Separate names with a comma.
Please remember that a small clinical trial group emphasizes both super responders and super non-responders. Both can skew data in either direction.
In the same way that insulin doesn't work because diabetics need to keep injecting it? Get a grip; it's a treatment, not a cure.
Not quite. CE marking is proving the safety of your device via a notified body by showing you adhere to the Medical Device Regulations. It’s a...
Saddening, but how many conditions have absolutely nothing on the horizon? Not saying the device will meet our hopes for volume reduction, but...
You're probably right. We work with many start-ups, but they have permanent staff that need to be put on the next iteration even prior to launch....
I can’t speak for Auricle specifically, but yes, you would. You can’t change ANY manufacturing processes or specifications after you submit....
I’m not quite sure I understand this. Can someone please explain? When the company I work for submits a new product to regulators that we...
Also, don’t forget the sampling bias for one audiologist who will happily profit from selling it to you. Many people who are not on Tinnitus Talk...
Of course, they can. But don’t get fragile and offended when someone asks you to back up your constant stream of ‘opinion’ with data on how you...
Even though this post is still large, I had a bigger response about how multiple people here are purposely obtuse and ignoring the plethora of...
Of course there does need to be a balance. But there also has to be a balance to unsubstantiated claims like yours where it may be ‘detrimental.’...
Once it hits the market, do you want a team of scientists and engineers who designed the device to remain in control and continuously revise and...
This doesn’t make sense. 99.99% of drugs and therapies on the market have zero doctor involvement. They treat patients, not develop the...
In the last 1.5 years, they published their final study and said they were preparing for FDA submission. We’re not getting updates on the...
Not really. It's a well-executed study. It's difficult for me to provide any objective evidence as the devices I normally deal with, a placebo...
