Ann: Update on US FDA De Novo Classification Request, page-217

RAP's algorithmic determinations, as with the stethoscope, are indicative only. I've never been to a doctor for respiratory issues where the diagnosis has been confirmed by a stethoscope only. The doctor post examination requests bloods, x-rays and imaging before a diagnosis is completed. I find it hard to accept that the FDA would place a greater responsibility on this tech than that of a doctor & their stethoscope. This is a big blow for telehealth generally.