Helius Medical Technologies Inc. reported that the U.S. FDA rejected the company's request for de novo classification and 510(k) clearance for its Portable Neuromodulation Stimulator (PoNS) device. The FDA cited inadequate evidence to discriminate between the benefit of the device vs. the physical therapy participants with traumatic brain injury (TBI) received in the submitted studies, though it left open the door to resubmission with additional data. PoNS received clearance from Health Canada in October 2018. Read More
