Vuze Medical's proprietary software-only guidance system received FDA 510(k) clearance.
The Vuze system is designed for spinal stabilization surgeries in outpatient settings, according to a Jan. 18 news release. It does not use sensors or cameras, instead relying on 2D X-rays. The first patient cases were completed in Israel, and the company expects a U.S. debut in mid-2022.
"VUZE Medical was founded to address a technology gap in guiding short-segment spinal interventions. We are aiming to preserve the advantages of common X-ray guidance while addressing its shortcomings," CEO David Tolkowsky said in the release. "Rising cost pressures and a growing aversion towards hospitalization in the age of COVID-19 are accelerating a shift of short-segment surgeries from inpatient to outpatient and from outpatient to ambulatory settings. In such settings, reliance on X-ray guidance is particularly high. We believe this will be the greatest opportunity for our system."