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[superg1] 29/3/2020 14:01

19th Feb RNS

Additionally, we anticipate that Belluscura is likely to receive FDA clearance for their portable oxygen concentrator within the next 90 days. "

So it seems the FDA have issued a widespread authorisation which seems to capture the portable oxygen device.

[superg1] 29/3/2020 13:42

Looking this definition it seems likely the Belluscura kit is now ok to use

Sec. 868.5440 Portable oxygen generator.
(a) Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

(b) Classification. Class II (performance standards).

This Emergency Use Authorization (EUA) is being issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in healthcare settings to treat patients during the Coronavirus Disease 2019 (COVID-19)1 pandemic.

[superg1] 29/3/2020 13:40

in the list

21 CFR 868.5440

Generator, oxygen, portable CAW II

[superg1] 29/3/2020 13:39

It may well be authority has already been issued

I'd have to look up what section the Belluscura kit comes under to determine if it's been authorised

EG

[superg1] 29/3/2020 13:35

Too long uh The decision making has only just stated to come through.

EG Friday the FDA authorised the use of anaesthetic machines to be adapted to use as ventilators.

It's busy time for the FDA. Logic suggest Belluscura will get early authority and at the very least are onto the FDA re their product and the submission already made.

[supertag] 28/3/2020 11:45

Taking far too long to get the FDA Approval given the fact everything was supposed to be fast tracked!

[superg1] 27/3/2020 10:14

It's illiquid, it will get busy when the FDA news drops.

[supertag] 26/3/2020 19:08

Well that was a rubbish day!

[hope67] 26/3/2020 07:18

RNS Lucyd files patent for voice control app

[supertag] 25/3/2020 18:36

Come on FDA!

[eentweedrie] 24/3/2020 18:57

Maybe you need muscles?

[hope67] 24/3/2020 18:46

Worth a listen

[costax1654x] 24/3/2020 16:03

Pump and dump

[tomboyb] 24/3/2020 14:14

...

Big shortage of physical gold -

tried to pick up 5 oz of it.. not available anywhere it seems -

[petersinthemarket] 24/3/2020 12:32

You cannot add anything to a published patent. You need to file a new application which contains something (a novel idea) new.

[superg1] 24/3/2020 11:38

Smithie

You didn't do much research and raised questions where the answers are there to view.

The product has been designed, built and tested.

It only takes minutes to do.

The kit has been through a test phase of usability too. IE can a patient go through user instructions and effectively use it.

That means it has been designed and produced etc.

The next step is FDA approval which is due very shortly and will become news at some point.