FDA Rejects Helius’ De Novo Application For PoNS To Treat Brain Injury
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.
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Neuromodulation start-up Helius Medical Technologies is employing a simpler, more primal connection to send potentially therapeutic signals to the brain – the tongue. The company is entering pivotal clinical trials to test the technology in select patients with traumatic balance disorder and traumatic brain injury, and evaluating the device for use in patients with multiple sclerosis.
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