which can delay the diagnosis of post-partum hemorrhage (PPH) or overestimations, which can result in unnecessary transfusions.

Triton OR offers a mobile platform for accurate, real-time estimation of surgical blood loss throughout the procedure. Triton OR uses a mobile app to capture images, which are processed using cloud-based computer vision and machine learning algorithms to rapidly estimate blood loss on surgical sponges and suction canisters. The system has an intuitive iPad-based user interface, requires minimal training, and seamlessly integrates into existing surgical workflow.

The FDA first cleared the Triton OR system in May 2014. Features new to the second-generation system include automatic sponge-capture via an infrared 3-D sensor that attaches to…

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