PONs FDA Applination

To anyone interested, I saw an announcement that Helius Medical submitted their FDA application for approval of the PONs device yesterday. A decision should be reached by the FDA in 4 months. As I have said before, the study is a bit odd,so approval is not a certainty. The approval is for balance problems associated with TBI, and they plan an MS study. I have no idea if it would help us.

:slightly_smiling_face: You just never know, fingers crossed :slightly_smiling_face: xB

Another door opening? :grinning:

Interesting! Once they get the FDA approval, it will be first studied in patients with MS, cerebral palsy and Parkinsonism. But it’s benefit may extend to other neurological “Movement Disorder”.

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I hope it is also explored for Alzheimer’s, too. Note that insurance will not pay for it yet and it is used in conjunction with a PT and exercise program. Once the FDA approves the thing, it will also be submitted for approval in Europe, Asia, and Australia. I got the idea that the regulatory bodies in all these places rely on the FDA for this. I heard a rumor that it is available now in Russia. I hope that it helps us!

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What is TBI? Don’t do abreviations well😎

Traumatic Brain Injury (TBI). Usually caused by an accident. But they can be incidental as well as in some forms causing ataxia. Some can make a full recovery some cannot.

For those interested, (like me) here is the link to read up on: PoNS device (Portable Neuromodulation Stimulator)

Sorry, maryseas. I type with one finger since my left hand works so poorly,so I use abbreviations a lot. You are not the only one to whom I make no sense. I will try to improve, I am glad you got a great answer to your question…