Can MYDX launch a medical device in Canada or a 51
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Posted On: 10/23/2018 4:54:31 PM
Can MYDX launch a medical device in Canada or a 510k?
They are certainly capable of doing this however there is potential for another competitor to have begun to develop their own. If MYDX is unable to obtain first mover advantage they could be left in the dust. That being said until another similar device is approved MYDX remains the most likely candidate to receive this recognition as a medical device. With their recent funding I suspect that the manufacturer is underway with the project and should have things turned around by the new year. Sucks it's that long but based on what I can gather that would be a minimum. But a prototype could be sent for approval early. I do find that the potential for competitors will be great, however with them a large market to fight over. Many of the use case scenarios for MYDX are in recently approved legislation. This'll make the process slower than a typical application. When it's all said and done MYDX should take home a nice slice of the pie. Having formulas that are constantly being adjusted to meet consumers demand is a great idea and I believe this to be the more valuable aspects of the MYDX business proposition for new clients.
They are certainly capable of doing this however there is potential for another competitor to have begun to develop their own. If MYDX is unable to obtain first mover advantage they could be left in the dust. That being said until another similar device is approved MYDX remains the most likely candidate to receive this recognition as a medical device. With their recent funding I suspect that the manufacturer is underway with the project and should have things turned around by the new year. Sucks it's that long but based on what I can gather that would be a minimum. But a prototype could be sent for approval early. I do find that the potential for competitors will be great, however with them a large market to fight over. Many of the use case scenarios for MYDX are in recently approved legislation. This'll make the process slower than a typical application. When it's all said and done MYDX should take home a nice slice of the pie. Having formulas that are constantly being adjusted to meet consumers demand is a great idea and I believe this to be the more valuable aspects of the MYDX business proposition for new clients.
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