Augmedics Announces FDA Clearance, Completion of First Surgery for New CT-Fluoro Registration

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CHICAGO--(BUSINESS WIRE)--Nov 19, 2024--

Augmedics, a pioneer in augmented reality (AR) surgical navigation, today announced FDA 510(k) clearance of a new registration method for its xvision Spine System®. The xvision CT-to-fluoroscopy (CT-Fluoro) registration method allows surgeons to navigate off a preoperative CT scan and fluoroscopic images from a standard 2D C-arm, eliminating the need for 3D intraoperative imaging, a common barrier to navigation adoption.

Augmedics also shared the successful completion of the first surgical case using its new CT-Fluoro registration by Dr. Frank Phillips at Rush University Medical Center in Chicago. Dr. Phillips, who completed the world’s first AR navigated minimally invasive spine surgery in June 2020 and views augmented reality as a “game-changer” for spine surgeons, was excited by the new registration method and reports the patient is doing well.

“It was terrific,” said Dr. Phillips. “It’s so much more efficient than bringing in the 3D scanner and the quality of the 2D and 3D visualization during navigation was unparalleled. The evolution of the technology since our first cases is incredible. The ability to navigate off a preoperative CT that is converted to real time visualization with two intraoperative fluoroscopic images provides a simple, elegant solution for surgeons who want to bring AR navigation into their workflow without the need for 3D imaging.”

Expanded access for AR navigation

The benefits of navigation in spine surgery – among which surgeons cite improved accuracy, reduced radiation exposure, and more minimally invasive procedures – are well documented. Today, most navigation solutions are dependent upon a 3D intraoperative scan of patient anatomy taken during surgery. Yet the 3D imaging systems that produce these scans are often expensive, unwieldy, and scarce; data suggests more than half of US hospitals do not have access to these machines, restricting their ability to use advanced navigation.

“Our mission at Augmedics is to bring the proven benefits of navigation to as many surgeons and as many patients as possible. By removing the 3D imaging requirement, we’re removing a major barrier to adoption,” said Gwen Watanabe, Augmedics Interim CEO. “CT-Fluoro enables surgeons to unlock the benefits of AR navigation for patients in any facility.”

The foundations of Augmedics’ CT-Fluoro registration application rest on an expansion of the company’s proprietary artificial intelligence (AI) capabilities launched in Spring 2023. CT-Fluoro also builds on Augmedics’ open platform with additional imaging and registration flexibility, allowing surgeons to choose between pre-op CT and intraoperative 3D imaging and registration.

“The beauty of our platform is that it puts the surgeon fully in the driver’s seat,” said Watanabe. “With Augmedics, surgeons can choose the instruments, implants – and now imaging – to best fit the needs of each patient and deliver the best outcomes possible.”

Augmedics is conducting a limited launch of xvision’s CT-Fluoro registration at select sites through the end of the year and plans a full commercial launch to the US market in Spring 2025.

About Augmedics

Augmedics pioneers cutting-edge augmented reality technologies to improve surgical outcomes. The company’s revolutionary xvision Spine System® allows surgeons to see patients’ anatomy as if they have “x-ray vision” and accurately navigate instruments and implants during spine procedures. The first-of-its-kind, FDA-cleared xvision has been used to treat over 8,500 patients and implant more than 45,000 pedicle screws across 25 US states. Augmedics has received numerous awards and honors. To learn more, visit www.augmedics.com.

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SOURCE: Augmedics

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PUB: 11/19/2024 09:15 AM/DISC: 11/19/2024 09:14 AM

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