FDA grants expanded 510(k) clearance for Epitel’s wireless EEG system
The US Food and Drug Administration (FDA) has granted expanded 510(k) clearance for Epitel’s REMI Wireless electroencephalogram (EEG) System for neurological monitoring in infants and paediatric patients aged one year and above. According to the company, the system’s design offers a “comfortable” experience, averting children from wire pulling or electrode displacing, which could compromise the integrity of the data. Additionally, the system’s setup and extended monitoring claims to offer wireless brain health examination at home or hospital with no constraints associated with a tethered system.
