FDA Approves App That Turns iPads Into Blood Loss Monitors

A system that uses an iPad camera and cloud analytics to help anesthesiologists monitor a patient’s blood loss during surgery has received approval by the U.S. Food and Drug Administration (FDA) for use in the operating room.

Mobile health startup Gauss Surgical’s Triton Fluid Management System app uses an iPad camera to scan surgical gauze covered in blood, and sends those images to the cloud where its algorithms go to work. In real-time, the app provides operating room staff with an estimate of the amount of blood that has been collected in the sponges. That can be helpful to clinicians when deciding if, or when, to start a blood transfusion.

Traditionally, surgeons keep track of a patient’s blood loss by weighing sponges, or just guessing based on what they see. It’s not very accurate, and as a result, studies have suggested that blood transfusions are overused during some surgeries. Any time blood is transfused, the receiving patient is exposed to the risk of infection or other complications.

“Over or under estimation of blood loss may lead to wrong clinical decisions,” Aryeh Shander, M.D., chief of the Department of Anesthesiology at Englewood Hospital and Medical Center in Englewood, N.J., said in a statement. “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.”

Gauss validated its technology with two clinical studies in which it demonstrated superior performance compared to visual and weighing methods, Chief Operating Officer Eric Lindquist said.

The Los Altos, California-based company initially submitted a 510(k) request to the FDA in the summer of 2012, but after about six months of processing it was determined that it was not substantially equivalent to a predicate device, Lindquist said. So the company went through the de novo classification process, which took about 15 months, he said.

Gauss was founded in 2011 by Siddarth Satish, a graduate of Stanford’s biodesign program and Milton McColl, a former pro-football player-turned venture capitalist-turned medical device entrepreneur. They were early participants in the StartX accelerator and followed that up with a $6.2 million Series A round from LifeForce Ventures, Promus Ventures and Taube Investment Partners.