Empatica's Embrace an AI Smartwatch Receives FDA's 510(K) Clearance Approval in Pediatric Patients Aged ≥6 yrs.
Shots:
- The approval is based on clinical trials assessing Embrace in 141 patients including 80 pediatric with epilepsy aged 6 to 21 years (generalized tonic-clonic seizures) after winning clearance for adults with epilepsy
- The study demonstrated in 98% accuracy and detecting tonic leisure (53 out of 54 patients)
- Embrace is non ECG based AI watch used for detecting patterns in motion and physiological signals associated with generalized tonic-clonic seizures by alerting caregivers and has received EU’s CE Mark approval in 2017
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