FDA Clears Augmented Reality Device to Help Surgeons Prep for Procedures

The automotive industry has had quite an influence on the medical technology industry in recent years, impacting everything from business strategy to outsourcing models and long-term growth plans. But it’s not the only sector exerting its influence on healthcare.

The airline industry is doing its part as well, as evidenced by a recent U.S. Food and Drug Administration (FDA) clearance for Surgical Theater LLC. The firm was inspired by flight simulators to develop its augmented reality imaging devices to help physicians prepare for surgery, with the goal of improving clinical outcomes in complex procedures.

The company’s FDA-cleared Surgical Navigation Advanced Platform (or SNAP) gives surgeons guidance, based on the patient’s computed tomography or magnetic resonance imaging scan, to determine the safest and most efficient approach to remove brain tumors and perform vascular surgery as well as analyze each critical step before they make it.

The augmented reality component gives surgeons the ability to simulate and plan for potential scenarios and adds to their clinical insight. It allows surgeons to rotate an image or make it semi-transparent to get a perspective behind arteries and other structures.
 ”We have used the SNAP in the operating room in a handful of surgeries. The SNAP’s realistic 3-D imaging is one-of-a-kind and has been introduced as an integrated OR device for the first time at our medical center,” said Warren R. Selman, M.D., chairman, Department of Neurological Surgery at University Hospitals Case Medical Center in Cleveland, Ohio. “It is just like watching a football game when multiple cameras are located around the arena and an editor can freeze the image, rotate, zoom in, zoom out and see things that he could not otherwise see. In my recent surgeries, I was able to pause the navigation scene during the surgery to rotate the image and to verify that I removed the entire tumor and to make sure that I was within a safe distance from a vital artery while removing the tumor. With the SNAP connected to the O.R. (operating room) navigation platform, the O.R. team coordination is enhanced, and we are utilizing the best imaging technology tool to benefit our patients.”

SNAP follows the development of Surgical Theater’s first pre-surgery simulation device—Surgical Rehearsal Platform (SRP), a system used by doctors more than 500 times to date, the company estimates. SRPs have been installed in various research and teaching hospitals across the United States, including University Hospitals Case Medical Center; University Hospitals Rainbow Babies and Children’s Hospital in Cleveland; the Ronald Reagan UCLA Medical Center in Los Angeles, Calif.; the Mount Sinai Hospital in New York, N.Y.; the Mayo Clinic in Rochester, Minn.; NYU Langone Medical Center in New York, N.Y.; and others.
Surgical Theater also is developing a platform for spine surgeries.

“We are excited to expand our offerings beyond planning and rehearsing surgeries outside the operating room,” said Moty Avisar, Surgical Theater CEO and co-founder. “The SNAP allows us to connect to the operating room navigation system and become a part of the surgery as it’s performed, enabling a surgeon and operating room team to achieve their goal of delivering the best care and outcome for the patient.”

Surgical simulators have become increasingly sophisticated tools, produced by software developers such as Simbionix and Immersive Touch. The technology also is helping train future surgeons by creating a more effective way to pinpoint the strengths and weaknesses of students’ technique so they can master different types of operations. It’s also helped reduce the reliance on animals for clinical practice.

In addition, the simulation devices are designed to prevent some of the medical errors that contribute to the $1.3 billion in medical liability settlements, according to one study.