[ANN] ⚡ HEALTH MONITOR⚡ | Soft cap reached - ICO ending today | 1200 tokens left - page 13.

matjas

full member

Activity: 798

Merit: 115

Quote from: weekofcrypto on December 19, 2017, 03:53:46 PM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

I wouldn't think FDA approval is needed, but I bet they need a disclaimer about the results not being medical recommendations and to consult a doctor first.

They really need to think it all through. Sanitary rules, instructions, extra emphasize on accuracy of results and the distribution network. This project needs a lot of careful planning in order to succeed.

weekofcrypto

member

Activity: 93

Merit: 10

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

I wouldn't think FDA approval is needed, but I bet they need a disclaimer about the results not being medical recommendations and to consult a doctor first.

the_donald

full member

Activity: 588

Merit: 100

Quote from: BY_ATOM on December 19, 2017, 03:26:55 PM

Quote from: MandatoryOption on December 19, 2017, 07:27:33 AM

Quote from: Rigorous on December 19, 2017, 07:19:00 AM

Quote from: PS92 on December 18, 2017, 07:47:01 PM

Quote from: Rigorous on December 18, 2017, 06:39:56 PM

Maybe an exception could be border control at airports, testing for contagious diseases, but at this stage Health Monitor is not testing for such afflictions.

Wow that is a cool use case, but then it would be mostly about the health tech behind the machine and not the blockchain part. No one will pay for a test on contagious diseases if ordered by border control

Of course someone is willing to pay. Border control!

Although having to insert a fiver for every passenger is a bit clunky. I wonder if there could be an alternative payment method, something like prepaid. Border control could buy tokens, associate them with their account and link the device to that account.

I don't know if it's possible to transfer the testing mechanism of Health Monitor to contagious diseases.

I think that everything is possible. The only question is the financial cost and the availability of the necessary certificates and patented technology!

It all depends on the types of diseases and their markers. if they emit various types of gas like the ones detected by health monitor then yes.

hanshammer

member

Activity: 280

Merit: 22

The Future of Sports is Fan Controlled

Quote from: ?? on ??

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

i did not think it took so long to get medical certification, meanwhile it is important to start the distribution also as non-medical machinery, then once installed, created a capillary network, in a second time you can ask for a medical license...

Very creazy that it takes 2 years to get a medical certification. Let's hope the best that you get it as fast as possible.

BY_ATOM

full member

Activity: 406

Merit: 107

Quote from: MandatoryOption on December 19, 2017, 07:27:33 AM

Quote from: Rigorous on December 19, 2017, 07:19:00 AM

Quote from: PS92 on December 18, 2017, 07:47:01 PM

Quote from: Rigorous on December 18, 2017, 06:39:56 PM

Maybe an exception could be border control at airports, testing for contagious diseases, but at this stage Health Monitor is not testing for such afflictions.

Wow that is a cool use case, but then it would be mostly about the health tech behind the machine and not the blockchain part. No one will pay for a test on contagious diseases if ordered by border control

Of course someone is willing to pay. Border control!

Although having to insert a fiver for every passenger is a bit clunky. I wonder if there could be an alternative payment method, something like prepaid. Border control could buy tokens, associate them with their account and link the device to that account.

I don't know if it's possible to transfer the testing mechanism of Health Monitor to contagious diseases.

I think that everything is possible. The only question is the financial cost and the availability of the necessary certificates and patented technology!

Voltaje

sr. member

Activity: 350

Merit: 250

Quote from: mandibleclaw on December 19, 2017, 12:57:48 PM

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

Eventually, it should get the medical certification, it will take some years, so meanwhile, they are not cranching it as medical, until the certification is approved, then it will, its what I would do, 2 years or so is a lot of time wasted.

batako

sr. member

Activity: 1022

Merit: 252

Quote from: bitcoin-shark on December 19, 2017, 02:26:58 PM

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

i did not think it took so long to get medical certification, meanwhile it is important to start the distribution also as non-medical machinery, then once installed, created a capillary network, in a second time you can ask for a medical license...

