Medivis Receives FDA 510(k) Clearance for Spine Navigation and Announces Commercial Launch in the United States

NEW YORK, April 2, 2025 /PRNewswire/ – Medivis Inc., a pioneer in surgical intelligence, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking Spine Navigation platform. This milestone marks a significant advancement in surgical technology, utilizing AR and AI to empower surgeons with holographic navigation across open and minimally invasive spine procedures. Alongside the FDA clearance, Medivis is announcing the commercial launch of Spine Navigation, making it available to hospitals and ambulatory surgical centers nationwide.

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

"At Medivis, we envision a future where surgical navigation transcends boundaries by integrating imaging data with the operative field. 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," added Dr. Osamah Choudhry, CEO of Medivis. 

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Medivis’ Spine Navigation platform is applicable across neurosurgery and orthopedic surgery. Its key strengths include: 

• Surgical Intelligence: Combining proprietary computer vision algorithms, AI segmentation, real-time data analysis and advanced image processing to deliver precise, context-aware insights throughout the surgical workflow. 
• Ergonomic Freedom: Lightweight AR hardware allows surgeons to visualize critical information with unmatched comfort while operating. Hand tracking and voice commands grant complete control of the environment, eliminating attention-shift away from the operative field. 
• Seamless Integration: Minimal-footprint workstation paired with intuitive instrumentation allows Medivis’ technology to integrate with spinal hardware and imaging systems across major commercial vendors. It is built for easy deployment in operating rooms, including in ambulatory surgical centers. 

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Spine Navigation is the latest addition to the company's portfolio of AI-powered surgical solutions, which are designed to transform the operating room and enhance surgical precision across a range of specialties.

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About Medivis 

Medivis is a leading surgical intelligence company dedicated to pioneering the future of surgical navigation with artificial intelligence and augmented reality. To learn more, visit www.medivis.com.