Another thought I had while reading the US CMS Medicare report...

Another thought I had while reading the US CMS Medicare report for EPI ProColon (link is first post in this thread) was that the CMS seem to like to see substantial proof of test statistics demonstrated in a real world setting.

The US system, in which a CLIA labs endorses medical devices for sale without the need for TGA approval, allows for real world testing, thus establishing additional data in the process which can be used for both TGA and CMS approvals in the future.

The Epi ProColon report, dated Jan 2021, states that TGA approval is required prior to any CMS Medicare reimbursement approval, but the former does not guarantee the latter.