SurgicalAR

by MEDIVIS  · Based in United States → — A New Standard of Surgical Intelligence.
General Surgery Neurosurgery Orthopedics

Contact for pricing
Regulatory Status Disclosed

Overview

SurgicalAR by MEDIVIS is an advanced augmented reality (AR) and artificial intelligence (AI) platform designed to revolutionize surgical planning and navigation. It transforms complex 2D medical imaging data, such as MRIs and CTs, into high-fidelity 3D holographic visualizations that can be superimposed directly onto the patient’s anatomy in real-time during an operation. This immersive approach enhances a surgeon’s visuospatial understanding, allowing for improved precision, faster decision-making, and reduced errors in complex procedures.

The platform integrates seamlessly with existing hospital Picture Archiving and Communication Systems (PACS) and offers a minimal footprint, making it portable for use in operating rooms, ICUs, and clinics. SurgicalAR is utilized across various specialties, including neurosurgery and orthopedics, to guide procedures like brain tumor removal, aneurysm treatment, and spine navigation.

Key functionalities include AI-based automatic registration and segmentation, photorealistic renderings, infrared instrument tracking, and spatial interactions via hands and voice. It supports multi-method registration techniques and offers integrated ultrasound visualization.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • 3D holographic rendering of patient anatomy
  • Real-time image overlay and custom virtual monitors
  • Seamless integration with existing PACS systems
  • AI-based Automatic Registration for speed and accuracy
  • Real-time Automatic Segmentation and photorealistic renderings
  • Infrared instrument tracking by specialty
  • Spatial interactions with hands and voice
  • Precise multi-method registration (Surface Digitization, Trace Collection, Landmark Collection)
  • Ultrasound Visualization integration (Clarius probes, wired probes)
  • STL/OBJ import for segmented models

Use Cases

  • Preoperative surgical planning
  • Intraoperative surgical navigation and guidance
  • Complex brain tumor removal and aneurysm procedures
  • Open and minimally invasive spine surgery
  • Cranial navigation (EVDs, subdural evacuations, craniotomies)
  • Prostate biopsies and tumor ablations (research only)

Details

Category Surgical AI
Pricing Contact for pricing — Tailored to each deployment; continuous updates, fraction of cost compared to traditional systems.
DeploymentOn-premise IT; Medivis PRO for operating rooms, Medivis CORE for ICUs & clinics, Medivis VIEWER for office use.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

SurgicalAR received U.S. FDA 510(k) clearance (K190764) on May 13, 2019, for clinical use in the operating room. It also has FDA clearance for Spine Navigation and Cranial Navigation.

Integrations
EHR Not specified
Specialties General Surgery, Neurosurgery, Orthopedics

Ratings & Reviews

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Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

BioWorld
Medivis Lands $20M for AR-Guided Surgical Navigation Platform
Medivis Inc. secured $20 million in Series A funding to advance its 3D holographic clinical visualization system, SurgicalAR, which uses augmented reality, AI, and computer vision to enhance surgical accuracy and precision. The funds will be used for FDA clearances in new specialties, engineering scale-up, and global commercialization.
2023-06
TIME
Medivis SurgicalAR: The 200 Best Inventions of 2023
TIME recognized Medivis's SurgicalAR platform as one of the best inventions of 2023 for its ability to superimpose patient data onto the body during surgery using an AR headset, providing visual guidance for complex procedures and reducing errors.
2023-10
Veterans Affairs
AI Revolutionizes Surgical Precision And Patient Outcomes At Tampa VA
The Tampa VA, in collaboration with the VHA Innovation Ecosystem, is utilizing Medivis SurgicalAR to transform 2D imaging into 3D holographic visualizations for enhanced preoperative planning and intraoperative guidance, aiming to improve surgical precision and reduce errors for veterans.
2025-03
E Magazine
Application of Augmented Reality in Modern Healthcare: Revolutionizing Patient Care and Medical Practices
This article highlights Medivis' SurgicalAR as a key example of augmented reality in surgery, enabling surgeons to overlay 3D anatomical models onto patients for improved precision, reduced errors, and shorter operating times in various procedures like orthopedic and brain surgery.
2025-09
PMC (Peer-Reviewed Medical Journal)
Intraoperative use of mixed reality (MR) in humans across surgical disciplines: a major review
A comprehensive review of mixed reality in surgery identifies SurgicalAR (Medivis) as a fully integrated MR-SN platform, noting its sub-millimeter positional accuracy in bench testing and its application across various surgical specialties.
2025-12
SpringerLink (Peer-Reviewed Medical Journal)
Augmented reality in cranial surgery: Surgical planning and maximal safety in resection of brain tumors via head-mount
This study details the workflow of using Medivis' SurgicalAR software with AR head-mounted displays for surgical planning and intraoperative guidance in brain tumor resections, transforming 2D CT and MR images into interactive 3D holograms for enhanced precision.
2025-03
PR Newswire
Medivis Wins FDA Clearance for Breakthrough Augmented Reality Surgical System
Medivis announced that its SurgicalAR platform received 510(k) clearance from the U.S. FDA for clinical use in the operating room, enabling immediate commercialization of the technology that integrates AR, AI, and computer vision to improve surgical visualization.
2019-05
FDA
K190764 - 510(k) Premarket Notification
This regulatory document from the FDA confirms the 510(k) premarket notification for Medivis, Inc.'s SurgicalAR, classified as a radiological image processing system (Product Code LLZ), indicating its clearance for medical image display and manipulation.
2019-05

