March 8, 2021

Clue gets FDA approval for digital contraceptive

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Clue Birth Control is 92% effective with typical use and 97% effective with perfect use. Clue Birth Control algorithmically combines menstrual cycle data with a mathematical model to predict which days are high or low risk for pregnancy. After consulting Clue Birth Control, users can adapt their behaviors as necessary, for example by using condoms or avoiding sex that may result in pregnancy when the app indicates high risk.

Clue Birth Control will be available as a feature within the Clue app for eligible US-based users in 2021. Further countries will follow subject to the relevant regulatory approvals, as the contraceptive feature is a regulated medical device. Clue Birth Control doesn’t require users to track anything other than their period start dates, and its smart technology estimates a more accurate high risk window than traditional methods based only on period data. As the algorithm learns about a woman’s cycle over time, the predictions become more personalized, and the high risk window estimated to contain ovulation can become shorter. The fact that no daily temperature measurements, other clinical observations or hardware are required is a major innovation in user-friendliness as compared to other fertility awareness-based methods of contraception.

To coincide with Clue’s new reality as a regulated medical device company, there is a strengthening of the company’s senior team, with founder Ida Tin moving to the role of Chairwoman of the Board, and the appointment of Audrey Tsang (formerly Clue’s Chief Product Officer) and Carrie Walter (formerly Clue’s General Counsel) as co-CEOs. In her prior role as General Counsel, Carrie Walter, who joined Clue from Freshfields' international regulatory practice, was responsible for Clue's FDA application and has overseen the company's transition to a regulated company. Meanwhile, Audrey Tsang, who has led product strategy for global brands at scale, including at Pinterest and Yelp, led the development of the Clue Birth Control feature as part of her responsibility for Clue's overall product portfolio as Clue’s Chief Product Officer. Now that Clue is evolving from a health and lifestyle mobile app into a regulated, medical device-grade mobile app, together as Clue’s new Co-CEOs, Carrie and Audrey will focus on bringing accessible birth control to many more people around the world. At the same time, Clue will continue to evolve as the trusted female health companion that already brings data-driven insights and science-backed information to millions at every stage of their reproductive lives.