Hi WS
I think the bar for the FDA will be to show that Resapps device for diagnosing the 5 respiratory illnesses being considered is the same as or better than a doctor with a stethoscope.
So around the 70% mark ought to be enough.
Note there is some evidence from studies in US hospitals that the sensitivity of pneumonia diagnosis is in the 40% to 60% range, so 70% for Resapp should be sufficient.
Top-line US results, page-128
Currently unlisted. Proposed listing date: 4 SEPTEMBER 2024 #
