Gauss Surgical has received the CE (Conformité Européenne) mark for its Triton System for iPad, which provides real-time monitoring of surgical blood loss.

The company has also 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.

Triton can help reduce unnecessary transfusions and the associated costs and complications.The Triton system has previously received clearances from the U.S. FDA, and is currently being implemented across several health systems 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., CEO 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.”

Using the proprietary software, Triton can help 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.

The system relies on the iPad camera to scan 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 operating room in real-time. Triton is fully HIPAA compliant, and was integrated with Epic EHR for the first time at the Hackensack University Medical Center in October.

To date, Gauss Surgical has raised around $11 million. Its previous round, totaling $3.3 million, was secured in August of this year.