Blood Loss Monitoring Goes Mobile with FDA App Approval

Medtech startup Gauss Surgical has received FDA approval to market its Triton Fluid Management System to help anesthesiologists monitor how much blood a patient is losing during surgery.

The system uses an iPad's camera to scan images of blood-soaked surgical sponges. The app uploads these images to a set of cloud-based algorithms that estimate the amount of blood and hemoglobin loss, and keeps track of the number of sponges for retained foreign object vigilance. The Triton system provides the OR staff with an estimate of how much blood loss must be replaced in less than 10 seconds. The system features an intuitive iPad-based interface and is certified HIPAA compliant.

Blood transfusions aren't the exact science that one might expect, given the number of units transfused annually and the importance of those transfusions to patients. Traditionally surgeons keep track of a patient's blood loss by weighing sponges, or simply estimating by eye. A study published in May 2013 in The Lancet found that blood transfusions are still being overused during common heart surgery even though there is compelling evidence demonstrating the dangers of unnecessary blood transfusions.

The Triton Fluid Management System is sufficiently novel that, although the firm originally tried to get it approved by the 510(k) process, it eventually had to conduct two clinical studies that compared the Triton system to the traditional methods. Eric Lindquist, Gauss Surgical's COO, told Deanna Pogorelc of MedCity News in an email that the Triton system demonstrated superior performance compared to visual and weighing methods, although the de novo classification process took about 15 months.

According to the company's website, Los Altos, CA-based Gauss Surgical Inc. was founded in 2011 and was spun out of Stanford and the University of California, San Francisco (UCSF). The firm says its vision is the leveraging of mobile devices in the OR as medical devices to significantly improve the quality of perioperative care.

Stephen Levy is a contributor to Qmed and MPMN.