Yes, it’s true. Step further in digital healthcare innovation.
Natural Cycles app was created in Stockholm by Elina Berglund and Raoul Scherwitz. It is CE marked in Europe.
On Aug 10, 2018, USFDA permitted marketing of the first mobile medical application that can be used as a method of contraception to prevent pregnancy. The app, called Natural Cycles, contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness.
How Natural Cycles works?
Natural Cycles requires women to take their temperature daily using a basal body thermometer, in the morning immediately upon waking, and to enter the reading into the app, which also tracks a user’s menstrual cycle. Basal body thermometers are more sensitive than regular thermometers and detect a minor rise in temperature, only about half of one-degree Fahrenheit, around the time of ovulation. Women using the app for contraception should abstain from sex or use protection (such as a condom) when they see “use protection” displayed on the app, which means they’re more likely to be fertile during those days.
What are clinical data?
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. The app had a “perfect 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. The app had a “typical use” failure rate of 6.5 percent, which accounted for women sometimes not using the app correctly by, for example, having unprotected intercourse on fertile days.
For more details visit
www.naturalcycles.com
www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm616511.htm
