Proven Business Impact*

4x faster surgical planning with AI-powered automation
90% reduction in required support for segmentation
85%+ customer planning engagement
Efficient FDA regulatory pathways
Expedited time-to-market
Reduced time-to-market
New revenue streams with intelligent software
Differentiated devices with integrated AI innovations
Intelligence and data strategy for existing device portfolio

*Metrics taken from our flagship product developed for Shoulder Innovations.

Our Core Solutions

SaMD & FDA Compliance
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We help healthcare companies bring Software as a Medical Device (SaMD) to market. From concept to submission, we guide you through FDA clearance and global standards to ensure safe, compliant, and high-performing products.
AI-Powered Device Enhancement
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We transform your role from hardware supplier to a solutions partner, enabling existing device portfolios and building engaging software with advanced AI capabilities. From medical image processing to custom imaging analytics, our solutions elevate client relationships by delivering enhanced diagnostic and operational performance that integrates seamlessly into clinical workflows.
Orthopedic Device Expertise
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We specialize in orthopedic imaging software that enhances surgical planning, decision-making, navigation, and post-operative data collection. Our solutions support 2D to 3D transformations, streamline workflows, and integrate across user platforms to capture patient outcomes and deliver clinical efficiencies.

Together, we developed the first non-adaptive, AI-based orthopedic planning software under the newly established FDA guidelines for SaMD, leading innovation in this space.

What Powers Our Solutions

Core Technologies

Multi-modal medical image processing (MIPS) with AI-powered auto-segmentation
Unity-based 3D visualization and gaming engine integration
Software as a Medical Device (SaMD) architecture design
Medically-focused mobile, edge, and cloud deployment
Integration capabilities designed to enhance existing workflows

Regulatory Excellence

Proven experience with FDA regulatory pathways
ISO 13485-certified processes for medical devices
IEC 62304-compliant medical software lifecycle
HIPAA compliance and FDA-aligned cybersecurity frameworks

Your Roadmap, from Concept to FDA Clearance

Real Outcomes with Enabling Technologies

"Our partnership with ProVoyance™ bridges the gap between traditional medical device manufacturing and the software-driven future of healthcare. By embedding AI into clinical imaging workflows, we're delivering cutting-edge solutions that meet rigorous quality standards and help surgeons diagnose conditions, plan, and perform procedures with greater precision."

Claudio González
CTO & Executive Vice President at intive

Download our in-depth case study to see how we redefined surgical planning.

Download

Ready to Bring your Next Medical Device to Life?

Whether you’re starting from concept or upgrading your current product, we’ll help you get there faster, with less risk and greater impact. Fill out the form to connect with our experts and explore what we can build together.
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