Our AI-IVD Services:
Strategic AI Development:
Craft AI algorithms for cancer detection.
- Develop comprehensive protocols aligned with evolving FDA guidance for AI-enabled device software functions.
- Create customized templates for informed consent, data capture, and specimen handling protocols.
Cohort-Driven AI Training Sets:
Access diverse patient cohorts for AI training.
Biomarker-Integrated Data Ecosystems:
Integrate patient data with biomarkers.
- Manage the collection of diverse patient data, including various disease states and risk profiles.
- Seamlessly integrate electronic health records (EHR) with customized electronic Case Report Forms (eCRFs).
Biospecimen-to-Algorithm Bridging:
Connect biospecimens to AI pipelines.
End-to-End AI Data Optimization:
Streamline data flow from patients to labs.
- Implement strict validation methods for data streams and process workflows.
- Ensure thorough data curation, standardization, and quality assurance to reduce bias and improve ML training effectiveness.
Regulatory Navigation and Compliance:
Ensure compliance with evolving AI guidelines.
- Provide strategic guidance through the evolving regulatory framework for AI-powered medical devices.
- Ensure compliance with FDA guidelines for AI/ML-based Software as a Medical Device (SaMD).
Why Choose Us:
Proven Expertise:
Collaborative history with industry leaders in liquid biopsy and AI diagnostics.
Comprehensive Data Management:
From protocol design to ML-ready data delivery.
Regulatory Insight:
Deep understanding of FDA requirements for AI-enabled diagnostic platforms.
Quality-Focused Approach:
Rigorous methods ensuring high-quality, unbiased data for AI model training.
Enhance your AI-powered IVD project with AbilityDx:
Our integrated approach ensures your data architecture and processes meet the highest standards for AI development in advanced diagnostics.
The AbilityDx Advantage
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Ready to ignite your AI-Powered IVD?
Partner with us to transform your biospecimen challenges into opportunities. Whether you need strategic insights or end-to-end solutions, we’re here to elevate your program.
Ready to ignite your AI-Powered IVD? Let’s turn your vision into algorithms that redefine diagnostics. Connect with us to accelerate your AI journey.
Let’s turn your vision into algorithms that redefine diagnostics. Connect with us to accelerate your AI journey.
