Fact is if FDA gave more leeway for free market experimental use of medical devices with simultaneous standard practice confirmation it wouldn’t be so prohibitly expensive to prove ( or disprove) a device’s value and risky foreign markets wouldn’t be the only route for under funded start ups.
Political bureaucracy prevents potentially patient benefiting technology from coming into play unless they have extremely deep pockets. There is a need for validation but validation shouldn’t be suffocating
If you believe the product is legit then your frustration should be directed at your US Rep. and Senators, not the cash strapped innovators. Use this as an example with them as to why health care costs are thru the roof.
May not help gthp but it’s a good point to make with elected officials
If you are going to whine do so at the right target!!
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