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Wednesday, 12/05/2018 2:03:11 AM

Wednesday, December 05, 2018 2:03:11 AM

Post# of 106832
It is amazing that the FDA has such heartburn over stem cell research and treatment. I just finished watching The Bleeding Edge documentary on Netflix which highlights the FDA's approval of nearly every single 510(K) medical device application.

Most people probably believe when they get a medical device – be it a pacemaker or a joint – that those medical devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them – but for most moderate and high-risk devices that is not the case. For the 510(K) pathway all the manufacturer needs to demonstrate is that their device is ‘substantially equivalent’ – is the regulatory term – to another (predicate) device that’s already on the market. Michael Carome – Director, Public Citizen Health Research Group

How the heck does the FDA have the balls to put millions at serious health risk all the while hammering researchers and physicians who are working with a patient and the patients own cells? WTF

Down with Opioids
Down with moderate and high-risk devices

Go $USRM

My post are for entertainment purpose only