CDX 0.00% 6.0¢ cardiex limited

Ann: CardieX receives FDA 510(k) Clearance for CONNEQT Pulse, page-43

  1. 2,281 Posts.
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    How good is Toni Hofhine.
    Our ATCOR President simply has that unique ability to make things happen.

    https://hotcopper.com.au/data/attachments/5228/5228249-32686178f7272fe86d27fdbfa236874a.jpg

    I'm sure we all recognised that Toni was the contact for the FDA submission.
    And, we had employed the services of a 3rd party, Heyer Regulatory Services, to get the application through.
    Our internal regulatory affairs manager "left" the business in November last year.

    https://hotcopper.com.au/data/attachments/5228/5228270-251aa1a659e86ffce8553cff0fa0a52f.jpg

    Sheila Hemeon-Heyer looks very impressive, and if Toni was involved in getting her working on our business, thank you !

    https://hotcopper.com.au/data/attachments/5228/5228291-74bdc72bb7b51e5cfc16bf5131915486.jpg
    https://hotcopper.com.au/data/attachments/5228/5228307-934204fb9ab38717a6e67fba9bb935e4.jpg

    Whatever the background story here, it is brilliant to now have clearance for Pulse, and have Toni & Sheila running the regulatory approval process ( if that is indeed the case ).
    AND ... as a LTH, I look towards the FDA submission for the CONNEQT Band with renewed confidence.

 
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