Augmedics gained FDA approval for its wireless headset on Dec. 23. The headset uses augmented reality for surgical guidance.
A startup touting its headset that gives surgeons “x-ray vision” recently secured approval from the Food and Drug Administration. Augmedics received FDA 510(k) clearance on December 23 for its augmented reality system, which helps surgeons visualize a patient’s 3D spinal anatomy during a procedure.
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More surgeons are donning headsets as a growing number of augmented reality systems are approved for surgical planning and procedures. For example, Philips has debuted its own AR technology for minimally-invasive surgery, and a swath of startups are developing similar tools.
Augmedics CEO Nissan Eimelech said the company’s tech was different because all of the components are in a lightweight, wireless headset and the device could be sold at a lower cost due to its smaller footprint.
“We expect to be a welcome solution to hospitals and surgery centers,” Eimelech wrote in an email.
Augmedics’ headsets project a 3-D image of CT scans on a surgeon’s retina. Instead of having to look over at a screen, surgeons can use instruments and implants while looking directly at the patient. The headsets also feature a camera that determines the position of surgical tools, with a trajectory superimposed on the CT data.
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Eimelech said he came up with the idea after selling surgical navigation systems.
“After selling surgical navigation systems, and spending so much time on the process, I was frustrated to see that the surgeons hardly used them,” he wrote. “I wanted to solve the problems of traditional navigation systems, such as line of sight issues, bulky OR equipment, and a burdensome capital investment. I wanted to give the surgeons superpowers, as in ‘x-ray’ vision, and after investigating, Augmented Reality was our solution and started our journey five years ago.”
The Chicago-based company submitted evidence from a laboratory study conducted with Rush University Medical Center. Researchers placed 93 screws in the thoracic and sacro-lumbar areas of cadavers, showing 98.9 percent accuracy when comparing the actual position and trajectory of the screws versus the virtual position. A similar study was published last year in the Journal of Neurosurgery.
“The ability that Augmedics’ xvision (headset) provides to visualize the patient’s spinal anatomy in 3D, coupled with live CT images as a retina display, is game changing,” Dr. Frank Phillips, an investigator in the study and professor of orthopaedic surgery at Rush University Medical Center, said in a news release. “The efficiency and accuracy this augmented reality technology enables in placing spinal implants without looking away from the surgical field – as well as the ability to “see the spine” through the skin in minimally invasive procedures – differentiates the xvision from conventional spinal navigation platforms.”
Augmedics plans to begin distributing its headsets starting in 2020. In the future, the company plans to consider additional applications for its headsets beyond spinal surgery.
This story has been updated with comments from CEO Nissan Eimelech
Photo credit: Augmedics
