Hi @MolskisPabrai,
I looked into this directly with Revenio, as one always has to be careful with these FDA interpretations. I received some sensible answers, which I’ve tried to put into “plain language” here without the fancier terms. Hopefully, I’ve understood the details correctly myself and haven’t oversimplified them too much. If I were to summarize, it’s a good thing, but not a silver bullet by any means.
The company mentioned that it had already used this opportunity previously when obtaining marketing authorization for the IC200 tonometer’s new feature, Quick Measure. This was possible even before this new relaxation regarding the use of “real-world” data because the data was traceable (data collected in connection with a clinical trial). In the future, Revenio could use clinical data, for example, in connection with post-market surveillance or to demonstrate the effectiveness of HOME2 in the care pathway—or something similar.
According to the company, this won’t necessarily have an impact on marketing authorizations. This is because data is primarily only collected from measurements, and the software doesn’t systematically collect data from, for example, corresponding GAT measurements or CCT. So, there needs to be a reference in the study, unless I misunderstood.
The company could likely better utilize this relaxation, for example, in connection with the RedCad marketing authorization. However, this requires that care practices and device usage be consistent, for example, in the EU (cf. USA). We could strengthen our data and potential clinical evidence with device data already accumulated in the EU and other countries.
The US vs. EU comparison won’t be easy here because, for example, disease classifications are different. Furthermore, the guidelines governing software and clinical validation remain in effect for that application. Additionally, the analysis must be reproducible and the origin of the data verifiable, even though the patient does not need to be identifiable.
Demonstrating efficacy this way specifically might still not be realistic, but this will certainly be useful in demonstrating safety and usability, usage rates, and the like. FDA reviewers apparently also get more flexibility, as the announcement stated that discretion can be used on an “application by application” basis. However, some general guidance is forthcoming, after which a clearer policy on the matter will start to form.
The company did not comment on the potential data of other companies or their lack thereof.