Proven Clinical & Business Impact

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

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 enable the evolution of existing hardware with AI capabilities, from medical image processing to custom imaging analytics. Designed to improve diagnostic and operational performance, our solutions are built to integrate seamlessly into clinical workflows.
Orthopedic Imaging Expertise
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We specialize in orthopedic imaging software that enhances surgical planning and decision-making. Our solutions support 2D to 3D transformation and streamline workflows to improve patient outcomes and clinical efficiency.

Together, we’ve developed the first FDA-cleared AI auto-segmentation tool converting DICOM images into precise 3D models.

What Powers Our Solutions

Core Technologies

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
Medical-focused mobile, edge, and cloud deployment
Integration capabilities designed to enhance existing workflows

Regulatory Excellence

FDA-cleared technology with proven compliance pathways
ISO13485 certified development processes
IEC62304 compliant software lifecycle
HIPAA and cybersecurity framework implementation

Your Roadmap, from Concept to FDA Clearance

Partnerships

Stronger Together: Partnerships That Make It Work

Great relationships don’t happen by chance, they’re built on trust, innovation, and seamless collaboration. We work side by side with our partners to accelerate digital transformation and create meaningful connections that last.

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