FDA approves app as a form of birth control

Birth Control Method Contraceptive App- Natural Cycles

The app works by asking women to take their temperature when they wake up as part of a daily log in its interface, using the data to help women keep track of when they're ovulating, the article reported.

Natural Cycles uses this temperature as a way to determine fertility. The app had a "perfect use" failure rate of 1.8%, which means that 1.8 women in every 100 who use the app for a year will become pregnant because they have had sexual intercourse on a day when the app predicted they would not be fertile or because their contraceptive method failed when they had intercourse on a fertile day.

But Natural Cycles co-founder Raoul Schewitzl told Business Insider those numbers were expected, because sometimes people don't follow the app's directions exactly. To use Natural Cycles, women are required to take their temperature with a basal thermometer first thing in the morning and enter the information into the app.

The product though has generated controversy in Europe, where women have reported unplanned pregnancies while using it, including a British writer who wrote a first-person account for The Guardian.

"No contraception is 100 percent and unwanted pregnancies are an unfortunate risk with any contraception", the company said at the time.

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Regulators point out that this form of contraception requires careful monitoring, since women basically have to make decisions about refraining from sex or using protection depending on regular readings from the app, which would caution to "use protection" on days they would be more likely to be fertile.

The system Natural Cycles uses is nothing new-women have avoided sex during certain times of the month for centuries, to varying degrees of contraceptive success-but the technology it presents is utterly that of our digital age.

The app displays the message "use protection" on days a woman is likely to be fertile. The typical use failure rate is right on par with the oral pill, which is around 9 percent, according to the Centers for Disease Control.

"But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device". A yearly subscription comes with a high-sensitivity basal thermometer.

The FDA reviewed the Natural Cycles app through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices of a new type. Natural Cycles is headquartered in Sweden and has operations in Germany, Switzerland, the United Kingdom and is establishing a presence in the United States.

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