Episode description
🎥 We're starting off the week right with a NEW MedTech Voices 🚨
Join our Medical Director Sally Sennitt and VP of Intelligence and Innovation Jaishankar Kutty, Ph.D. as they dissect the expert panel review of a groundbreaking neurostimulator designed to treat focal epilepsy in adults. 🧠⚡
Why watch?🤔
1️⃣ Gain Insights into the Complexities of Regulatory Approvals:
Understand the expert panel's concerns over data sufficiency and quality, and learn why a well-defined intended use is crucial.
2️⃣ Learn the Importance of Comprehensive Data:
Dive into the nitty-gritty of patient selection, stimulation parameters, and electrode locations; see what’s lacking and what could be improved.
But there's more...
👀 Extra Focus on Safety & Performance:
This clip raises important questions about the device’s safety in terms of its impact on seizure frequencies, which translates to several valuable lessons applicable to a wide range of devices.
📈 Potential for Patient Impact:
Given the prevalence of refractory epilepsy and limitations of existing treatments, it's easy to appreciate the significant opportunity this device could present... if only the data were better analyzed and presented.
We encourage any discussion in the comments and would love to hear your thoughts or questions about this complex, innovative device. 🙏
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