FDA clears iPad medical app for measuring surgical blood loss in canisters

By Aditi Pai
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Gauss Surgical canisterLos Altos, California-based Gauss Surgical has received an FDA 510(k) clearance for its Triton iPad app, which can now estimate the surgical blood loss in canisters that hold blood.

Surgeons can estimate blood loss in surgical suction containers using the iPad's camera. The app enables the user to take pictures of the surgical canisters and then send the images up to the cloud for analysis. At that point, an algorithm estimates the hemoglobin content and the blood loss "regardless of confounding factors such as saline/irrigation fluid, ambient lighting variations, and hemolysis (red cell rupture)", the company explains.

“In developing the Triton Canister algorithm, we discovered various factors that alter the visual appearance of blood in a container, and confound our ability to measure it," Gauss Surgical Founder and CTO Siddarth Satish said in a statement. "Our challenge was to develop a highly accurate solution while preserving the simplicity that is critical to our users’ experience in the operating room." 

Gauss Surgical's Triton app has already received an FDA 510(k) clearance, in May 2014, for a feature in the app that uses the iPad’s camera to estimate the amount of blood lost during a surgery with surgical sponges. The system analyzes surgical sponges that have blood on them, counts how many sponges there are, and sends data from the app to a cloud server. The app then displays totals for estimated blood lost, estimated hemoglobin lost, and a sponge count.

Gauss' original sponge management app, Pixel, received FDA clearance in 2012.

At the end of 2014, Gauss Surgical raised $1.5 million, which brought their total funding to date to $7.7 million. The company was also a participant in the StartX Stanford University incubator in 2012.

In August 2014, Gauss Surgical completed its first pilot using the app at Magee-Womens Hospital of the University of Pittsburgh Medical Center (UPMC). Doctors at UPMC are using the app to estimate blood loss during cesarean section surgeries. Gauss Surgical CEO Dr. Milton B. McColl also added that the pilot at UPMC represented the beginning of the commercial phase for the company.

The app is currently being implemented at Cedars-Sinai Medical Center, UC Irvine Healthcare, and the Memorial Care Health System, according to Gauss.