Remedee's endorphin stimulator for fibromyalgia gains FDA breakthrough status

https://www.firstwordhealthtech.com/story/5570485

Remedee Labs announced Thursday that the FDA granted a breakthrough therapy device designation to its endorphin stimulator for patients with fibromyalgia. CEO David Crouzier called the achievement a "major step, one that recognises [the product's] potential for treating fibromyalgia patients' pain."

The technology uses peripheral stimulation to trigger the release of endorphins, potentially offering fibromyalgia patients a non-pharmaceutical way of relieving symptoms such as pain, sleep disorders, fatigue and stiffness. According to Remedee's website, the solution is based on its Microelectronic Endorphin Trigger (MEET) module. By using low-energy, high-frequency electromagnetic waves, Remedee says the stimulator activates the body's peripheral sensitive nervous system to send a message to the brain to release endorphins.

 

https://remedeelabs.com/endorphin-stimulation/

Our team of scientists and medical technology experts has developed a millimeter wave (MMW) medical technology solution that uses peripheral stimulation to trigger the release of endorphins, the body’s natural way of making pain more manageable. The MEET solution enables on-demand stimulation of a person’s own endorphins, to increase endorphin levels. By using low-energy, high-frequency electromagnetic waves, the Remedee Labs solution activates the body’s peripheral sensitive nervous system to send a message to the brain to release endorphins, providing rapid, natural pain relief. In short, changing the way we approach pain management.

Our first endorphin-stimulator has already been tested in a safety clinical trial. Multiple clinical trials are now underway by leading hospitals and research centers to test its effectiveness on specific pain applications, including arthritic pain relief and migraine.

 

It's probably just me but the language they are using makes this sound like hokum, to me.

e.g.
"By using low-energy, high-frequency electromagnetic waves"
so....it buzzes and produces no noticeable/detectable effect?
"activates the body’s peripheral sensitive nervous system"
erm...as opposed to what? the bodies insensitive core nervous system?

 

I'm sorry but Remedee for the name of a 'serious' medical device?

May your wishes some true.

 

They probably just haven't realised that someone invented the vibrator really quite a long time ago.

 

I guess they will make lots of money…and can see many people buying it or creating fakes to peddle soon

the only “scientific research” over the past 30 years mentioned on their website that I could find on MMV and FM was this.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3153879/

Sounds like it was used in private clinics in Russia and Eastern European countries, so maybe there is research not published in the Anglosphere.

 

I don't think 'peripheral stimulation' has anything to do with transcranial magnetic stimulation (which is used to treat severe depression and is being studied for use in FM and other disorders).

This remedying thingie sounds akin to a TENS unit albeit with different electrical properties. But I am disinterested enough not to delve.

 

Planck's Equation E = hv

That is to say that low energy=low frequency, high energy =high frequency, so there's no such thing as:

Low energy, high frequency

It's garbage.