Empatica secures FDA clearance for paediatric use of epilepsy smartband

04 February 2019


FDA

Massachusetts Institute of Technology (MIT) Media Lab spin-off, Empatica, has received the US Food and Drug Administration (FDA) 510(k) clearance for the use of its Embrace epilepsy smartband for children.

Embrace is designed to detect patterns in motion and physiological signals related to generalised tonic-clonic seizures. The smartband instantly notifies caregivers.

The signal seizure monitoring device has already secured the FDA clearance for use in adults. Embrace is powered by artificial intelligence (AI) technology and leverages advanced machine learning to detect seizures. It uses electrodermal activity (EDA) to measure several seizure indicators and quantify physiological changes related to the sympathetic nervous system activity.

“Embrace improves the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens.”
Empatica co-founder Rosalind Picard said: “We are so happy to provide Embrace with FDA’s formal clearance of its use by pediatric subjects aged 6-21. Embrace improves the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens. Having somebody present is associated with better health outcomes.”

Embrace was clinically tested at an Epilepsy Monitoring Unit (EMU) in a total of 141 epilepsy patients, including 80 paediatric participants aged 6-21 years and 61 adults.

Results showed that the smartband was able to detect 53 out of 54 generalised tonic-clonic seizures with 98% accuracy rate. Previous research found that 25% of the epilepsy patients have generalised tonic-clonic seizures, which could lead to sudden unexpected death in epilepsy (SUDEP).

Though seizure medication is considered as the best approach to prevent SUDEP, approximately 33% of patients’ seizures are not controlled by drugs. Empatica further noted that the risk of SUDEP is lowered in generalised tonic-clonic seizures patients if somebody is available with the patient when the seizure occurs.


Published by www.medicaldevice-network.com on January 9, 2019

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