The AI Revolution – Webinar Recording/Transcript

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The AI Revolution: What You Must Know About Medical Imaging Regulation

AI is changing the face of image analysis — allowing complex patterns in medical images to be identified to a greater degree than ever before. Specific conditions can be identified… quantified… independently diagnosed… or ruled out entirely. With this comes the possibility of over-reliance on technology — potentially reducing vigilance with standard of care.

How will the FDA keep pace with the evolving nature of these technologies while still ensuring that their safety and effectiveness are maintained? While there are still many issues the agency must work through, you need an understanding now of the FDA’s approaches to AI-based image analysis.

As both a physician and a lawyer, John J. Smith, M.D., J.D, a partner at Hogan Lovells, is uniquely suited to explain what you need to know about the FDA’s AI regulation in this 90-minute presentation.

Presentation Takeaways:

  • How FDA views AI within its medical device regulatory paradigm
  • The different types of computer-assisted image analysis recognized by FDA
  • The data that FDA expects to support AI-based CAD applications
  • How FDA views post-market changes to CAD algorithms

You will understand the new regulatory framework FDA is developing so that you can determine how to best incorporate AI into your devices and software.

  • Executive Management
  • Regulatory Professionals in Medical Image Analysis
  • Development Professionals in Medical Image Analysis

John J. Smith, M.D., J.D, a partner at Hogan Lovells, is both a physician and a lawyer. He combines clinical and regulatory experience relating to the FDA with a practical approach to addressing the FDA regulatory issues facing his clients. Dr. Smith places a particular focus on bringing device-based technologies to market. A board-certified diagnostic radiologist and former associate professor of radiology at Harvard Medical School, he joined the Hogan Lovells Medical Device Group in 2005. Since then, Dr. Smith has assisted clients in a range of FDA premarket submissions, including 510(k) notices, de novo reclassification petitions, humanitarian device exemption applications and premarket approval applications, including the advisory panel process.