There doesn’t seem to be any evidence provided as to whether this is actually an effect way of detecting cancerous moles. Given that that’s probably the most important question to answer for something like this, I’m going to assume there isn’t any evidence or else it would have been front and centre of the site.

Hello! here are the links - one to the FDA, see the Nevisense device https://search.usa.gov/search?utf8=%E2%9C%93&affiliate=fda1&.... the second is a scientific article on bioimpedance and diagnosis of melanoma https://drive.google.com/file/d/1VqlKzjrmjKiS_EtdEjkisBjBDb7.... also enter bioimpedance melanoma or bioimpedance skin cancer in google you will find a dozen articles with research there

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?

in what form do you want to get the data? I have a text from our researchers, but it's on Google drive. will this be significant for you?

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.

I think what they want is an independent, double-blind study,using your device that show statistical significance detecting malignant moles.

Independent verification is not always performed for 510k submissions, but yes that would be ideal

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

To be honest all this skin cancer detection stuff is kind of non-proven to be effective. Problem with this is that it leads to overtreatment and a non-measurable prolonging of life-time.

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.

No overtreatment is an concern. Just because you detect potential cancer earlier, does not mean that your life will be prolonged.

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

Says "scientific fact" on the landing page. No scientific paper cited.

Hello! here are the links - one to the FDA, see the Nevisense device https://search.usa.gov/search?utf8=%E2%9C%93&affiliate=fda1&.... the second is a scientific article on bioimpedance and diagnosis of melanoma https://drive.google.com/file/d/1VqlKzjrmjKiS_EtdEjkisBjBDb7.... also enter bioimpedance melanoma or bioimpedance skin cancer in google you will find a dozen articles with research there

What would I do with such a device? Let's say I have a suspicious mole, I use the device and test it. The output can be one of two:

1. This is a dangerous mole! see a dermatologist immediately. Consequence: I go to the doctor

2. This mole is clear. Consequence: I go to the doctor anyway, because this is not an FDA approved device and there's no guarantee for the accuracy. A doctor knows his/hers ass is on the line if he/she misdiagnoses a patient. Reading your terms of use, you waive all warranty for the accuracy of the device.

> A doctor knows his ass is on the line if he/she misdiagnoses a patient.

Its not, though, as long as he is working within accepted protocols.

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.

Edit: I’m not dignifying this junk with a real reply.

If you have any doubt, see a professional. Don’t trust this crap.

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

Definitely Interesting! Especially as the cited scientific papers tell us the principle is possible. But I wonder: has the manufacturer classified this as a medical device in the FDA sense?

Was it developed and tested like so? Question to the OP.

Yes, the device has been tested as a medical device and we will soon post certificates on the website.

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

But smart watches are NOT cheap. Not a price point I like, personally.

but they are cheaper than going to the doctor, especially if there is no insurance.

It depends where you live. In Europe you have it for free.

Spam and probably snake oil. Show me your FDA approval pls.

we will soon post the FDA certificates on the website. I hope that then you will be satisfied.

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?

we have been running the promotion for 2 weeks now. just in time to make the last payments for FDA certification:)

Theranos was FDA approved. The approval alone is meaningless. Without the results of a clinical trial using your device, it's as good as useless.

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

Hello there! here are the links - one to the FDA, see the Nevisense device https://search.usa.gov/search?utf8=%E2%9C%93&affiliate=fda1&.... the second is a scientific article on bioimpedance and diagnosis of melanoma https://drive.google.com/file/d/1VqlKzjrmjKiS_EtdEjkisBjBDb7... . also enter bioimpedance melanoma or bioimpedance skin cancer in google you will find a dozen articles with research there

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?

Solid.

you asked for confirmations - they are provided. and about fame - someone and DallasNews is an authoritative publication.

Huh? DallasNews?

exactly:) we will soon post the FDA certificates on the website. I hope that then you will be satisfied. or is the FDA not an indicator?

Can you clarify what you mean by certificates? Do you intend to link to approval documentation from a 510k clearance?

by certificates, I mean all documents that are issued after passing the FDA approval. including this 510K