Video: EBR Systems’ (ASX:EBR) pacemaker the size of a grain of rice, page-10

I don’t think EBR’s Andrew Shute would mind me sharing part of his reply to my email on 20 November 2023.

[ The only change in our FDA approval pathway is related to the delay in submission of the final module that we released to the ASX last Tuesday. This is isolated to a testing delay with one of our vendors. Specifically, this is an abrasion test that is performed on the cable that connects the Transmitter to the Battery. We had underestimated both the start date for the test, and the duration of the testing period. We have indicated final submission will occur during Q3 2024, but our team will continue to try to get the submission in as early as possible. ]

We know that an expert advisor brought this issue to management’s attention. We also know EBR appointed an ex-Medtronic senior manager, as their scientific advisor, who might know a thing or two about submitting FDA submissions for medical devices in the cardiac space.

Fingers crossed!