Helius Medical Technologies announced its wholly owned subsidiary, NeuroHabilitation Corporation, received authorization from Health Canada to market its Portable Neuromodulation Stimulator (PoNSTM), a class II medical device in Canada.
On August 20, 2018, CMS released an announcement about the asset purchase of the Products – the portable neurostimulation devices (whether under the name of PoNS Devices or otherwise). On September 4, Helius submitted a de novo classification and 510(k) clearance to the US Food and Drug Administration (FDA) for the treatment of PoNS devices for chronic balance disorders caused by mild to moderate traumatic brain injury (TBI). PoNS is a class II medical device developed for the adjuvant treatment of balance disorders in patients with TBI, stroke, cerebral palsy, etc.
CMS has been fully working on the regulatory application of class II medical device and other related work for PoNS in China.