Helius Medical Technologies, Inc. Provides Update on FDA’s Review of its Request for De Novo Classification and 510(k) Clearance of the PoNS™ Device

Helius Medical Technologies, Inc. announced that it has received a request for additional information (“AI”) letter from the U.S. Food and Drug Administration (the “FDA”) related to the Company’s request for De Novo classification and 510(k) clearance of the Portable Neuromodulation Stimulator (PoNS™) device. During the substantive review phase of a request for De Novo classification and 510(k) clearance, FDA may request additional information in order to obtain information necessary for the agency to continue or complete its review and, in such instances, places its review on hold until the requested information is submitted.