3 ms·
I'm kind of perplexed why Apple needs FDA approval for their watch to measure blood oxygen, yet Theranos can develop a completely novel blood testing technique
by josephpmay 12y ago
I'm kind of perplexed why Apple needs FDA approval for their watch to measure blood oxygen, yet Theranos can develop a completely novel blood testing technique whose results could impact major medical decisions without having to conduct a single study.
(note that I'm not saying that Theranos hasn't conducted studies, rather the FDA doesn't require any)
- toomuchtodo 12y agoFDA testing regulations loophole.
- Alleluja 12y agoEx-CDC Director and Kissinger on Board of Directors Loophole. And no, we don't have corruption in the US
- jacquesm 12y ago'device' versus 'service'
- ealexhudson 12y agoWhich implies Theranos only uses standard devices for their service, then?
- gojomo 12y agoStandard devices, or proprietary devices developed (and kept) in-house. The New Yorker profile suggests that FDA device approval only becomes necessary when devices are sold.
- marincounty 12y agoThat is quite a loophole! If these blood tests are proved to be inaccurate, the lawsuits will be a plenty? I have followed her career. In every Interview, she talks about the huge about of funding the company has received. Why not perform double blind studies? Blood is sent to Quest Labs. Blood is sent to her companies machines. The results are collated by a third party. It seems like one of the easier studies to set up? It seems like a cheap way of proving her machine works as described? Plus, the company Lawyers could sleep at night?
- jacquesm 12y agoWhat if they did just that, then chose to not publish the results? That would be a really good strategy, you play your cards when you need to, on your terms rather than on the terms of your competitors.
- marze 12y agoIt is because the FDA's prime mission is to protect the drug manufacturers from any non-drug competition.