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Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand™ Upper Extremity Rehabilitation System
April 26, 2021 07:00 ET | Source: Neurolutions Neurolutions
IpsiHand also has been granted U.S. FDA Breakthrough Device Designation
SANTA CRUZ, Calif. and ST. LOUIS, Mo., April 26, 2021 (GLOBE NEWSWIRE) Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-computer interface (BCI) technology for upper extremity chronic stroke rehabilitation, announced today that the U.S. Food and Drug Administration (FDA) granted De Novo market authorization for its groundbreaking IpsiHand Upper Extremity Rehabilitation System. The IpsiHand System has been cleared for use in chronic stroke patients to facilitate muscle re-education through its novel BCI platform. In addition to the De Novo Authorization, the IpsiHand device notably received Breakthrough Device