Morning fellow RAPpers
Just thought I'd let you know something that I found out during one of my phone conversations recently with management. ResAppDx-EU is an extension of the existing CE Mark approval (as stated in the announcement) meaning it did not require a separate submission for CE clearance. You know I thought it was a bit odd that they didn't announce lodgment for adults and thought that it was something that was granted way too quickly considering how long it took for the children CE Mark to be granted.
"This CE Mark approval is
an
extension of the
existing CE Mark approval for ResAppDx-EU, adding the ability to test adults for lower respiratory tract disease, pneumonia, asthma exacerbation and chronic obstructive pulmonary disease (COPD) exacerbation. CE Mark certification indicates that ResAppDx-EU
version 2 meets the essential requirements of all the applicable European regulations as a class IIa medical device and allows for its sale throughout the European Economic Area."
This works in much the same way as when a new phone comes out the company will create a new version or update rather than applying for a whole new submission again. The turnaround time for this is extremely fast.... Now they have
version 3 our technology can pick up sounds of ones snoring to distinguish whether or not they have sleep apnea... It will be very interesting if we can add this as an extension also rather than submitting an entirely new submission. Clearance would be granted swiftly if this is the case, within just a few months or less rather than waiting 9 months for a totally new submission to be cleared again as it is based on the same software, using the same methods that is - using a smartphones speakers to pick up the sound and our machine learning algorithms analysing the information from those sounds to produce an accurate result... This process might also work for the FDA if the FDA Grants the approval for our de Novo application smart software. If this is the case it should then be easier to be granted clearance for any other extensions to the software such as coughing signals for adults etc as no new submission would be required.
I will endeavour to discover more detail around this when I attend the next TechKnow meeting on the 22nd of this month... For those of you who wish to attend here is the link:
https://www.techknowinvestroadshow.com.au/Cheers
Red bar
