The first mobile medical application to be used as a method of contraception has been granted marketing approval by the US Food and Drug Administration (FDA). Women who rely on Natural Cycles as a pregnancy prevention method would have to use a special thermometer to take their "basal body temperature"-i.e., the body's temperature when it's still at rest, upon waking up-in order to assess what part of her ovulation cycle she is in". It's called Natural Cycles, and it uses a woman's basal body temperatures to determine fertility (via Stat).
FDA said the app had a failure rate of 1.8% for women who became pregnant after having sex on a day when the app predicted they would not be fertile, or whose contraceptive method failed when they had sex on a fertile day.
"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.
Using data like daily body temperature and monthly menstrual cycle tracking, the app is said to have a fail rate of almost 2% for "perfect use", and a fail rate of 6% for "typical use", not unlike barrier methods and the pill.
According to the FDA, clinical studies involving 15,570 women showed that the app has a flawless use failure rate of 1.8 percent, which means 1.8 in 100 women who use the app for one year will become pregnant because they 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.
A number of alarms have been raised about the app resulting in unintended pregnancies in a recent Guardian report whose author reported becoming pregnant while using it. 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.
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"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 algorithm identifies and displays "green" or "red" days, green for not fertile and red for fertile.
FDA approved the Natural Cycles app through the de novo premarket review pathway for new low- to moderate-risk devices.
Also Friday, the FDA approved the first vaginal ring contraceptive that can be used for an entire year. Even though Natural Cycles claims to be an effective contraceptive, it's not 100 percent fool-proof when used by itself.
Last year, FDA released a Digital Health Innovation Action Plan for regulating digital health technologies like the Natural Cycles app.