FDA approves seizure-detecting wristband for pediatric use

  • FDA

  • curated by Emily Willingham, PhD
  • Clinical Essentials
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Takeaway

  • The FDA has given the nod to Empatica to market its seizure-detecting Embrace wrist wearable for use in children ages 6 and up.
  • The watch requires a prescription and detects generalized tonic-clonic seizures without using EEG.

Why this matters 

  • 1 in 5 people with epilepsy has tonic-clonic seizures, which are linked to sudden unexpected death in epilepsy (SUDEP).
  • SUDEP is second only to stroke as a neurological cause of loss of life years in the United States.
  • For people whose medication does not fully control tonic-clonic seizures, caregiver presence reduces SUDEP risk.
  • The smartband “improves the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens,” company cofounder and MIT professor Rosalind Picard said in a statement .

Key information

  • 300,000 US children under age 14 years have epilepsy.
  • Device detects seizures by picking up on motion patterns and physiological signals.
  • At detection, it sends an alert to a caregiver wireless device.
  • A prescription must be uploaded to the manufacturer’s site.
  • FDA approved Embrace for adults in February 2018.
  • Clinicians can use data from the device to guide treatment.
  • Approval was based on clinical trial showing 98% accuracy, detecting 53/54 seizures among 141 participants (n=80, ages 6-21 years).

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