elizabeth_jensen_bauer's profile

2 Messages


140 Points

Tuesday, November 22nd, 2016 3:11 PM


I know that your company sells the same monitor in Europe, programmed for pregnancy avoidance, as Persona. Could you please tell me why this product is not sold in the U.S.? I know that a partial answer is "it's not FDA approved", but I'd really like to know why not: has the FDA refused to approve it? Do they categorically refuse to approve such products? Is the process of approval too difficult? (And, if so, exactly how difficult is it specifically, relative to the approval process in Europe?) Or has the company simply never wished to attempt approval?

thank you!
Brand User

597 Messages


6.4K Points

7 years ago

Hi Elizabeth.  The Persona Contraceptive Monitor sold in Europe is a completely different product to the Fertility Monitor.  The Fertility Monitor is not suitable for use as a contraceptive.  It is simply a business decision not to offer the Persona Monitor in the USA and therefore we have not needed to apply for approval.