Helius Provides More Information to FDA About PoNS Device

Helius Provides More Information to FDA About PoNS Device

282547

Helius Provides More Information to FDA About PoNS Device

Helius Medical Technologies has submitted its response to the U.S. Food and Drug Administration (FDA)’s request for more information about the company’s application for de novo classification and clearance of its portable neuromodulation stimulator (PoNS) device to help treat walking difficulties in people with multiple sclerosis (MS). Helius submitted its request in August. In October the company announced the FDA had requested additional information and the application was placed on hold until the agency received the requested…

You must be logged in to read/download the full post.