Videos

Product demos, reviews, and walkthroughs for SurgicalAR.

View all on YouTube

Frequently Asked Questions

SurgicalAR transforms 2D medical imaging, such as CT and MRI scans, into high-fidelity 3D holographic visualizations that can be superimposed directly onto the patient's body during procedures. This integration allows surgeons to visualize internal anatomy in real-time within their field of view, enhancing surgical planning and intraoperative guidance, and potentially reducing complications. The platform also incorporates AI for features like automatic and interactive segmentations of medical images and dynamic control of visualizations through natural language.
SurgicalAR has received 510(k) clearance for clinical use in the operating room by the U.S. Food and Drug Administration (FDA) and is also CE-Marked and KSFDA-Cleared. Medivis, the developer of SurgicalAR, states that the platform uses on-premise IT with certified gold-standard security, and patient data never leaves the hospital firewall, ensuring a secure and HIPAA-compliant PACS integration without storing Protected Health Information (PHI) in the cloud.
Alternatives in augmented reality or AI-assisted surgery include systems like Augmedics xvision spine system, Novarad VisAR, Neo Medical's ADVISE platform, and Surglasses Caduceus S. SurgicalAR differentiates itself by integrating augmented reality, artificial intelligence, and computer vision to advance surgical visualization, aiming to decrease complications and improve patient outcomes by providing immersive 3D holographic overlays directly onto the patient.
While specific pricing for SurgicalAR is not explicitly detailed in the search results, augmented reality surgical systems generally represent a considerable investment. The company mentions 'continuous updates, fraction of cost' in comparison to 'expensive upfront investment' for older, bulky systems, suggesting a potential subscription or service model for ongoing access and updates. However, precise figures for initial investment, subscriptions, or maintenance are not publicly available in the provided snippets.
General limitations of AR in surgery include challenges with maintaining accurate registration due to patient or organ movement, potential visual discomfort from headsets during long surgeries, and the need for improved battery life. SurgicalAR addresses some of these with precise multi-method registration and aims to reduce cognitive load through intuitive interfaces and hands-free operation. Ethical considerations also include ensuring proper informed consent regarding the technology's use and addressing potential long-term impacts on the human workforce.
SurgicalAR is supported by clinical research, with Medivis providing access to studies on its website, including a Memorial Sloan Kettering Cancer Center study on ovarian cancer cytoreduction planning. The technology has been noted to enhance preoperative planning and intraoperative guidance, with AR-guided navigation systems showing benefits in improved ergonomics and visualization, and reduced surgical time and blood loss in some studies. A recent randomized controlled trial (RIDERS trial) demonstrated that AR-guided biopsies achieved a significantly higher lesion positivity rate and reduced positive surgical margin rates in robotic prostatectomy.
SurgicalAR prioritizes data security by utilizing an on-premise IT deployment with certified gold-standard security, ensuring patient data never leaves the hospital firewall. This approach facilitates a secure and HIPAA-compliant PACS integration, where patient information is accessed and rendered into 3D holograms without storing Protected Health Information (PHI) in the cloud.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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