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Helius Seeks FDA De Novo For Portable Neuromodulation Stimulator For MS Patients

 
• By Reed Miller

The FDA has asked the company for more information to support its PoNS therapy for multiple sclerosis patients with gait deficit, including an additional analysis of clinical data and labeling modifications.

Occupational therapy
• Source: shutterstock.com

The US Food and Drug Administration has asked Helius Medical Technologies, Inc. for additional information to support its de novo application for its portable neuromodulation stimulator (PoNS) as a therapy to treat walking difficulties related to multiple sclerosis (MS), the company announced on 19 October.

PoNS is a portable, non-invasive neuromodulation stimulator with an electrode array that delivers small electrical pulses to the user’s tongue. Research has consistently shown the tongue can be an effective...

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More from Policy & Regulation

Commission’s Flora Giorgio Says Simplification And Safety Are Key In Evolving EU Regs

 
• By Amanda Maxwell

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.