Show notes
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.SummaryHear 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) Timestamps00:00 Introduction to Neurology Innovation and Regulatory Challenges02:57 Panelist Introductions and Their Expertise05:54 Exciting Developments in Neurological Devices08:48 The Role of AI and Machine Learning in Neurology11:58 Testing and Safety Considerations for Neurological Devices14:51 Regulatory Framework and Challenges for Neurological Devices19:00 Ethical Considerations in Neurological Device Development35:20 Ethical Considerations in Medical Devices36:47 Patient Information and Healthcare Provider Communication39:03 Regulatory Perspectives on Device Usability42:57 Challenges in Medical Device Studies46:58 Real World Evidence in Medical Device Evaluation51:10 Navigating Regulatory Pathways: FDA vs. EU55:55 The Future of Medical Device Regulation01:01:30 Exciting Innovations in Neurological Treatments01:06:49 Concluding Thoughts on Clinical Trials and Future DirectionsMore neurology resources from RQM+Wires to AI: The Regulatory Landscape of Neurological DevicesArtificial Neural Network Supporting Biological Neural NetworksWhat is the Benefit of Seeing the Brain?--📲Follow RQM+ on LinkedIn.💼Check out our open positions.📚See free on-demand content.📝 If you'd like to speak with us directly about how we might be able to support you and your organization, you're welcome to use our contact form.
