Polaris AR earns FDA clearance for mixed reality surgical tech


Mixed reality surgical guidance company Polaris AR has earned FDA clearance for its Stellar Knee, the first clearance secured by Polaris AR. 

The Stellar Knee uses a mix of tracking algorithms and spatial computing software to measure and capture clinical data on hard and soft tissue anatomy, enable sub-millimetric intraoperative planning and provide precise resection accuracy and guidance.

The Stellar Knee requires minimal physical setup in the operating room: just a mixed reality headset that acts as a 3D spatial computing tool, according to a Nov. 3 press release. 

The Stellar Knee then acquires patient-specific anatomic data, digitizing that information into holographic displays. By capturing the surgeon's field of view, the Knee creates a real-time digital data exchange between the surgeon and the technology that can inform clinical decisions. 

The device enables surgeons to make quick assessments and micro-adjustments to the surgical plan.

"Technological advancements don't always correlate with improvements within the OR. Stellar Knee is an exception. With no footprint outside of the headset, no computers, or stalls, it does the thing it was designed to do brilliantly well — empower me to focus on what matters most, the surgery, and to be confident in the decisions I make," Francis Gonzales, MD, professor of orthopedic surgery at the University of California San Diego, said in the release. 

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