Augmedics has received the Food and Drug Administration (FDA) 510(k) clearance of the new CT-to-fluoroscopy (CT-Fluoro) registration method for its xvision spine system.
Navigating off using preoperative computed tomography (CT) scans and fluoroscopic images is made possible through this method, bypassing the need for 3D intraoperative imaging, which has been a significant obstacle to the adoption of navigation technology in spine surgery.
The initial spine surgical case with the new registration method was completed by Dr Frank Phillips at Rush University Medical Center in Chicago.
The company is planning a limited release of the xvision's CT-Fluoro registration within the selected areas until the year's end, with a full commercial launch anticipated in the US market next year.
Navigation in spine surgery is associated with improved reduced radiation exposure, accuracy, and additional minimally invasive procedures.
However, the dependency on 3D intraoperative scans, which require costly and bulky imaging systems, has limited its use.
Augmedics' CT-Fluoro registration aims to overcome this barrier, given that more than 50% of the US hospitals lack access to the necessary 3D imaging equipment.
The development of the registration application is built upon the expansion of Augmedics' AI capabilities, which were launched last year.
This method provides an open platform that offers surgeons the flexibility to choose between preoperative CT and intraoperative 3D imaging for registration.
Augmedics interim CEO Gwen Watanabe said: “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. Fluoro enables surgeons to unlock the benefits of AR [augmented reality] navigation for patients in any facility.
“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.”
