This is the fifth 510(k) clearance for the company’s REMI portfolio, with the first clearance obtained in March 2021.
Younger children and infants at least one year of age benefit from a wireless system that integrates brain health monitoring into a child’s regular routine with drastically less disruption than ...
today announced that the U.S. Food and Drug Administration (FDA) has granted another 510(k) Clearance for the REMI™ Wireless EEG System, expanding the Indications for Use of their revolutionary ...