US-based medical technology company Medivis has received the US Food and Drug Administration (FDA) 510(k) approval for its advanced Spine Navigation platform.
The Spine Navigation platform leverages augmented reality (AR) and artificial intelligence (AI) and can be used in both neurosurgery and orthopaedic surgery.
It provides surgeons with holographic navigation for both open and minimally invasive spine procedures.
The platform features surgical intelligence that combines proprietary computer vision algorithms, AI segmentation, real-time data analysis, and advanced image processing.
The elements work together to deliver precise, context-aware insights throughout the surgical workflow, enhancing the overall surgical experience.
With the FDA clearance, Medivis plans to commercially launch Spine Navigation for use in hospitals and ambulatory surgical centres across the US.
Medivis president Christopher Morley said: “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.”
Spine Navigation is the latest addition to Medivis’ portfolio of AI-powered surgical solutions, modernising the operating room and improving surgical precision across various specialities.
The platform’s lightweight AR hardware allows surgeons to visualise critical information comfortably during operations.
The system supports hand tracking and voice commands, enabling surgeons to maintain focus on the operative field without distraction.
Its minimal-footprint workstation and intuitive instrumentation allow the technology to work with spinal hardware and imaging systems from major commercial vendors.
The system offers significant value to patients, surgeons, and institutions.
For patients, the platform promises potential improved outcomes, personalised surgical plans, educational breakthroughs, and potential radiation reduction.
Surgeons can benefit from transformative ergonomics, real-time guidance, submillimetre accuracy, and fast clinical workflows.
Institutions can gain from the system’s small footprint, reimbursable technology, cost-effectiveness compared to legacy systems, and secure on-premises IT solutions.
Medivis CEO Osamah Choudhry said: “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.”
