Medivis Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cranial Navigation platform. This second major speciality clearance (the company gained authorization for Spine Navigation last year) is the first to be granted to an augmented reality (AR) system for intraoperative guidance in neurosurgery.

External ventricular drains (EVDs) currently are misplaced at rates reported as high as 20% to 40%, often leading to repeated passes, patient harm, and delayed critical care for some of the sickest hospitalized patients. By providing real-time, AR-guided visualization at the bedside, early validation shows Medivis can significantly reduce these misplacements—directly improving patient safety, accelerating life-saving interventions, and raising the standard of care across neurosurgery.

“This achievement reflects an extraordinary collaboration between our team and the FDA, whose leadership and shared commitment to elevating patient care made this innovation possible,” Medivis Co-Founder/President Dr. Christopher Morley said. “We appreciate the agency’s partnership, which helped ensure the highest standards of safety and efficacy. This milestone not only attests to our technology but also lays the foundation for broad deployment of AR navigation across ICUs, ORs, and surgical centers worldwide, advancing a future where surgical intelligence improves outcomes in every clinical setting.”

Its compact design, segmentation, real-time instrument tracking, and AR visualization make reliable navigation possible in settings where traditional systems have been too large or cumbersome—most notably the Intensive Care Unit (ICU)—bringing the potential benefits of image-guided surgery to a wide range of clinical environments and procedures. 

Medivis’ Cranial Navigation system sets a new standard in neurosurgery, delivering advanced capabilities that can support enhanced precision, safety, and efficiency:

• Direct Visualization and Guidance: Real-time 2D and 3D imaging data and instrument positions within the surgeon’s field of view, eliminating the need to look away toward external monitors. This can enhance spatial awareness and accuracy while supporting shorter operating times.
• Proprietary Computer Vision: Deep learning algorithms deliver high-fidelity anatomical mapping and segmentation, providing surgeons with detailed, patient-specific insights to inform every stage of the procedure.
• Seamless Integration Across Clinical Settings: Portable workstation and lightweight AR interface enable seamless integration into OR, ICU, and ambulatory surgical center (ASC) workflows, bringing advanced surgical navigation to previously inaccessible environments. 

“For the first time, neurosurgeons can perform cranial procedures within an augmented environment that merges the digital and physical worlds with high-accuracy performance,” Medivis Co-Founder/CEO Dr. Osamah Choudhry stated. “This is a 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 the OR.” 

With FDA clearance for cranial and spine navigation, Medivis is accelerating the adoption of augmented reality across critical care and surgery. Together, its AR systems can empower clinicians to deliver safer, faster, and more precise procedures across multiple specialties, paving the way for AR navigation to become standard in ICUs and operating rooms worldwide, according to the company. 

Medivis is a surgical intelligence company pioneering the future of surgical navigation with artificial intelligence and augmented reality.