Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform.
The company said clearance makes Cranial Navigation the world’s first AR system cleared for intraoperative guidance in cranial neurosurgery. It marks the company’s second major FDA clearance this year, following the launch of its Spine Navigation platform.
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New York-based Medivis’ FDA milestones go as far back as 2019, when the agency cleared its SurgicalAR platform. At that time, the company also touted strategic partnerships with Verizon and Microsoft.
The Cranial Navigation platform uses AR to spatially map patient imaging within the operative field. Medivis said it gives surgeons a clear, real-time view of critical anatomy and planned trajectories. It designed the approach to support faster, more confident decision-making during cranial procedures. The platform can also minimize workflow disruption and reduce dependence on external monitors.
Medivis said its platform’s portable design also enables reliable image guidance in settings where conventional systems fail. That includes the intensive care unit (ICU). This extends image-guided precision to a wider range of clinical environments, helping to reduce misplacements, improve patient safety, accelerate life-saving interventions and raise the standard of care in neurosurgery.
Cranial Navigation combines proprietary computer vision, segmentation, real-time data analysis and advanced image processing. Lightweight AR hardware helps keep critical information in the surgeon’s line of sight and reduces attention shifts away from the operative field. The platform streamlines data-driven decision-making in routine settings and previously inaccessible environments, too, Medivis says.
“For the first time, neurosurgeons can perform cranial procedures using augmented reality – merging the digital and physical worlds with high-accuracy guidance,” said Dr. Osamah Choudhry, CEO and co-founder of Medivis. “This is a profound milestone not only for Medivis, but for the entire field of neurosurgery. With this clearance, we’re bringing image-guided navigation to the ICU, where it hasn’t been possible before, giving clinicians greater precision at the bedside and helping support safer care for patients, while paving the way for full integration into operating rooms.”
