ST. LOUIS (KMOX) -- A local bio-tech start-up which aims to revolutionize the operating room recently received FDA clearance to begin marketing its holograms-for-surgeons technology.
"It's really an exciting time for us," SentiAR President and CEO Berk Tas said.
The 510(k) clearance from the Food and Drug Administration means the technology, which is called "CommandEP," can now be marketed and sold in the U.S. It could start showing up next year in hospitals across the country.
The agency "knows that this has the potential to impact patients' lives in a positive way.. definitely physicians' lives in a positive way. But, ultimately, FDA's objective is to ensure only systems that are safe enough, have been tested thoroughly and meet their stringent standards, get to the market," Tas said. "This is a long process."
The patented technology gives surgeons a real-time, 3D view of the heart and any catheters which are inside of the patient being operated on. Doctors wear a Microsoft HoloLens headset to view and manipulate the image.
"This has never been done before. We are truly breaking new ground," Tas said.
A study from Barnes-Jewish and St. Louis Children's Hospitals found that being able to examine the holographic heart image before operating on the real thing resulted in a 44 percent reduction in "navigation errors."
"Ultimately, the objective is to increase physicians' accuracy," the CEO said.
SentiAR was created out of research at Washington University and was backed by St. Louis investment firms BioGenerator and Capital Innovators.
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