Maybe people aren't getting diagnosed at very high rates? That would be a reasonable justification for deployment with somewhat less than perfect accuracy. Anyone have any insight?
In this case, they might weigh: * How many new cases are caught by expanding access to specialist tools * What fail safes exist in current course of care — how does a false negative result in a worse outcome for a patient than if they had had no diagnostic at all * etc.
The summary of their decision is public record, but not the detailed analysis.
If you can show a statistically better chance of a good outcome with a small chance of significantly worse outcome, the FDA will often approve.
The medical risk is that people will forgo other screening for 12 months when given a negative result. The cost of additional screening for false positives is the other big downside (this is all the machine does, recommend a specialist visit or to rescreen in a year).
Really? Standard advice is 1/yr for both.