The Food and Drug Administration (FDA) has approved the first app billing itself as "digital contraception" to market in the U.S. despite concerns from officials in two countries about unwanted pregnancies as a result of the app's use.
The FDA confirmed the approval of the "contraception" designation for the mobile app "Natural Cycles" last week, which bills itself as providing an "algorithm that accurately detects and predicts ovulation and fertility."
Natural Cycles, a Swedish company, is the first app in the U.S. to be approved for this designation. A spokeswoman for the FDA said in a statement that the app could be "effective" as contraception, but warned of the innate risks of contraceptive use.
"Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly," said Terri Cornelison, an assistant director at the agency's Center for Devices and Radiological Health.
"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 designation comes despite the company facing investigation from the U.K.'s Advertising Standards Authority, according to The Guardian, over the app's advertisements billing the software as "highly accurate" and as a "contraceptive.
A second investigation in Sweden, reported by Vice News, was the result of a hospital reporting 37 unwanted pregnancies from users of the app. Swedish authorities expect the investigation to conclude in September.
Deborah Kotz, an FDA spokeswoman, told Vice News that concerns from Swedish authorities fell in line with typical concerns about the risks of contraceptive use of the app.
“An increase in the absolute numbers of unintended pregnancies is expected with a growing number of users,” Kotz said. “We reached out to the Swedish authorities and feel that the information regarding the pregnancies in Sweden is consistent with our knowledge concerning the pregnancy risks associated with use of this device.”
Natural Cycles commended the FDA's decision on Twitter on Friday, saying the company was "delighted" to win FDA approval.
"We are delighted that the US Food and Drug Administration (FDA) has cleared Natural Cycles as the first digital method of birth control in the US #contraception #FDA," the company tweeted.