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How the FDA process is biased against new technology
- Turing_Machine 11y agoHmm... the MelaFind thing doesn't sound risk-free to me. If it's approved, there are two ways that could go wrong: 1) Doesn't identify a real cancer (risk is obvious) 2) Falsely identifies a non-cancerous mole as cancerous (exposes patients to unnecessary surgery, which always carries some risk, even with something as minor as a typical mole removal). In both of those cases there's going to be a specific, identifiable dead or injured patient (or family of same) raising hell, creating a PR black eye for the FDA. If the software isn't approved, people will probably also die, but they won't be as identifiable, at least not nearly as easily. They likely won't even know. I'm not saying that this is a good situation ('cause it isn't), but that's how things are. I don't think they're biased against technology, I think they're biased against risk (specifically, risk that might reflect badly on the FDA).