Live! #88 – Electric Brains & Regulatory Pains: Accelerate Neurology Innovation, Slash Risk, & Win Approval

This panel was recorded June 26, 2025.⁠⁠⁠⁠ We hope you'll join us live in the future to ask your own questions and participate in the attendee chat! See similar events on demand and read other free MedTech resources at RQMplus.com.

Summary

Hear leading neurology innovators discuss how to navigate complex regulatory pathways, accelerate approvals, and reduce risk in bringing groundbreaking neurological devices to market.

LinkedIn panelist and moderator profiles 

• 🧠 Allison Komiyama, Ph.D., RAC – Vice President, MedTech Innovation
• 🧠 Bethany Knorr Chung, Ph.D., RAC – Senior Manager, Technical
• 🧠 Christine Santagate, RAC – Vice President, Lab Services
• 🧠 Jon Gimbel, Ph.D. – Vice President, Technical (moderator)

 

Timestamps

00:00 Introduction to Neurology Innovation and Regulatory Challenges
02:57 Panelist Introductions and Their Expertise
05:54 Exciting Developments in Neurological Devices
08:48 The Role of AI and Machine Learning in Neurology
11:58 Testing and Safety Considerations for Neurological Devices
14:51 Regulatory Framework and Challenges for Neurological Devices
19:00 Ethical Considerations in Neurological Device Development
35:20 Ethical Considerations in Medical Devices
36:47 Patient Information and Healthcare Provider Communication
39:03 Regulatory Perspectives on Device Usability
42:57 Challenges in Medical Device Studies
46:58 Real World Evidence in Medical Device Evaluation
51:10 Navigating Regulatory Pathways: FDA vs. EU
55:55 The Future of Medical Device Regulation
01:01:30 Exciting Innovations in Neurological Treatments
01:06:49 Concluding Thoughts on Clinical Trials and Future Directions

More neurology resources from RQM+

• Wires to AI: The Regulatory Landscape of Neurological Devices
• Artificial Neural Network Supporting Biological Neural Networks
• What is the Benefit of Seeing the Brain?

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