Don't get too carried away. The CE Mark approval as stated in...

Don't get too carried away. The CE Mark approval as stated in the ASX release was: "[Supported by its technological and scientific platform,] Medibio’s product enables clinicians and individuals to evaluate stress-level phenotypes, combined with dimensional circadian heart-sleep biometrics and physiological biometrics.

It does not say to 'diagnose'. So it is not approved as a diagnostic.

It is not approved to evaluate or diagnose PTSD, major depressive disorder (MDD), GAD (general anxiety disorder) or other pathologies.

Its label claims appear  from the wording restricted to non-medical use.

In effect, its a CE Mark for another stress test for 'clinicians and individuals'. Hardly seems to me to carry much weight as a tool capable of obtaining health insurance reimbursement as a clinical item. Where's the great commercial potential for this evaluator? It's going to take a lot of marketing dollars and resources. Remember, MEB's had a stress evaluator protocol available here for a couple of years. Where's the revenue from that?

Given the CE Mark qualification, is the proposed FDA submission for a depression diagnostic or a stress level phenotype evaluator?

Other than its potential as a diagnostic for major depressive disorder, there is no clinical evidence to support any claims for MEB's technology platform as a diagnostic for PTSD, GAD or other pathologies.

While gaining the CE Mark demonstrates certain rigour for this application, no inference can confidently be drawn the same will apply to medical applications such as a diagnostic for MDD.

It seems another wait to gaining approval as a diagnostic where it may have significant commercial potential. Don't hold your breath.