<p><em>This panel was recorded June 26, 2025.⁠⁠⁠⁠ We hope you&#39;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 </em><a href="https://www.rqmplus.com/resources/" target="_blank" rel="noopener noreferer"><em>RQMplus.com</em></a><em>.</em></p><p><br></p><p><strong>Summary</strong></p><p>Hear leading neurology innovators discuss how to navigate complex regulatory pathways, accelerate approvals, and reduce risk in bringing groundbreaking neurological devices to market.</p><p><br></p><p><strong>LinkedIn panelist and moderator profiles </strong></p><ul><li>🧠 <a href="https://www.linkedin.com/in/allisonkomiyama/?utm_campaign=14405047-Live%21%20%2388%20-%20Electric%20Brains%20%26%20Regulatory%20Pains%3A%20Accelerate%20Neurology%20Innovation%2C%20Slash%20Risk%2C%20%26%20Win%20Approval&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8qe5VQAE-8wVsZyqt64UpKbBoJimwpWQN-CjWgf7LhpMJmz6eq53OQXsl5eTWihEpVs5Bt" target="_blank" rel="noopener"><strong>Allison Komiyama, Ph.D., RAC</strong></a> – Vice President, MedTech Innovation</li><li>🧠 <a href="https://www.linkedin.com/in/bethany-knorr-chung-phd-rac-ab4207162/?utm_campaign=14405047-Live%21%20%2388%20-%20Electric%20Brains%20%26%20Regulatory%20Pains%3A%20Accelerate%20Neurology%20Innovation%2C%20Slash%20Risk%2C%20%26%20Win%20Approval&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8qe5VQAE-8wVsZyqt64UpKbBoJimwpWQN-CjWgf7LhpMJmz6eq53OQXsl5eTWihEpVs5Bt" target="_blank" rel="noopener"><strong>Bethany Knorr Chung, Ph.D., RAC</strong></a> – Senior Manager, Technical</li><li>🧠 <a href="https://www.linkedin.com/in/christinesantagate/?utm_campaign=14405047-Live%21%20%2388%20-%20Electric%20Brains%20%26%20Regulatory%20Pains%3A%20Accelerate%20Neurology%20Innovation%2C%20Slash%20Risk%2C%20%26%20Win%20Approval&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8qe5VQAE-8wVsZyqt64UpKbBoJimwpWQN-CjWgf7LhpMJmz6eq53OQXsl5eTWihEpVs5Bt" target="_blank" rel="noopener"><strong>Christine Santagate, RAC</strong></a> – Vice President, Lab Services</li><li>🧠 <a href="https://www.linkedin.com/in/jonathangimbel/?utm_campaign=14405047-Live%21%20%2388%20-%20Electric%20Brains%20%26%20Regulatory%20Pains%3A%20Accelerate%20Neurology%20Innovation%2C%20Slash%20Risk%2C%20%26%20Win%20Approval&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8qe5VQAE-8wVsZyqt64UpKbBoJimwpWQN-CjWgf7LhpMJmz6eq53OQXsl5eTWihEpVs5Bt" target="_blank" rel="noopener"><strong>Jon Gimbel, Ph.D.</strong></a> – Vice President, Technical (moderator)</li></ul><p> </p><p><strong>Timestamps</strong></p><p>00:00 Introduction to Neurology Innovation and Regulatory Challenges<br>02:57 Panelist Introductions and Their Expertise<br>05:54 Exciting Developments in Neurological Devices<br>08:48 The Role of AI and Machine Learning in Neurology<br>11:58 Testing and Safety Considerations for Neurological Devices<br>14:51 Regulatory Framework and Challenges for Neurological Devices<br>19:00 Ethical Considerations in Neurological Device Development<br>35:20 Ethical Considerations in Medical Devices<br>36:47 Patient Information and Healthcare Provider Communication<br>39:03 Regulatory Perspectives on Device Usability<br>42:57 Challenges in Medical Device Studies<br>46:58 Real World Evidence in Medical Device Evaluation<br>51:10 Navigating Regulatory Pathways: FDA vs. EU<br>55:55 The Future of Medical Device Regulation<br>01:01:30 Exciting Innovations in Neurological Treatments<br>01:06:49 Concluding Thoughts on Clinical Trials and Future Directions</p><p><br></p><p><strong>More neurology resources from RQM+</strong></p><ul><li><a href="https://www.rqmplus.com/blog/ai-regulatory-landscape-of-neurological-devices/?utm_campaign=14405047-Live%21%20%2388%20-%20Electric%20Brains%20%26%20Regulatory%20Pains%3A%20Accelerate%20Neurology%20Innovation%2C%20Slash%20Risk%2C%20%26%20Win%20Approval&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8qe5VQAE-8wVsZyqt64UpKbBoJimwpWQN-CjWgf7LhpMJmz6eq53OQXsl5eTWihEpVs5Bt" target="_blank" rel="noopener">Wires to AI: The Regulatory Landscape of Neurological Devices</a></li><li><a href="https://www.rqmplus.com/blog/artificial-neural-network-supporting-biological-neural-networks/?utm_campaign=14405047-Live%21%20%2388%20-%20Electric%20Brains%20%26%20Regulatory%20Pains%3A%20Accelerate%20Neurology%20Innovation%2C%20Slash%20Risk%2C%20%26%20Win%20Approval&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8qe5VQAE-8wVsZyqt64UpKbBoJimwpWQN-CjWgf7LhpMJmz6eq53OQXsl5eTWihEpVs5Bt" target="_blank" rel="noopener">Artificial Neural Network Supporting Biological Neural Networks</a></li><li><a href="https://www.rqmplus.com/blog/what-is-the-benefit-of-seeing-the-brain/?utm_campaign=14405047-Live%21%20%2388%20-%20Electric%20Brains%20%26%20Regulatory%20Pains%3A%20Accelerate%20Neurology%20Innovation%2C%20Slash%20Risk%2C%20%26%20Win%20Approval&utm_source=hs_email&utm_medium=email&_hsenc=p2ANqtz-8qe5VQAE-8wVsZyqt64UpKbBoJimwpWQN-CjWgf7LhpMJmz6eq53OQXsl5eTWihEpVs5Bt" target="_blank" rel="noopener">What is the Benefit of Seeing the Brain?</a></li></ul><p></p><p>--</p><p>📲<a href="https://www.linkedin.com/company/rqmplus/">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Follow RQM+ on LinkedIn.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a></p><p>💼<a href="https://www.rqmplus.com/careers#open-positions">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Check out our open positions.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a></p><p>📚<a href="https://www.rqmplus.com/expert-content">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠See free on-demand content.⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a></p><p>📝 If you&#39;d like to speak with us directly about how we might be able to support you and your organization, you&#39;re welcome to use <a href="https://www.rqmplus.com/book-consultation">⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠our contact form⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠</a>.</p>