Helius Medical Technologies, Inc. Announces FDA Has Granted the PoNS Device Breakthrough Device Desi...May 12, 2020UPDATE -- Helius Medical Technologies, Inc. Announces Publication of its PoNS™ Registrational Clin...Apr 30, 2020
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PoNS™ is an authorized medical device and commercially available in Canada. PoNS™ is an investigational device in the US, EU, and Australia and is currently under review for market clearance by the AUS TGA; PoNS™ is not commercially available in the US, EU, or Australia.
The device is intended for use as a short term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The device is intended for use as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy.