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.
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