FDA greenlights Augmedics’ AR system for spinal surgery
Augmedics Inc., a Chicago-based startup focused on augmented reality (AR) applications in health care, has scored a 510(k) clearance from the U.S. FDA for its Xvision Spine system. The company launched the device, which provides surgeons with X-ray quality insights into a patient’s anatomy and real-time surgical navigation, on Monday, with distribution slated to begin in the new year.

While the FDA has cleared other AR products, Xvision Spine (XVS) is the first to be indicated for guided surgery. “There is no other device that is using both the technology of augmented reality on a headset and has the full capabilities of surgical navigation, of tracking the surgical instrument very precisely to locate and guide the surgeon throughout the surgery,” Nissan Elimelech, Augmedics’ founder and CEO, told BioWorld MedTech. He added that initial shipments of headsets and systems to hospitals will begin in the first quarter of 2020.

The FDA cleared the XVS system, with XVS software, “as an aid for precisely locating anatomical structures in either open or percutaneous spinal procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be identified relative to CT imagery of the anatomy.” The predicate for the 510(k) submission was Medtronic plc’s Stealthstation S8 surgical navigation system

The system is comprised of a transparent near-eye-display headset, as well as the capabilities found in a traditional surgical navigation system. It plots the real-time positioning of surgical tools and superimposes a virtual trajectory over the patient’s CT imaging data. Using the headset, the navigation data is then projected in 3D onto the surgeon’s retina, enabling him or her to see both the patient’s anatomy and navigation guidance without looking away to a remote screen.

Source: https://www.bioworld.com/articles/432002-fda-greenlights-augmedics-ar-system-for-spinal-surgery
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