FDA Authorizes Marketing of Device to Improve Gait in Multip
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The U.S. FDA authorized the marketing of a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). Portable Neuromodulation Stimulator (PoNS) is a neuromuscular tongue stimulator. The device is intended to be used by prescription only as an adjunct to a supervised therapeutic exercise program.

PoNS device delivers mild neuromuscular electrical stimulation to the dorsal surface of the patient's tongue. Receptors on the tongue send millions of neural impulses to the brain through natural pathways. The device is non-implantable and consists of a controller and a mouthpiece that are connected to each other by a cord.

The FDA assessed the safety and effectiveness of the PoNS device through two clinical studies and a retrospective analysis of real-world data. The primary outcome measure was the Dynamic Gait Index (DGI) The PoNS group on average achieved improvement in their DGI score of 7.95 at the end of the study, which was statistically significant and clinically significant.

In the first study, seven patients used the PoNS device and the other seven used a sham device. The PoNS group showed a statistically significant improvement in SOT scores at 14 weeks compared to the baseline value. Analysis of DGI scores after 14 weeks showed no significant result. The PoNS device has not been tested on, and thus should not be used by, individuals under the age of 22 or who are pregnant.

The PoNS device was granted Breakthrough Device designation, which is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA approved the PoNS device through the De Novo premarket review pathway. This is a regulatory pathway for low-to moderate-risk devices of a new type.

Source:
https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-device-improve-gait-multiple-sclerosis-patients
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