trending Market Intelligence /marketintelligence/en/news-insights/trending/ldejy4yikesxplojawbcza2 content
Log in to other products

Login to Market Intelligence Platform


Looking for more?

Contact Us
In This List

Helius Medical seeks US FDA clearance for neuromodulation device

COVID-19 Pandemic Likely To Cause US Telemedicine Boom

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry


IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

Helius Medical seeks US FDA clearance for neuromodulation device

Helius Medical Technologies Inc. is seeking de novo classification and 510(k) clearance from the U.S. Food and Drug Administration for its portable neuromodulation stimulator device.

Portable neuromodulation stimulator, or PoNS, is an investigational, noninvasive medical device intended to treat chronic neurological symptoms of disease or trauma. The de novo status allows PoNS to be determined as novel, with no existing classification or predicate device available on the market.

The company's application is supported by the results of two studies which showed the device's safety and effectiveness in 163 patients who suffered from traumatic brain injury.

Newtown, Pa.-based Helius Medical is a medical technology company engaged in the development of noninvasive products intended to increase the brain's ability to heal itself.