Totally agree, hence the human factor study which RAP engaged that company to perform when the FDA requested additional information for benefit vs risk 8 months into the review and then decline the submission 2 months later.
This is further evidence there were significant clinical data to show safety and efficacy and the decline wasn't based on these 2 points but clearly the 3 point of benefit-risk and there are supporting research that show how inaccurate respiratory disease diagnosis is especially if in the most common situation where just the stethoscope is used.
ResAppDx is a revolutionary medical device which will have major impact on respiratory disease consultation since the stethoscope, that's probably why Europe approved this technology as they are the most advance in telehealth which need digital medical technology.
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