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

Data Published in American Journal of Perinatology Reports and Presented at the SOAP 49th Annual Meeting Highlight Triton’s Accuracy in Measuring Blood Loss During Cesarean Section

Los Altos, Calif.June 22, 2017 - 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 the iPad and a Bluetooth scale that enables the weighing of additional blood loss components. Improvements also include an upgrade to the iPad Pro platform for a higher resolution image, larger screen and faster processing speed. Overall, the new system provides an enhanced user experience and more streamlined workflow while delivering the same high-level of accuracy of estimated blood loss.

“Unrecognized blood loss contributes significantly to the issue of post-partum hemorrhage related morbidity and mortality,” said Griffeth Tully, M.D., Chief Medical Officer at Gauss. “Triton provides a more precise, objective metric for estimating blood loss and assessing hemorrhage status, allowing clinicians to recognize and intervene sooner. We believe hospitals can more effectively implement their maternal safety hemorrhage bundle if they have an accurate way to estimate blood loss. Consequently, many unnecessary maternal deaths may be prevented with Triton playing an important role in monitoring, early recognition and response assessment.”

At the 49th Annual Meeting of the Society for Obstetric Anesthesia and Perinatology (SOAP) held May 10-14 in Bellevue, Washington, Sahar Doctorvaladan M.D., from Santa Clara Medical Center, presented findings from a study comparing the accuracy of Triton versus visual and gravimetric methods during cesarean deliveries. Commenting on the findings, study investigator David C. Lagrew, M.D., from Women’s Health Institute at St. Joseph Hoag Health, said, “This study demonstrated that the use of Triton was significantly more accurate than either visual estimation or the gravimetric method to determine blood loss. These data highlight the challenges we frequently experience with both visual estimation and gravimetric QBL in C-sections, while recognizing a new, promising technology for blood loss estimation.” The data were published in the April 2017 American Journal of Perinatology Reports.

Many of the leading obstetrics and gynecology organizations including the American College of Obstetrics and Gynecology (ACOG) and Association of Women's Health, Obstetric, and Neonatal Nurses (AWHONN), have recommended quantified blood loss (QBL) as a tool for early recognition of hemorrhage. In addition, various state organizations have initiatives underway to help clinicians better recognize and respond to postpartum hemorrhage, including the California Material Quality Care Coalition (CMQCC) and Department of Heath of the state of Illinois (IDPH), which recently instituted a state-wide mandate requiring hospitals to implement a quantitative blood loss method by May 2017.

As part of the company’s efforts to aid in early recognition of obstetric hemorrhage, Gauss launched Triton L&D in the fourth quarter of 2016 to streamline quantified blood loss in vaginal and postpartum recovery settings. Triton L&D integrates a Bluetooth scale with an iPad app that customizes the list of blood absorbent items with pre-set dry weights, automatically calculates blood loss of weighed items and allows for batch weighing and integration of v-drape volume. Triton L&D, coupled with Triton OR, provides a comprehensive solution for hospital obstetric departments.

“Triton’s unique ability to accurately estimate blood loss helps clinicians make more informed treatment decisions and drive improved outcomes for patients, while creating value for hospitals,” said Siddarth Satish, founder and chief executive officer of Gauss Surgical. “We are excited to be partnering with an expanding number of hospitals as we continue to focus on developing innovative solutions that impact the delivery of cost-effective care.”

About Gauss Surgical Gauss Surgical is a medical technology company based in Los Altos, California that develops novel FDA-grade mobile applications for patient monitoring, with a focus on computer vision and machine learning applications. Gauss’s flagship product, Triton, is the world’s first real-time monitor for surgical blood loss. For more information, go to http://www.gausssurgical.com.