How good is Toni Hofhine.
Our ATCOR President simply has that unique ability to make things happen.
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.
Sheila Hemeon-Heyer looks very impressive, and if Toni was involved in getting her working on our business, thank you !
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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- Ann: CardieX receives FDA 510(k) Clearance for CONNEQT Pulse
Ann: CardieX receives FDA 510(k) Clearance for CONNEQT Pulse, page-43
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