The 10 week period was for Richard to meet with FDA to determine which regulatory pathway to undertake.
Our hopes are on getting a 'breakthrough device' designation which now includes automatic Medicare coverage via a new MCIT rule. However last month it was announced the MCIT rule was going to be delayed by 60days to get more public feedback. The MCIT rule has bipartisan support in Congress though so it is expected to come into effect.
This week is the final week, if no news comes - I will be very disappointed & the SP will take a hit.
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