- 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 .
- 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).