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.
You just never know, fingers crossed xB
Another door opening?
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”.
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!
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…