PRVB, for what its worth, the answer to your imbedded (and minor I suspect) question re; how Diamics got approval so quickly, and the e2's approval years ago, etc...
FDA looks at 2 things in any study: (i) Safety, and (ii) efficacy. They do NOT look at market / business viability.
A "better" test than the pap based on this criteria would be to do colposcopy very frequetly (monthly, weekly, etc.). It would be safe (not cause harm - likely) and would certainly catch the disease in its earliest stage.
But its not practical; we can't afford it (systemically), its inconvenient, there aren't enough resources, its painful, etc.
To prove a product is safe and efficacious is typically easy compared to collecting the information required to answer these other questions. This is the challenge with devices vs. pharma within the FDA processes.
The MD "satisfaction" study is a good example of trying to provide statistically-relevant information on the device beyond the FDA's litmus test. And others are needed, like what's it cost to operationalize the device? Does it slow down the office / # of patients moving thru an MD's day?
These "other" points of investigation are what cause a 200 year delay in air-conditioning getting from patent to market.
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