Revolutionizing Birth Control - femSense Takes the First Steps Toward Approval.
The femSense Ovulation Tracker has been proven to be 99.73% accurate. A great start to the process of approval for femSense as a form of contraception
We have always had confidence in the accuracy and precision of the femSense system, it has been tried and tested for several years now and our user feedback tells us that women are reliably tracking their menstrual cycles and measuring their ovulation. We already have over 14,000 femSense babies born to women who used femSense to identify their ovulation so that they could plan a pregnancy. Thousands of other women use femSense to make sense of their fertility – so that they know when their period is due, when they are most fertile and need to use precautions to prevent pregnancy or when to expect cramps or cravings.
The latest version of our Ovulation Tracker app includes an optional feature that allows you to log your symptoms every day. This data is used by our algorithm to predict when you are likely to ovulate – with 99% accuracy! You can then use this information to plan a pregnancy – either by using a method of birth control such as FemCap or ParaGard or by continuing with sexual activity without protection.
Now we have submitted our results for approval by the UK Medicines & Healthcare Products Regulatory Agency (MHRA). This process involves submitting clinical data from more than 1000 women who have used the FemSense app over a two-year period, with an average accuracy level of 99.73%.
Getting independent confirmation that femSense works is however always a boost and an acknowledgement that we can help women take control of their fertility. Just last year a clinical study with the medical university in Graz proved the accuracy of the sensor patch and now an independent Swiss statistics institute has confirmed that femSense is 99.73% accurate when predicting ovulation.
The results were published in the leading peer-reviewed journal Obstetrics & Gynecology, one of the top journals in ob/gyn, and concluded that: "femSense is a reliable method for monitoring ovulation."
What They Said
“A woman’s fertile days can be very reliably defined by femSense”, says Novustat Managing Director Dr. Robert Grünwald. The independent statistics service providers specialize in supporting approval procedures for medical products and digital health applications: “We carried out the evaluations and quality control for femSense. The data was submitted in a very sound, well-structured format, so we were able to carry out the evaluations to a high scientific standard.” The independent statistics institute Novustat was able to determine an overwhelming accuracy of 99.73% for regular cycles.
This news is a huge milestone for femSense and we are delighted to be able to share this with you.
What That Means For femSense
What does this mean for the future of femSense? These statistics help pave the way for femSense to become a hormone-free contraceptive product. At present two-thirds of femSense customers use our product to plan a pregnancy but when used as a fertility awareness tool femSense can also help to prevent a pregnancy. We have already started the procedure to get approval as a method of birth control.
femSense For Birth Control
In 2021 a cycle-tracking app was FDA-cleared as a contraceptive in the US. We think femSense has much better prerequisites for approval as a form of birth control because we offer even more. femSense is an app and a wearable! The femSense system is a medically certified product consisting of a wearable sensor patch and the supporting cycle tracking app. Based on the well-known temperature method trusted by generations of women to plan or prevent a pregnancy femSense continuously measures the body temperature during a woman’s most fertile days until it has measured and confirmed ovulation has occurred. This combination of 99.73% accurate app predictions and the very precise temperature sensor patch is why women will choose femSense as their preferred choice of hormone-free contraception in the future.
The 99.73% accuracy result is confirmation that our system works. Our objective will remain the same: to narrow down the fertile window and identify the time of ovulation. We want women to use femSense to make sense of their fertility. Whether that is to plan or prevent pregnancy or just track their cycle. We will do all the hard work of measuring and analyzing; all the user has to do is wear the patch during her fertile window. The femSense app will let her know when she ovulated and when she is fertile.