The Food and Drug Administration (FDA) has approved the first app billing itself as "digital contraception" to market in the USA despite concerns from officials in two countries about unwanted pregnancies as a result of the app's use.
Natural Cycles claims the app has been 93 percent effective at preventing unwanted pregnancies.
Natural Cycles reports which days a woman is most fertile based on daily body temperature readings and menstrual cycle information. The company stressed that no form of birth control is considered to be 100 percent effective at preventing pregnancy.
Clinical studies to evaluate the effectiveness of Natural Cycles for use in contraception involved 15,570 women who used the app for an average of eight months.More news: Indian human space mission to create 15,000 jobs
To use the app, women take their temperature each day when they wake up and enter the reading into the app.
To be clear, using this app requires user effort, too.
The sensitive thermometer can detect a minor rise in temperature of approximately half of one degree Fahrenheit (or 0.28 in Celsius) around the time of ovulation. 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. Women using the app should abstain from sex or use protection (such as a condom) when they see "fertile day" displayed on the app, typically 4 or 5 days a month.
However, the agency added, "women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device". Ideal use would mean using the app exactly as intended, tracking every day and only having sex on "green days".More news: Brexit Britain: Unemployment Lowest in 40 Years, Wages Up, EU Migrants Down
"Based on the strength of our clinical data, we are delighted that the FDA granted De Novo classification for Natural Cycles and look forward to working together with healthcare professionals to offer a digital form of birth control to women in the USA", said Elina Berglund, PhD, CTO and co-founder, Natural Cycles.
The app was approved a year ago by the European Medicines Agency, the European equivalent of the FDA. Natural Cycles is headquartered in Sweden and has operations in Germany, Switzerland, the United Kingdom and is establishing a presence in the United States. 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 commended the FDA's decision on Twitter on Friday, saying the company was "delighted" to win FDA approval.More news: Turkey willing to talk with USA as equals over tariffs and pastor