Thank you for your analysis and feedback on this as someone with experience and working knowledge in the industry.
I liked your feedback that (and was hoping this change is favourable for 4DX):
“The classification change to IIb to me indicates there is a strong diagnostic value that can now be proven and influences the indications for use. The device is no longer just providing general information to a clinician, but giving guidance on disease state in some form that will allow a diagnostic conclusion upon which to base treatment.”
@strangelogic Would you have any insights on this higher IIb classification on potential future Australian Medicare reimbursement (MBS) value? Given the implied higher value information provided by our product as IIb, could this mean a stronger case for being assigned a higher Medicare rebate (if attained)? If so, this indicates a team taking all the right and patient steps to secure more commercial value for the company and its ultimate users.
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