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FDA Rejects Helius’ De Novo Application For PoNS To Treat Brain Injury

 
• By Reed Miller

Helius Medical announced on April 10 that the US FDA has declined its de novo application for treating brain injury with its Portable Neuromodulation Stimulator.

Not-Approved

The US FDA has turned down Helius Medical Technologies Inc.’s de novo application for the Portable Neuromodulation Stimulator (PoNS) system to treat brain injury after concluding that the company has not provided sufficient information to show therapy with the PoNS device provides benefits beyond what the patient gets from physical therapy.

PoNS is an electrical stimulator placed on the patient’s tongue to stimulate the trigeminal and facial nerves. Research suggests that stimulation of these two cranial nerves, in addition to physical...

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