Description

Summary

This discussion provides a high-level overview of the current state of artificial intelligence (AI) in in vitro diagnostics (IVDs).

The conversation between Director of IVD Intelligence and Innovation, Margot Borgel, and Principal Regulatory Scientist, Bethany Chung, Ph.D., RAC, covers several aspects of AI in IVDs, including its use in diagnosis and predictive algorithms, aiding in the diagnostic workflow, supporting performance testing, and assisting in regulatory efforts. The importance of considering the global view of AI – including public opinion, diversity, privacy, and cybersecurity – is also highlighted.

Takeaways

• AI is rapidly growing in the field of IVDs, with a significant increase in the number of AI-based medical devices being approved by regulatory authorities.
• AI is used in IVDs for diagnosis and predictive algorithms, aiding in the diagnostic workflow, supporting performance testing, and assisting in regulatory efforts.
• Regulatory workflows can be enhanced with AI, including software that aids in literature reviews, aligns regulatory documents, and assists with PMS analysis.
• Considering the global view of AI in IVDs is crucial, including addressing bias, ensuring diversity in training data, complying with privacy laws, and prioritizing cybersecurity.

Chapters (Approximate)

• 00:00 Introduction and Current State of AI in IVDs
• 05:20 AI in IVDs: Diagnosis and Predictive Algorithms
• 12:18 AI in IVDs: Aiding in the Diagnostic Workflow
• 15:48 AI in IVDs: Supporting Performance Testing
• 24:45 AI in IVDs: Supporting Regulatory Efforts
• 30:23 Global View of AI in IVDs

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