Helius Medical Technologies Inc. has received an FDA breakthrough device designation for its Portable Neuromodulation Stimulator (Pons) device for temporary treatment of dynamic gait and balance deficits due to stroke.
The FDA authorized marketing of the Portable Neuromodulation Stimulator (Pons) for short-term treatment of gait issues arising from mild to moderate symptoms associated with multiple sclerosis (MS) through its de novo pathway. Helius Medical Inc., a subsidiary of Helius Medical Technologies Inc., makes the non-implantable neuromuscular tongue stimulator.