Fertility App Receives Clinical Approval as a Contraceptive

Natural Cycles,Natural Cycles Feb 2017 cropped the fertility tracking app that uses a smart algorithm to help women pinpoint their fertility, has become the world’s first app to be approved specifically for contraception.

Certification organisation Tüv Süd has approved Natural Cycles as a class IIb medical device intended to be used for contraception. This means in effect that the app carries the same status as a clinically-tested, regulatory-approved contraception to use alongside condoms, The Pill and IUDs.

The app was created by husband and wife team Dr Raoul Scherwitzl and Dr Elina Berglund. Dr Elina Berglund is one of the scientists who discovered the Higgs Boson which led to the Nobel Prize in 2013. It’s a hormone- and chemical-free birth control alternative and, in 2016, a clinical study showed that the app was as effective as the pill.

In 2016, the University of Copenhagen released the results of a clinical study, the largest of its kind, involving 1m women, which confirmed a link between hormonal contraceptives and depression. An estimated 3.5m women in the UK use hormonal contraception.

Natural Cycles works by recording the user’s daily temperature. A smart algorithm then determines whether the woman is fertile on that day so that she accurately knows if and when to have protected intercourse, or try for a baby. The app is currently used by over 150,000 women in 161 countries.

“Women around the world are interested in exploring effective non-hormonal, non-invasive forms of contraception, and now they have a new, clinically verified and regulatory approved option to choose from, said Natural Cycles CTO and co-founder, Dr Elina Berglund. “Our high quality clinical studies, together with the required regulatory approvals, means we can provide women everywhere with a new option for contraception. Natural Cycles allow women to better understand their bodies so they can make choices that are right for them.”

The Natural Cycles app joins a range of medical products that have been clinically tested and regulatory approved to achieve a IIb classification, such as intensive care monitoring and alarm devices, anaesthesia machines, blood pumps for heart-lung machines and blood bags, to name a few.