Sorry hyper41,
don't know what you're smoking.
RAP made their one and only submission as a class 2 device (along with the PMA) in Jan2019.
After obtaining iso 13485 and the following:
"The CE Mark approval was supported by data collected in ResApp’s Breath Easy paediatric clinical
study. The Breath Easy study was a double-blind, prospective study which evaluated the efficacy
of ResApp’s cough-based diagnosis algorithms in diagnosing acute respiratory disease in children.
The study collected data from 585 patients and demonstrated that ResApp’s algorithms had
excellent agreement with a clinical diagnosis. Results from the study were recently published in
the peer-reviewed journal Respiratory Research."
Oncosil has no hope.
It's very clear in the CE mark directives that for an application to succeed you must first conduct a controlled scientific trial.
Sorry hyper41, don't know what you're smoking. RAP made their...
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