Bradley Merrill Thompson, Member of the Firm, co-presents a webinar, "Artificial Intelligence and Machine Learning: Making Medical Devices Smarter," hosted by Tech Briefs.

Artificial intelligence (AI) and machine learning (ML) technologies are enabling medical devices to provide important insights to clinicians as they gather data generated during healthcare delivery. The U.S. Food and Drug Administration (FDA) has identified earlier disease detection, more accurate diagnosis, and development of personalized diagnostics and therapeutics as opportunities for high-value applications.

Early detection can be a game changer for diseases such as cancer or Alzheimer’s, enabling patients to receive life-saving therapies sooner, but other applications such as interpreting MRI images or improving medication adherence are also benefiting from AI and ML. This 60-minute webinar from the editors of Medical Design Briefs reviews the pathway to integrating this technology successfully.

In this webinar, attendees get:

  • A process overview of the total product lifecycle approach for ML and an overview of pre-market assurance of safety and effectiveness.
  • Process details of good ML practices; dataset selection and management; model training, tuning and evaluation; and addressing overfitting in ML models.
  • Clarity on which AI uses the FDA regulates: Multiple surveys indicate up to a quarter of companies do not know whether AI they use in medicine is FDA regulated.
  • An understanding of FDA expectations on bias and transparency: These are unique and evolving requirements for all uses of AI, and FDA is honing its approach to regulating these aspects.
  • An understanding of the technical considerations of bias, inclusion, and open-data sharing in the use of AI/ML in medical devices.
  • An explanation of the double-edged sword of AI and ML in medical devices as it relates to healthcare consumerism.
  • Details to make AI explainable: Where technical and data standards can have significant impact on driving stakeholder (patient, physician, regulatory, etc.) trust in the use of these applications.

For more information and to register, please visit

Event Detail

August 25, 2022
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