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? -- 📲⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠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.