The Australian Register of Therapeutic Goods(ARTG) updated 4D medical device license class from IIa to IIb as of 9th Jan. IIa was updated in October last year.
https://www.tga.gov.au/resources/artg/433171
by what I understand, the higher classification, the higher regulatory oversight and the more “harm” they may pose to the user.
Please correct me from here, the IIb class also allows for greater diagnosis or monitoring necessary to sustain life. IIb is used in more of an ICU/emergency care situation, while IIa is for general checkups. This means we could be seeing 4DXs software in more hospital situations?
If anyone with a medical background could provide further implications/description and or corrections, that’d be much appreciated.
Research, page-2224
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