As artificial intelligence continues to revolutionize medical device development, the FDA's evolving regulatory framework presents both opportunities and challenges for manufacturers. The recently released guidance on AI/ML-enabled medical devices introduces crucial...
AI Medical Devices: Your Comprehensive Guide to Development and Documentation
The integration of artificial intelligence into medical devices represents a transformative shift in healthcare technology. Yet, for manufacturers and developers, the path from concept to commercialization demands meticulous attention to regulatory requirements and...
Navigating FDA’s Latest Guidance Updates for AI-Enabled Medical Devices: A Marketing Submission Guide
As artificial intelligence transforms healthcare innovation, the FDA continues to evolve its regulatory framework for AI-enabled device software functions (AI-DSF). In 2024-2025, the agency released two crucial guidance documents that reshape the submission process...
Leveraging AI and ML in Medical Products – Part 3
Bob Bouthillier Director, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...
Leveraging AI and ML in Medical Products – Part 2
Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...
Leveraging AI and ML in Medical Products – Part 1
Bob BouthillierDirector, Electrical Engineering, Veranex In this three-part series, Bob Bouthillier discusses the state of artificial intelligence (AI) and machine learning (ML) today, its potential across a variety of applications, an analysis of challenges faced by...