Gauss Surgical Receives CE Mark Approval for Triton
Mobile Platform to Monitor Surgical Blood Loss Now Approved for Commercial Market Entry in Europe
Los Altos, Calif. -- Gauss Surgical, Inc. announced today that the company has received CE (Conformité Européenne) Mark for its Triton System™ for iPad, the world’s first and only mobile platform for real-time monitoring of surgical blood loss. This milestone allows Gauss to market and sell its system throughout Europe and other regions that require the CE Mark.
Additionally, the company received certification that its Quality System is in compliance with ISO 13485 for design, development, marketing and sales of image processing software and accessories for estimation and monitoring of external blood loss. Certification to this standard is one of the key regulatory requirements for a CE Mark in the European Union as well as requirements in other international markets. The Triton system received clearances from the U.S. Food and Drug Administration (FDA) in May 2014 and March 2015, and is currently being implemented across several health systems in the United States.
“We have had a strong response to our technology to date in the United States. While our immediate commercial focus remains in the U.S., receiving the CE Mark is an important step towards enabling medical facilities throughout Europe to adopt our solution,” said Milton B. McColl, M.D., Chief Executive Officer of Gauss Surgical. “Blood management is indeed a worldwide healthcare priority, and we are eager to ultimately bring the benefits of real-time blood loss monitoring to bear on a global scale.”
By leveraging the power of mobile devices in combination with proprietary software, Triton may help to reduce unnecessary transfusions and the associated costs and complications. It offers the potential to not only improve patient outcomes but also conserve health care resources.
Using the iPad camera, the Triton system scans surgical sponges and blood bearing canisters 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, and was integrated with Epic (a major electronic health record system) for the first time at the Hackensack University Medical Center in October.