Natural Cycles App Achieves Medical Device Regulation

Natural CyclesNatural Cycles, the fertility app that has been shown in recent clinical studies to be as effective as the contraceptive pill at preventing pregnancies, has become the first health app for women to be regulated as a medical device.

Results of the clinical study demonstrating the effectiveness of Natural Cycles as a natural birth control has recently been published in the peer-reviewed European Journal of Contraception & Reproductive Health Care.

Health apps are an important part of daily life for many women which means the information provided by them impacts their health and well-being. As more health apps for women come close to performing tasks that fall under the definition of a medical device there are greater calls for them to be regulated as such.

“Regulation is a good thing in the app and healthcare technology space”, said Dr Raoul Scherwitzl, co-founder and chief executive, of Natural Cycles. “Natural Cycles is backed up by well-researched, large-scale clinical studies and, being CE-marked and ISO certified, means that the quality of our product and the safety of our users is at the heart of every decision we make. We know we are dealing with women’s lives here and we take that very seriously.”

Launched in 2014 and headquartered in Stockholm, Sweden, Natural Cycles has over 100,000 active users in 161 countries. The company recently raised $6m (£4.5m) funding to aid international expansion and conduct new clinical studies, and donated $25m worth of free subscriptions to women in Brazil to help fight the Zika virus.

Natural Cycles started the process to get the app regulated as a medical device when it launched in 2014. “We made user safety our number one priority,” said Raoul, “but it took a while for us to be regulated as software apps are designed and developed very differently from hardware devices, which means that sometimes it’s very difficult to adapt to the regulations.”