The FDA Approves a Contraceptive App for the First Time

August 21, 2018 - 3 minutes read

MedTech app developerMany women around the world lack access to affordable, accurate contraception. To address this, Elina and Raoul Berglund created an app called “Natural Cycles.” The app augments our perspective of fertility by tracking cycles and body temperature in women. When a woman is fertile, the couple can avoid having sex, and when a woman is out of fertility range, it’s safe enough to prevent pregnancy.

Recently, the app was approved by the U.S. Food and Drug Administration (FDA). This unprecedented move could help usher in more innovative healthcare applications from MedTech app developers.

Fertile Potential

Natural Cycles wasn’t developed in San Francisco, New York, or any of the usual tech hubs. Its founders created the app in Switzerland, and they recently moved company headquarters to Sweden. To develop a highly accurate fertility tracker, they used the tracker on themselves when preventing pregnancy and, later, to get pregnant on the first try.

Pills, intra-uterine devices, and condoms can cost thousands of dollars, but this app tracks fertility using the traditional “rhythm method” that was previously thought to be largely ineffective, with a 24% failure rate. However, during clinical trials, when the app was used properly, the failure rate decreased to 6.5%, which is better than the pill (9%) and condoms (18%).

Further, when women used the app perfectly, the failure rate was a measly 1.8%. To use the app perfectly, the user is required to take their basal body temperature every morning at the same time. After putting body temperature data into the app, the next step is to indicate whether the user is actively menstruating. Using this information, the app can deduce when the user is most likely to be fertile.

Still Some Issues to Address

But while the app promises low failure rates, Swedish law enforcement is investigating 37 women who became pregnant after using the Natural Cycles app. Because the app’s effectiveness depends on the user’s ability to use the app every day, it may not be the best contraceptive method for most women.

Lauren Streicher agrees. Streicher, a professor at Northwestern who teaches on clinical obstetrics and gynecology, says, “What is this, the 1950s? Instead of using real contraception for women that is proven to be safe and effective, this is essentially advocating an anti-contraception approach. To have the FDA endorse an app as being safe is just kind of mind-boggling.”

Since other MedTech apps will face similar, even easier, approval processes, we must ask ourselves where we should draw the line on complex health issues becoming falsely simplified by technology.

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