7 ms·

My friend’s startup is doing great stuff in this space to make a VNS device for consumers. https://zenbud.health/ https://zenbud.health/

dark-star 1y ago
Do these work the same as the professional/medical ones? A friend of mine had one during a study, and she claimed it worked by electrostimulation (small electric shocks), not ultrasonic waves? She wanted to buy one of those devices because they really helped her but the cost was upwards of 1500€, this would probably be within range for her, assuming it works the same way?
- metalman 1y ago
  text says "implanted device", which is going to put in by a neuro surgeon
  - dark-star 1y ago
    I wasn't talking about the article, I was replying to a comment about the zenbuds
m101010 1y ago
They promote their peer-reviewed clinical trial in the header area. However, the spelling mistake 'Tial' should be fixed asap :) Maybe you can tell him that and also tell him that I am quite interested in the device to check if it can reduce my heart palpitations!
j45 1y ago
Neat, sensate is another device in this area. Bio and neurofeedback devices are going to be an interesting space the next 10 years.
ajb 1y ago
I'm skeptical of these devices that say they are safe based on CE or FCC testing. (zenbud says it has been CE tested). That's consumer product testing, not health-device testing; I would like to see some evidence that long-term use of a nerve stimulation device causes no long term damage. I don't believe that CE or FCC tests show that. It's disingenuous to have a press release saying "Yay! We passed CE testing!" as if that was like FDA approval.
- deno 1y ago
  FWIW the EU also has EUDAMED registry for producers, distributors and importers of medical devices and there are additional regulations beyond CE under the MDR directive. I don't see "ZenBud" or "NeurGear" in the EUDAMED database. An ultrasonic device delivering energy to human tissue would be a class 2a or 2b active medical device under MDR.

dark-star 1y ago

Do these work the same as the professional/medical ones? A friend of mine had one during a study, and she claimed it worked by electrostimulation (small electric shocks), not ultrasonic waves? She wanted to buy one of those devices because they really helped her but the cost was upwards of 1500€, this would probably be within range for her, assuming it works the same way?

metalman 1y ago
text says "implanted device", which is going to put in by a neuro surgeon
- dark-star 1y ago
  I wasn't talking about the article, I was replying to a comment about the zenbuds

m101010 1y ago

They promote their peer-reviewed clinical trial in the header area. However, the spelling mistake 'Tial' should be fixed asap :) Maybe you can tell him that and also tell him that I am quite interested in the device to check if it can reduce my heart palpitations!

j45 1y ago

Neat, sensate is another device in this area. Bio and neurofeedback devices are going to be an interesting space the next 10 years.

ajb 1y ago

I'm skeptical of these devices that say they are safe based on CE or FCC testing. (zenbud says it has been CE tested). That's consumer product testing, not health-device testing; I would like to see some evidence that long-term use of a nerve stimulation device causes no long term damage. I don't believe that CE or FCC tests show that. It's disingenuous to have a press release saying "Yay! We passed CE testing!" as if that was like FDA approval.

deno 1y ago
FWIW the EU also has EUDAMED registry for producers, distributors and importers of medical devices and there are additional regulations beyond CE under the MDR directive. I don't see "ZenBud" or "NeurGear" in the EUDAMED database. An ultrasonic device delivering energy to human tissue would be a class 2a or 2b active medical device under MDR.