Nice find @Jimmmmy1 - and hot off the press too!
Looks like our tech was reclassified to Class IIa on 5 Oct 2023:
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=424192&agid=%28PrintDetailsPublic%29&actionid=1
And now to Class IIIb on 9 Jan 2024:
https://www.ebs.tga.gov.au/servlet/xmlmillr6?dbid=ebs/PublicHTML/pdfStore.nsf&docid=433171&agid=%28PrintDetailsPublic%29&actionid=1
You can see that the intended purpose has been updated by 4DX - wonder if this partly explains why the company has requested reclassification? Noting that (re)classification is the responsibility of the company and the intended purpose is a main consideration when classifying.
Whilst Class IIb is a classification the TGA seems to be moderate to higher risk, according to the TGA classification rules, it also indicates the device may be used to diagnose and monitor more serious conditions that pose a high public health risk (which seems favourable for 4DX, compared to the lower classifications).
AF mentioned in December last year that the team is doing everything it can to achieve Australian Medicare reimbursement. Is this part of them getting all their ducks in line for this?
Research, page-2226
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