New development to help treat neuropathy in the feet

[Ellis79]

This is new idea that researchers here in Israel have been working on. Still at the early stages but looks promising

http://www.timesofisrael.com/hebrew-us-smart-socks-can-help-save-diabetics-feet/

 

[Ellis79]

Interesting as it seems like a wearble tens machine however it is one of those articles that gives you no sense of cost or availability

I don't think the author could have given a sense of cost or availability even if he wanted to since any new medical device will need FDA approval and/or CE Mark certification before it can be sold commercially and healthcare insurers are willing to underwrite at least part of the cost. Sadly, some new ideas never progress beyond the early development stages for various reasons. This one looks like it might but of course you never know.

 

[Ellis79]

I actually think that the technology as described would not require FDA approval to be sold, but it might require the same for health insurance claims coverage. It is similar to a tens machine and tens machines have been marketed for a long time and are already approved at the advice of physicians for physical therapy, particularly sorts of tens machine for diabetic neuropathies of the feet and legs. I personally have no idea of the efficaciousness of the tens machines but would love to hear from anyone on the forum who has used them.

You are probably right where Europe is concerned, but anyone wishing to get a device onto the US market would almost certainly file what is known as a '510(k) pre-market notification' with the FDA, which as the authority's own website states "demonstrates that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to pre - market approval" - in other words, it's not compulsory but worth doing anyway. In the US, at least, that would go a long way towards to qualifying for coverage. I fancy trying out a TENS machine myself, for my back - I often get muscle spasms when getting out of bed in the morning - rather than neuropathy, which, luckily, I haven't suffered too much from recently.