“We are so excited to finally be able to offer Proov technology to the European market. Our CE approval is testament to Proov’s dedication to bringing safe, accurate, and high quality testing to women everywhere.” – Amy Beckley – MFB Fertility’s founder and CEO.
BOULDER, Colo. (PRWEB)
June 24, 2021
Proov, a science-based hormone testing company and the leader in testing urine for PdG to confirm ovulation, is announcing today that it has received CE marking approval for sales of its patented and patent pending PdG tests in Europe. The new European approval will help Proov address the long-awaited arrival of PdG tests by European consumers.
Prior to commercialization, medical devices such as Proov PdG tests in the European Union were required to undergo a conformity assessment to demonstrate that they met legal requirements to ensure they are safe and perform as intended. A typical assessment involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device. Because it passed its conformity assessment, Proov has been approved to place a CE (Conformité Européenne) mark on its PdG test products, a critical step in bringing its product to Europe.
Proov’s tests are now the first PdG test device to be CE marked for self testing and become widely accessible to a woman, instead of through a medical professional. This is important to give women more direct and seamless access to answers sooner so she can be empowered with critical information about her cycle before she is permitted to seek out medical care, which unfortunately can often take up to a year to schedule.
Proov PdG tests evaluate for the presence of PdG, an analyte of Progesterone produced in urine. Progesterone is a critical hormone produced by the ovary after ovulation. One of the main roles of progesterone is to prepare the uterine lining for implantation. Without enough progesterone after ovulation, it can be more difficult for implantation to occur. However, prior to Proov – the only FDA-Cleared and now CE-marked for self-testing urine PdG test – no diagnostic test could assess ovulation quality to determine if a woman produced enough progesterone to confirm a healthy ovulation, giving her the best chance at successful conception.
MFB Fertility’s founder and CEO, Amy Beckley adds “We are so excited to finally be able to offer Proov technology to the European market. Our CE approval is testament to Proov’s dedication to bringing safe, accurate, and high quality testing to women everywhere.”
Proov Tests are currently available at Amazon.co.uk and proovtest.com and will soon expand to additional e-tailers. They are non-invasive and cleared for home use, making fertility diagnostics more accessible to patients.
To learn more about Proov®, visit proovtest.com, and to learn more about PdG and the benefits of tracking it, visit https://proovtest.com/pages/faq.
About MFB Fertility, Inc.
MFB Fertility, Inc. developed Proov®, an at-home PdG test that measures the presence of progesterone metabolite PdG in urine to help a woman confirm that she has ovulated successfully. Originally co-founded in Boulder, Colo. by two women who both struggled to conceive, MFB Fertility was created to empower women to know more about their menstrual cycles, ovulation health, and PdG levels. Don’t just predict ovulation, Proov it! For more information, please visit https://proovtest.com/.
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