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.