FDA Approves First Mobile App for Use in Preventing Pregnancy

Now a mobile app acts as a contraceptive

The app costs $10 per month, or is $80 for an annual subscription, which includes an oral basal thermometer (which users take their temperatures with each morning to determine fertility).

"But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device", she added.

The Food and Drug Administration (FDA) has approved the marketing of the first app to prevent pregnancy.

The algorithm identifies and displays "green" or "red" days, green for not fertile and red for 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 has been developed by Swedish-based NaturalCycles Nordic AB, to help women who follow widely used fertility awareness method to prevent pregnancies.

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The company said the app had a "typical use" failure rate of 6.5 percent, which accounted for women sometimes not using the app correctly.

The app tells users when they are more likely to be fertile and should abstain from sex or use protection if they don't want to get pregnant. The flawless use rate is the percentage of women who would become pregnant because of intercourse on a day the app predicted they would not be fertile, or their contraceptive method failed during intercourse on a fertile day. With those kinds of failure rates for some of the most commonly used birth control methods, the failure rate for Natural Cycles doesn't seem too bad. Or those now using birth control or hormonal treatments that inhibit ovulation.

FDA approved the Natural Cycles app through the de novo premarket review pathway for new low- to moderate-risk devices. It was developed by a physicist couple, Elina Berglund and Raoul Scherwitzl, who sought an effective method of natural contraception.

"We are aware of a significant number of women in the United States looking for alternative, effective natural methods of birth control", said Juan Acuna, M.D., Associate Professor of OBGYN, Department Chair at Florida International University College of Medicine. This action also creates a new regulatory classification, which means that subsequent devices with the same intended use may go through the FDA's 510 (k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. Natural Cycles does not provide protection against sexually transmitted infections.

In clinical trials, about two to four women out of 100 women became pregnant during the first year they use Annovera.

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