Contraception app Natural Cycles gets go-ahead from Health Canada

Natural Cycles has secured the approval from Health Canada to market and sell its app as a form of birth control.

Previously sold in Canada as a fertility tracker, the Natural Cycles app is the first app of its kind to obtain a Class II Medical Device License from Health Canada, according to its developers.

The app aims to help women plan or prevent a pregnancy “naturally”, by using an algorithm that analyses daily hormone-driven temperature changes to confirm if the user is fertile.

In order to receive their daily fertility status, users have to take their body temperature or sync temperature data from a wearable device.

Dr Elina Berglund Scherwitzl, co-founder and CEO of Natural Cycles, said: “Our mission has always been to reach as many women as possible and with our latest regulatory clearance from Health Canada, our app is now accessible to more than 380 million women globally.

“We hear from our users every day that Natural Cycles has changed their lives and we are excited to bring another birth control option to Canada and help more Canadians prevent or plan pregnancy naturally.”

Dr Raoul Scherwitzl, co-founder and CEO, added: “As the need for more contraceptive options increases worldwide, we will continue to obtain the proper regulatory approvals in new markets while also improving our product and making Natural Cycles more accessible in existing markets.

“While our team was submitting for the Health Canada license, we were simultaneously working with US and European regulators to get clearance on our Apple Watch integration and with American insurance companies to help them comply with federal mandates to cover Natural Cycles in full.”

In September, Natural Cycles received 510(k) clearance from the US Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch.

The app received clearance to be marketed as birth control in 2018 through the FDA’s de novo premarket review pathway and was certified in the European Union in 2017. In the UK, however, the NHS does not recommend the app as a birth control method.

While Natural Cycles claims a typical use effectiveness rate of 93 per cent and a perfect use effectiveness of 98 per cent, experts have warned that the body’s basal temperature must be taken carefully for the algorithm to be correct and for the app’s result to be effective.