Medivis, a company specializing in surgical intelligence, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Spine Navigation platform.

The platform uses augmented reality (AR) and artificial intelligence (AI) to provide holographic navigation in open and minimally invasive spine procedures. The company also launched Spine Navigation, making it available to hospitals and ambulatory surgical centers (ASCs).

It combines proprietary computer vision algorithms, AI segmentation, real-time data analysis, and advanced image processing for precise, context-aware insights. Lightweight AR hardware lets surgeons visualize critical info with comfort while operating. Hand tracking and voice commands offer control of the environment, removing attention-shift from the operative field.

The workstation has a minimal footprint and intuitive instrumentation, Medivis said. This allows the technology to integrate with spinal hardware and imaging systems from major vendors.

“Surgery is entering a new era of advanced computing that enhances precision, speed, and efficiency in the operating room,” said Dr. Christopher Morley, President of Medivis. “This is a pivotal moment in medicine, and we are thrilled to deliver a solution that will elevate patient care to new heights.”

“At Medivis, we envision a future where surgical navigation transcends boundaries by integrating imaging data with the operative field,” added Dr. Osamah Choudhry, CEO of Medivis. “With our recent FDA clearance for Spine Navigation, we are thrilled to equip surgeons with breakthrough technology to visually transform spine surgery and empower them with intuitive image guidance.”