The U.S. Food and Drug Administration (FDA) has approved the use of the first digital birth control app in the United States.
The app is called "Natural Cycles." It consists of a special temperature monitoring device and a high-sensitivity basal thermometer used for measuring minute changes in a woman's temperature. Natural Cycles is the first medical device of its kind the FDA has allowed to be sold in the United States.
The app, which was developed by the Swedish company, Natural Choices, is a more effective version of the hallowed rhythm method of natural birth control.
The FDA noted research confirming Natural cycles appears to be as good at preventing pregnancy as other contraceptive methods, including condoms. It said clinical studies about the app it evaluated shows that fewer than two women out of 100 who used the app perfectly become pregnant. One of these studies involved 15,570 women that used Natural Cycles for at least eight months.
More specifically, the app's failure rate at preventing pregnancy when used perfectly was only 1.8 percent. On the other hand, its typical failure rate is 6.5 percent. This higher figure is due to women having unprotected sex on days when they're predicted to be fertile, and if they have sex on days the app erroneously predicts them to be non-fertile.
FDA said these failure rates are comparable to, or even superior, to those of other contraceptives, including condoms, the most popular form of contraception among men.
Natural Choices said more than 600,000 women in 160 countries have subscribed to the app. Three-quarters of the app's subscribers use it as a contraceptive method. The app's subscription fee outside the USA is $80 for an annual subscription or $10 monthly,
Natural Cycles uses a specially developed algorithm to predict where women are in their monthly menstrual cycle. This information allows women to decide if they'll have sex and if their sex will take place with or without protection (such as a condom for their partner).
The algorithm mainly relies on a high-sensitivity thermometer to track minute changes in a user's daily temperature readings. Days marked green in the handy, pocket-sized device are considered non-fertile days (and generally safe for unprotected sex) while days marked red are no-nos for unprotected sex.
A woman takes her temperature each morning, under the tongue, as soon as she wakes up using the special Natural Cycles thermometer. She then enters this information into the app. Calculations made by the apps' algorithm is based on the observation that progesterone warms the female body by up to 0.45 Centigrade in post-ovulation. Based on the temperature readings, the app determines if the user is fertile or not.
