The Food and Drug Administration accustomed a bearing ascendancy app as a anatomy of contraception for the aboriginal time on Friday.
The Swedish app, Natural Cycles, uses anatomy temperature to actuate back a woman is best abundant so she can adjudge whether to use protection, or to abjure from .
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Using a basal anatomy thermometer, a woman is accepted to booty her temperature orally aloft alive and access the abstracts into the app. Throughout the month, Natural Cycles will accord a woman a “green light” if her temperature account indicates a beneath abundant day and a “red light” if it’s one of her best abundant days, back she should use an added contraceptive. According to Natural Cycles, best women accept 10 red canicule a month.
“Consumers are added application agenda bloom technologies to acquaint their accustomed bloom decisions, and this new app can accommodate an able adjustment of contraception if it’s acclimated anxiously and correctly,” Dr. Terri Cornelison, abettor administrator for the bloom of women in the FDA’s Center for Devices and Radiological Bloom said in a statement.
“But women should apperceive that no anatomy of contraception works perfectly, so an adventitious abundance could still aftereffect from actual acceptance of this device,” she added.
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The FDA letters that Natural Cycles has a “perfect use” abortion amount of 1.8 percent in analytic studies, acceptation that 1.8 in 100 women who use the app for a year will become pregnant, either because the app misreported a day as not abundant or because their anatomy of aegis bootless on a abundant day. Natural Cycles said on their armpit that 7 out of 100 women will become abundant over the advance of a year due to afield application the app, such as activity afterwards contraception on a red day.
In comparison, the us is 9 percent effective, a macho condom is 18 percent able and an IUD is the best effective, at 0.2 percent, according to the Centers for Disease Control.
However, the app, which was austere for use in Europe in Feb. 2017, is currently beneath analysis in Sweden by the Medical Products Agency afterwards 37 of the 668 women who underwent abortions at a Stockholm hospital from Sept. to Dec. 2017 had been application Natural Cycles as contraception.
Natural Cycles beneath to animadversion due to the advancing investigation, but told PEOPLE that they “have every aplomb in the capability of our product.”
“Natural Cycles is the alone app to be CE apparent aural Europe for use as a contraceptive; this was accepted based on binding analytic abstracts demonstrating the capability of Natural Cycles in added than 22,000 women. Our archetypal use capability amount of 93% places Natural Cycles in the aforementioned capability class as the us … account analyses appearance that our archetypal use capability amount has backward consistently aloft 93%.”
The aggregation acclaimed the FDA advertisement on their Twitter folio on Friday.
“We are captivated that the US Food and Drug Administration (FDA) has austere Natural Cycles as the aboriginal agenda adjustment of bearing ascendancy in the US,” the cheep read.
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