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What does the FDA jurisdiction for LDTs mean for the labs? Do they need to worry? How do they need to change the way they operate?

In this episode, I talk with Dr. Thomas Nifong, a clinical pathologist and VP of CDX operations at Acrovan Therapeutics, about the recent FDA ruling on laboratory-developed tests (LDTs) issued on May 6th, 2024. We discuss the implications of considering LDTs as medical devices, requiring regulation, and explore the authority of FDA versus CLIA. The conversation also covers historical contexts, practical implications of regulatory changes, and the roles of organizations like CAP, ACLA, and AMP in legal challenges against the FDA. We dive into the differences in requirements between CLIA and FDA, New York's alternative approval route, and potential impacts on lab operations and compliance. Join us for an insightful conversation filled with essential information for those in the field of molecular pathology.

00:00 Introduction and Special Guest Announcement
00:24 FDA's New Rule on Laboratory Developed Tests (LDTs)
01:58 Recording the Podcast: A Casual Lunch Conversation
03:47 Understanding FDA's Authority Over Medical Devices
08:07 Disputes and Legal Challenges
12:03 Practical Implications and Industry Reactions
12:47 Understanding FDA's Focus: Safety and Efficacy
14:11 The Role of CMS and Medical Necessity
14:48 Congressional Involvement and Legal Authority
16:06 Impact on Labs and Future LDTs
18:33 Quality Systems and Compliance
20:16 Modifications and Software Updates
21:16 Conclusion and Next Steps

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In this episode, I had a fascinating conversation with Candice Chu, DVM, PhD, DACVP, about how artificial intelligence (AI) is reshaping veterinary diagnostics and education. Candice, a clinical pathologist and educator at Texas A&M, is using AI tools like ChatGPT to improve efficiency in clinical workflows and academic processes. We explored the practical applications of AI, ethical concerns, and its future impact on veterinary medicine.

Key Topics Discussed:

• [00:00:00] Introduction to AI in Veterinary Education and Diagnostics
  I ask Candice how AI is changing veterinary education and diagnostics, and she explains how AI is boosting efficiency in both areas.
• [00:01:00] Candice’s Journey in Veterinary Medicine
  Candice shares her journey from Taiwan to the U.S., her career in veterinary pathology, and becoming an educator at Texas A&M.
• [00:05:00] Custom GPT Model for Clinical Pathology
  Candice describes the development of her custom GPT model for clinical pathology and its role in improving diagnostic efficiency.
• [00:10:00] AI Tools for Academic and Clinical Efficiency
  We talk about how AI tools reduce repetitive tasks, giving professionals more time for critical thinking and decision-making.
• [00:14:30] Ethical Concerns When Using AI in Veterinary Medicine
  Candice emphasizes the ethical responsibility of using AI, highlighting the importance of human judgment in AI-assisted diagnostics.
• [00:20:00] How Veterinary Students Can Leverage AI
  Candice shares tips on how students can use AI to enhance learning, from simplifying research to generating case questions.
• [00:29:00] AI’s Role in Academic Writing and Veterinary Practice
  We discuss how AI tools streamline academic writing and research, and how AI will continue shaping veterinary practice in the future.
• [00:39:00] Critical Thinking and AI in Veterinary Medicine
  Candice and I conclude by discussing how critical thinking and professional responsibility are essential when using AI tools.

Candice highlighted the transformative role AI can play in both veterinary education and diagnostics, improving efficiency while requiring responsible use. While AI tools like ChatGPT offer many benefits, the human element—our critical thinking and judgment—remains crucial in ensuring accurate results and ethical practices.

This episode provides practical insights on how veterinary professionals, educators, and students can harness AI to streamline workflows and improve diagnostic accuracy. Be sure to listen to the full conversation for actionable tips on integrating AI into your practice!

EPISODE RESOURCES:

• About Dr. Candice Chu (Including her social media and achievements)
• Candice's Paper
• Undermind AI
• Youtube Episode of this Episode

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In this episode, Dr. Richard Fox shares how AI is transforming veterinary diagnostics. From his early career to the world of AI, Dr. Fox offers practical insights into the challenges, opportunities, and innovations that AI brings to pathology. Tune in to learn how AI is enhancing workflow efficiency, diagnostic precision, and the future direction of veterinary pathology.

[00:00] Introduction – Introduction to Dr. Richard Fox and his expertise in veterinary pathology and AI.

[03:00] Dr. Fox’s Career Journey – His shift from veterinary practice to pathology and AI.

[08:00] Entering the AI Space – How Dr. Fox became involved in AI, including his work with Aiforia.

[15:00] AI in Diagnostics – AI’s impact on diagnostic workflows and speeding up tasks.

[22:00] Quality Control in AI Models – Ensuring AI model accuracy and the importance of data consistency.

[28:00] AI Model Validation Challenges – Overcoming issues with model validation and retraining.

[35:00] Integrating AI into Workflows – How AI fits into veterinary pathology workflows and practical considerations.

[40:00] Future of AI in Pathology – Predictions on the future trends in AI and on-premises diagnostics.

[50:00] Common Questions About AI – Addressing concerns like AI replacing pathologists and optimizing workflows.

[58:00] Conclusion – Key takeaways and how to get started with AI in veterinary diagnostics.

The Episodes Resources:
Contact Aiforia
Richard Fox's LinkedIn Profile
Richard Fox's Email

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Become a Digital Pathology Trailblazer get the "Digital Pathology 101" FREE E-book and join us!