A system that uses an iPad camera and cloud analytics to help anesthesiologists monitor how much blood a patient is losing during surgery has gotten the FDA’s OK for use in the operating room.
Mobile health startup Gauss Surgical said today it plans to begin rolling out its Triton Fluid Management System to hospitals next month.
The Triton 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 the OR staff with an estimate of how much blood has been collected in the sponges. That can be helpful to them 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 risk of infection or other complications.
“Over or under estimation of blood loss may lead to wrong clinical decision,” said Dr. Aryeh Shander, chief of the Department of Anesthesiology at Englewood Hospital and Medical Center in New Jersey, 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, said Chief Operating Officer Eric Lindquist in an email.
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 instead the company went through the de novo classification process, which took about 15 months, he said.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Gauss was founded in 2011 by Siddarth Satish, a graduate of Stanford’s biodesign program and Milton McColl, a former pro-football player-turned VC-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.
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