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Birth control app certified in the EU
August 20, 2017, 1:03 pm

Natural Cycles, a fertility sensing smartphone app, became the first to receive certification as a form of contraception in Europe.

Though there are other fertility cycle tracking apps, most of them do not get the fertility window right. Natural Cycles uses a specially developed algorithm and other factors, including temperature, to determine which days a woman might be fertile.

The mobile health space is growing and according to some estimates about half of the 3.4 billion smartphone and tablet users will have downloaded mobile health apps by 2018. There are hundreds of thousands of health apps already available and more are being added every day. But despite this plethora of medical apps, very few have been approved by respected health bodies, including by the US Federal Drugs Administration (FDA) and its European Counterparts the European Medicines Agency, or by TUV SUD, the Germany-headquartered global independent product certification body.

Natural Cycles received certification from TUV SUD following a lengthy certification process that involved a series of clinical studies to show that the app improved the effectiveness of traditional fertility diagnosing methods. The European Conformity (CE) certification means that the app is now officially considered a medical device for contraception on Europe. Natural Cycles is now looking for similar approval from the United States.

“Our ambition is to have Natural Cycles certified in every country of the world,” says Raoul Scherwitzl, who along with his wife Elina Berglund, founded the company.

Users measure their temperature each morning, logging it into the app. Natural Cycles then uses an algorithm to calculate if the day is green, meaning not fertile, or red, when fertility is likely and using protection is recommended. The Swedish-based company charges $52 for a yearly plan, which includes a thermometer, or $7.80 per month. The company says its clinical studies have shown that the app is effective for contraception, “comparable to the contraceptive pill,” and it has over 300,000 users in 161 countries.


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