3 ms·
I've seen multiple attempts to get melanoma detectors past the FDA. The last attempt cost millions of dollars on appeals and still ultimately failed. Hopefully
by alasdair_ 9y ago
I've seen multiple attempts to get melanoma detectors past the FDA. The last attempt cost millions of dollars on appeals and still ultimately failed.
Hopefully thia one will do better.
- taneq 9y agoIt seems to me that the FDA should allow the best available option through even if it's not very effective, as long as it's safe and no false claims are made. This would at least allow companies to bootstrap and iterate if their approach works at all.
- jhayward 9y agoI believe FDA criteria is it has to be as good or better than the best available technique, which AFAIK is a detailed exam by a trained dermatologist, possibly using several tools like light sources, magnification, etc.