Re: [ANN] ⚡ HEALTH MONITOR⚡ | Crowdinvesting in innovative medical diagnostic
I dont think FDA approval is needed, its 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.
Yes this is really needed, if not they will be sued by everyone in the US