They can seek permission/licence as they go. As long as the equipment can benefit us, that will be enough at first stage.

bitcoin-shark

hero member

Activity: 2968

Merit: 605

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

i did not think it took so long to get medical certification, meanwhile it is important to start the distribution also as non-medical machinery, then once installed, created a capillary network, in a second time you can ask for a medical license...

belechau

full member

Activity: 686

Merit: 100

Quote from: Voltaje on December 19, 2017, 02:12:11 PM

Quote from: mandibleclaw on December 19, 2017, 12:57:48 PM

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

Eventually, it should get the medical certification, it will take some years, so meanwhile, they are not cranching it as medical, until the certification is approved, then it will, its what I would do, 2 years or so is a lot of time wasted.

Due to its usefulness and all the renown that will be achieved with demonstrations of operation, will not have difficulty in any type of certification, the visibility that will be provided by the demonstrations and for possible requests of partnerships with Companies of the medical branch, this will be applicable without problems , and for this reason I will be together and count on good earnings from HealthMonitor

Voltaje

sr. member

Activity: 350

Merit: 250

Quote from: mandibleclaw on December 19, 2017, 12:57:48 PM

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

Eventually, it should get the medical certification, it will take some years, so meanwhile, they are not cranching it as medical, until the certification is approved, then it will, its what I would do, 2 years or so is a lot of time wasted.

Voltaje

sr. member

Activity: 350

Merit: 250

Quote from: mandibleclaw on December 19, 2017, 12:57:48 PM

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

Eventually, it should get the medical certification, it will take some years, so meanwhile, they are not cranching it as medical, until the certification is approved, then it will, its what I would do, 2 years or so is a lot of time wasted.

mandibleclaw

member

Activity: 532

Merit: 50

ONe Social Network.

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

mandibleclaw

member

Activity: 532

Merit: 50

ONe Social Network.

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

mandibleclaw

member

Activity: 532

Merit: 50

ONe Social Network.

Quote from: maurobiasolo on December 19, 2017, 12:04:06 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

But it will remain forever a non-medical device or you're going to rebrand it to medical device in the future, or maybe you gonna brand the next version as medical?

matjas

full member

Activity: 798

Merit: 115

Quote from: maurobiasolo on December 19, 2017, 12:13:33 PM

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

Are you planning to get a FDA approval though?
As far as I understand, requirements for medical devices are much higher, hence it would be important for a lot of customers to know that it's FDA approved and that it fits all the standards.

maurobiasolo

full member

Activity: 602

Merit: 101

http://scientificcoin.com/

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

maurobiasolo

full member

Activity: 602

Merit: 101

http://scientificcoin.com/

Quote from: Jay2408 on December 19, 2017, 10:36:37 AM

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

It takes min. 2 years to get a medical certification and we want to go to market way before. That's why we are now branding our machine as a non-medical device.

Jay2408

full member

Activity: 518

Merit: 101

🚀🚀 ATHERO.IO 🚀🚀

Quote from: Sozialtourist on December 19, 2017, 10:21:41 AM

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Well, it's clearly said in their FAQ that Health Monitor is not a certified medical device but is classified just as an electrical device.
You're right, the FDA regulates also medical devices and is quite strict as far as I know.

SEELE^^01

full member

Activity: 952

Merit: 137

Quote from: niklasmato on December 18, 2017, 05:04:05 PM

Quote from: cantdecide on December 17, 2017, 09:49:58 PM

Quote from: SEELE^^01 on December 17, 2017, 05:13:02 PM

is there an app planned for tracking your diagnostics you did with the health monitor apparatus?

Oh this would be a good idea. You could get the diagnostics directly into the app and could show them then to the doctor afterwards, if there is need to go.

Well this is actually a very good idea to bundle this with some sort of information you can find online.

a tracking app could also be beneficial for health insurances. in germany for example, you can get a cashback on your yearly invested insurance back, if you visit your doctors frequently and do the annual checkups and or even use a tracking monitor for your health like fitbit and so on.

together with this, you could also get the health insurances on board and get even bigger

Sozialtourist

full member

Activity: 686

Merit: 101

Quote from: openair on December 19, 2017, 09:25:09 AM

I dont think FDA approval is needed, it’s usually for new drugs or medical product, not medical devices. HEALTH MONITOR is made for medical diagnostic so no problem for the safety of people using it.

Exactly, Health Monitor is a medical device. But I am sure there are FDA requirements for medical devices as well.

Topic: [ANN] ⚡ HEALTH MONITOR⚡ | Soft cap reached - ICO ending today | 1200 tokens left - page 13. (Read 39350 times)