Ann: CE Mark Update, page-367

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hyper41

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12/03/20

23:28

Post #: 43461960
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Originally posted by Abdi70: ↑

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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Apologies Abdi you are correct they did final submission at the beginning of January 2019 AND GOT APPROVED in late August so more like 8 months wait for CE approval from final application submission rather than the 6 I quoted

OSL Price at posting: 9.6¢ Sentiment: Buy Disclosure: Held
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