look, let's be honest - will it make you feel better if they punish the doctor who missed your cancer? yes, you will not care about it, and all thoughts will be about how to achieve remission. I personally communicate with several people who have missed melanoma and they are now at stage 4 with brain metastases. yes, the doctor's license was revoked. but the cancer hasn't gone away
we will soon put the necessary certificates FDA on the site, so that you do not worry. we do not encourage you to refuse to go to the doctor, if you have such an opportunity. and as for your scenarios - the app has the ability to refine the measurements. if your mole is healthy and the doctor has confirmed it, specify it in the application. then, if there are any changes, the device will show them. especially if there have already been precedents with melanoma or other types of skin cancer.
So far no "FDA certificates" are posted. Instead, you run a rush campaign asking people to buy it within two days to save $130. Why would anyone in their right mind buy this before having any proof this actually works?
it's great that you asked about clinical trials. we conducted them blindly, with the participation of several doctors. the device measured the mole, and then it was examined by a doctor. after that, a biopsy and histology were performed. these data were compared. now this data is unstructured and the histology documents contain personal data of people. but I will soon process everything and also post it on the site. I didn't think it was interesting. everyone needs FDA and 510k certificates
My bad. I asked two questions. Thanks for answering the second one. Raises already some confidence.
But could you answer the first (and more important one)? The website is silent on this topic.
Would be cool. Wish you all the best for your product launch.
sorry, I didn't understand your first question. we have been certified as a medical device, but we do not plan to enter the market of doctors. we originally developed NOTA as a device for home diagnostics of moles. However, when we wanted to get the 510k FDA certificate, we were told that they would test the device as a medical device, because there was already a precedent in 2018.
if I still haven't answered your first question, please clarify
just then you should understand how important early diagnosis is. take care of yourself and go to the doctor regularly. all the buyers of the device just survived melanoma
Could you provide a link to evidence obtained using your own device? Or perhaps a description of the tests you performed to determine substantial equivalence to the predicate devices?
I would be curious to see anything which lays out the specific claims and the evidence or justification used. For example, do you claim to detect malignant moles and if so what tests have you performed to demonstrate this. The language varies somewhat on your website so the approval documents or the information you described would be helpful to understand the device better.
it's great that you asked about clinical trials. we conducted them blindly, with the participation of several doctors. the device measured the mole, and then it was examined by a doctor. after that, a biopsy and histology were performed. these data were compared. now this data is unstructured and the histology documents contain personal data of people. but I will soon process everything and also post it on the site. I didn't think it was interesting. everyone needs FDA and 510k certificates
the best defense against cancer is early diagnosis. the point of the device is to help with this. if you have the opportunity to check moles with a doctor - it is better to do it with him.
I'll tell you a secret-human life ends. and all of us will leave this world sooner or later. but to die because of old age, in the circle of grandchildren and great-grandchildren, or at the age of 40 from a missed cancer-it's up to you. I just encourage people to take care of their health. if you don't like the device, make an appointment with your doctor. it's summer (if you're not from South Africa or Australia), it's time to check out your moles
A site search of he FDA for a device other than the one you’re marketing, and a link to an article in some low-impact-factor journal I’ve never heard of?
