Natural Cycles becomes first digital contraceptive app approved by the FDA

Andy Boxall | August 15, 2018

App Business

Natural Cycles has become the first mobile medical app for contraception to be approved by the U.S. Food and Drug Administration. This will allow the app to market itself as a contraceptive, and follows the app’s classification as a medical device in Europe last year.

In a press release, the FDA’s Terri Cornelison, M.D., Ph.D., assistant director for the health of women in the FDA’s Center for Devices and Radiological Health, writes:

“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. But women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”

The FDA notes studies into the apps effectiveness, which state a failure rate of 1.8 percent when the app is used correctly, raising to 6.5% when the app is not always used correctly. However, Natural Cycles approval by the FDA has caused controversy, and not all groups support the decision.

Speaking to Vox, Lauren Streicher, a professor and Northwestern university called the app “problematic,” and said:

“This isn’t science; this is craziness. We’ve already developed good, safe, reliable methods of contraception that are available to us. This app is completely taking women back in time.”

Natural Cycles costs $80 per year, which includes delivery of a basal thermometer essential to the app’s use, or $10 per month if the thermometer is not required. It currently has 900,000 users.

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