MEDICAL DEVICES//
Verification Across the Device Lifecycle
XR Vision enables medical device manufacturers to verify sealed kits prior to implantation and confirm device presence and configuration after implantation — using routine X-ray imaging, without workflow disruption or regulatory friction.
Challenge
Medical device manufacturers lose visibility once products leave the factory.
Kits and trays are assembled once and assumed correct.
Component issues are often discovered late — sometimes only after implantation.
Post-market surveillance relies heavily on passive reporting and incomplete signals.
As a result:
- Investigations are slow and resource-intensive
- Recalls tend to be broad rather than targeted
- Existing clinical imaging data remains largely unused
These gaps increase operational risk, regulatory burden, and downstream cost.
The XR Vision Approach
XR Vision is a radiographic verification platform designed for medical device manufacturers operating in real-world clinical environments.
The platform enables:
- Pre-implantation verification of sealed kits and components
- Post-implantation device confirmation using routine clinical imaging
- Structured use of follow-up imaging for post-market surveillance
All without introducing new clinical workflows, procedures, or regulatory requirements.
What XR Vision Enables
Began with three highest-volume trays; expanded to long-tail SKUs using fast model cloning and controlled reference captures. Integrated with WMS for unit-level trace.
Why Manufacturers Use XR Vision
Manufacturers adopt XR Vision to:
- Reduce risk associated with kit variability and assembly assumptions
- Maintain visibility after devices leave the factory
- Strengthen post-market surveillance without initiating new trials
- Leverage imaging data that already exists
- Reduce the scope, cost, and disruption of investigations and recalls
XR Vision supports earlier insight — not additional burden.
Designed for Real-World Deployment
- Operates with existing X-ray imaging systems
- Non-diagnostic and non-interventional
- No changes to clinician workflow
- Does not require FDA clearance or clinical trials
- Configured per manufacturer and product line
The platform integrates into existing environments rather than asking them to change.
OPTIONAL: Radiopaque Marker Technology (LUM)
For manufacturers requiring deterministic radiographic identification, Mineral City AI also offers LUM, a proprietary radiopaque marker technology that can be embedded into medical devices.
LUM enhances traceability and recall precision, but is not required to deploy XR Vision.
Manufacturers may adopt XR Vision with or without embedded markers, depending on product and risk profile.
Lifecycle Coverage
Before Implantation
- Verification of sealed kits and components
- Detection of missing, incorrect, or swapped parts
After Implantation
- Structured use of real-world imaging for post-market surveillance
- Earlier detection of potential failure signals
- Support for narrower, evidence-based recalls
Getting Started
XR Vision is licensed as an enterprise platform and configured to each manufacturer’s products and workflows.
Manufacturers use XR Vision to reduce post-market risk, operational friction, and the cost of downstream remediation.
Talk to us about a pilot.