Accelerate Your Enabling Technology with a Proven Digital Surgery Core
Adopt our regulatory-compliant AI planning and navigation launch engines — licensable platform stacks for OEM medical device manufacturers.
We own the First FDA-Cleared AI-Powered Surgical Planning System in Orthopaedics
In 2021 ProVoyance received FDA clearance as the FIRST AI-enabled preoperative planning platform in Orthopaedics. With our experience and deep expertise in navigating the AI/ML regulatory framework, our team is committed to helping our OEM partners reduce risk and accelerate timelines to clearance.
The ProVoyance Core Stack
Licensable, FDA-cleared platform components designed for rapid OEM integration.
FDA-Ready AI Segmentation
Automated DICOM-to-3D transformation with established regulatory precedent. License our proven AI models to avoid multi-month validation cycles.
Configurable Planning Tools
Customize planning workflows within a validated framework. Your implant catalog, your brand — accelerated by our regulatory-vetted core.
Plan-to-Navigation Pipeline
Seamless integration across surgical modalities. Transform preoperative plans into real-time guidance- whether through navigation systems, robotic platforms, or augmented reality visualization.
Why License versus Build?
The Strategic Calculation for OEMs
License the Core. Own the Product.
We build your engine. You focus on your device differentiation.
From Image to Execution: The Complete Digital Surgery Pipeline
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Medical Imaging (DICOM)
Standard DICOM input from CT or MRI systems
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Cleared DICOM Transformation Engine
FDA-cleared image processing and quality validation
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FDA-Cleared AI Segmentation
Automated anatomical segmentation with established regulatory precedent
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Planning Framework
Customizable surgical planning tools within validated framework
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Navigation Integration (Optional)
Seamless plan-to-navigation pipeline via INS partnership
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Clinical & Technical Support Infrastructure
ISO 13485 QMS with post-market monitoring framework
Ready to Accelerate Your Digital Surgery Roadmap?
ProVoyance invites OEM partners to a strategic technical deep dive. No obligation. Designed to assess strategic fit before capital commitment.