I was able to search nearly all the announcements back to about 2005 on a pdf I created. The only thing I came up with is that
The Strong Heart Study used the SphygmoCor® system which measures central blood pressure without the need to insert an invasive catheter into the heart. The SphygmoCor® is unique as it is the only FDA approved and validated method to measure central blood pressure without invasion.
Irena Cosic is a Professor of Biomedical Engineering and Head of School of Electrical and Computer Engineering at RMIT University and is a Research Director of the NHMRC Centre of Excellence. She has published over 160 papers
and holds international patents protected in USA, Europe, Japan and Australia.
Plus many other references to the number of ECG's performed in the USA.
So the radial pulse wave tech is apparently the only one approved by the FDA.
And the US is firmly in the minds of the Executive.
Irena Cosic's profile is interesting as it shows some expertise in dealing with international regulatory authorities. Certainly credible. The same could probably be said about Dr Alexander Taube who also sits on the SAC at IMI
So from this while I cannot find specific reference. it would be extraordinary to say the least if IMI have not put the wheels in motion with the FDA.
I would surmise that they most probably have.
Cheers
BW
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