#USA #New York #Augmented Reality #FDA Clearance #Medivis

Medivis Sets New Standards in Neurosurgery with FDA Clearance

Medivis Inc., a groundbreaking company in the field of surgical intelligence, announced a major milestone in its innovative journey by receiving FDA 510(k) clearance for its Cranial Navigation platform. This achievement crowns Medivis as the pioneer in harmonizing augmented reality (AR) technology with cranial neurosurgery, thereby enabling a new era in surgical guidance.

The Significance of this Clearance

The approval signifies the world's first AR system cleared specifically for intraoperative guidance in neurosurgical procedures. This marks Medivis' second significant FDA clearance in a year, following the introduction of their Spine Navigation platform.

By adopting AR technology, the Medivis platform offers surgeons a spatially accurate depiction of patient imaging dynamically integrated within the surgical field. This advancement enhances the visibility of critical anatomy and planned trajectories, providing real-time guidance that elevates decision-making speed and confidence during complex cranial surgeries, all while minimizing interruptions to the workflow.

The portable nature of the platform allows for effective image guidance in locations where conventional systems typically falter, most notably in intensive care units (ICUs). Thus, it extends the reach of image-guided precision across various clinical settings, improving surgical outcomes.

Addressing a Critical Need

In neurosurgical settings, external ventricular drains (EVDs) face misplacement rates as high as 30%, resulting in repeated attempts, potential patient harm, and delays in critical care. Early clinical observations suggest that the Medivis system can significantly reduce such misplacements, thereby enhancing patient safety and expediting crucial interventions. This capability aims to uplift the standards of care within the realm of neurosurgery.

Voices from the Vanguard

Dr. Osamah Choudhry, CEO and co-founder of Medivis, remarked, “For the first time, neurosurgeons can perform cranial procedures using augmented reality. This merger of digital and physical realms offers high-accuracy guidance that will revolutionize the surgical landscape.” He further emphasized the importance of this clearance, not only for Medivis but for the entire neurosurgical community as it allows unparalleled precision directly at the bedside within ICUs.

Dr. Christopher Morley, co-founder and President of Medivis, acknowledged the collaborative effort with the FDA in making this technological leap possible. He affirmed that this achievement underlines Medivis' commitment to enhance surgical intelligence and sets the foundation for extensive deployment of AR guidance in various clinical environments, from operating rooms to surgical centers worldwide.

Unmatched Features of the Cranial Navigation Platform

The Medivis Cranial Navigation platform encapsulates numerous features that address critical needs in surgical environments:

1. Surgical Intelligence

The technology employs proprietary computer vision, segmentation capabilities, real-time data analysis, and sophisticated image processing, delivering context-aware guidance throughout surgical routines.

2. Ergonomic Design

Lightweight hardware allows key information to remain in the line of sight of surgeons, reducing the chances of distraction and facilitating an unhindered focus on the operative field.

3. Integration into Diverse Environments

The platform is adept at streamlining data-driven decision-making, empowering clinicians in both routine and challenging situations, including on-site procedures in ICUs where traditional systems have limitations.

Medivis, with its FDA clearances for both Cranial Navigation and Spine Navigation, has positioned itself as a leader in AR technology adoption across multiple medical specialties. This initiative aims to establish a new standard in surgical procedures worldwide, allowing surgical intelligence to enhance patient outcomes across various settings.

About Medivis

Medivis is a pioneering surgical intelligence firm committed to revolutionizing surgical navigation through artificial intelligence and augmented reality. For more information, visit www.medivis.com.