Gauss Surgical announces FDA approval of first mobile platform for real-time estimation of surgical blood loss
Gauss Surgical has announced that the Triton Fluid Management System™, the world's first and only mobile platform for real-time estimation of surgical blood loss on surgical sponges, has received U.S. Food and Drug Administration (FDA) approval. Triton provides physicians a first of its kind device to accurately estimate intra-operative blood loss through the use of sophisticated cloud-based computer vision algorithms to estimate blood loss and hemoglobin mass on surgical sponges.
Current methods of estimating blood loss during surgery based on visual estimation are known to be inaccurate. Clinical studies indicate that the use of blood products beyond a level deemed medically necessary can increase complication rates, ICU days, and overall length of hospitalization.(1, 2) Overuse can also substantially increase the cost of care. The cost of a single unit of red blood cells averages as much as $1,100 when administration and supply costs are included.(3, 4) A recent study by Premier, a healthcare performance improvement alliance of approximately 2,900 U.S. community hospitals and 100,000 alternate sites, looked at 464 member hospitals and concluded that blood utilization represents the eighth highest savings opportunity for hospitals - a savings of $1.06 million per hospital, per year. (5)
"Blood loss in surgery has always been estimated and in situations of large blood loss, erroneous," said Aryeh Shander, M.D., FCCM, FCCP, Chief, Department of Anesthesiology, Critical Care Medicine, Hyperbaric Medicine and Pain Management, Englewood Hospital and Medical Center, Englewood, NJ. "Over or under estimation of blood loss may lead to wrong clinical decisions. This new technology avails us the ability to more accurately account for blood loss with the potential to not only improve patient outcomes but also conserve healthcare resources."
"FDA approval marks a significant milestone for the company and brings a truly novel product into the surgical environment," said Milton B. McColl, M.D., Chief Executive Officer of Gauss Surgical. "The Triton Fluid Management System has the potential to improve the quality of patient care and drive significant savings to hospitals through better utilization of blood products and reduced length of stay."
At its core, Triton uses standard off-the-shelf mobile computing technology in combination with cloud storage. Using the iPad camera, the system scans surgical sponges that are covered in blood and sends the images to the cloud where image-processing algorithms estimate the amount of blood contained on that surface and sends it back to the OR in real-time. Triton features an intuitive iPad interface, requires minimal training, and seamlessly integrates into existing surgical workflow. The system is fully HIPAA compliant.
"We identified a critical unmet need for a fast and accurate way to estimate blood loss on sponges in the operating room," said Siddarth Satish, Gauss Founder and Chief Technology Officer. "By leveraging the power of mobile devices in combination with our proprietary software, we're fulfilling that need with the potential to reduce unnecessary transfusions and the associated costs and complications."
The approval went through the de novo classification process, a regulatory path for some low- to moderate-risk medical devices that are not substantially equivalent to an already marketed device. Under the de novo petition review process, the FDA reviewed data from two clinical studies that demonstrated the accuracy of the device.