FDA Approves Groundbreaking Technologies for Epilepsy Monitoring: Embrace Smartwatch and Minder Implantable EEG System
• The FDA has approved Empatica's Embrace smartwatch, which uses machine learning and electrodermal activity monitoring to detect generalized tonic-clonic seizures with 100% accuracy in clinical trials.
• Epiminder's Minder system has received FDA De Novo classification and Breakthrough Device designation as the first implantable continuous EEG monitoring system that can track brain activity for months or years.
• These innovations address critical gaps in epilepsy management, potentially reducing the 3,000+ annual deaths from Sudden Unexpected Death in Epilepsy (SUDEP) and improving care for the 3.4 million Americans with epilepsy.
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