Event detection accuracy

Updated:

We are constantly validating and improving our algorithm, to test its accuracy we collaborate with top hospitals.

By December 2018, clinical testing was performed to demonstrate the ability of the Embrace as a seizure monitoring aid.

During the clinical testing, 141 patients diagnosed with epilepsy were continuously monitored. This lead to 9806 hours or 409 days of data, including 54 generalized tonic-clonic seizures. The trial was supervised by 3 board-certified clinical neurologists who independently examined the data. Embrace's algorithm was shown to detect 98% of the seizures, The false alarm rate was 0.94 per day.

 

The full details of this work are included in this document, in the section titled, "Clinical testing":

https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181861.pdf

 

 

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