Digital reproductive health company Natural Cycles has received regulatory clearance from Brazil’s health regulatory agency ANVISA, allowing the company to market its birth control app to Brazil’s population of 220 million people. This latest approval significantly expands the app’s global reach, adding to existing clearances in the United States, European Union, Canada, Australia, South Korea, and the United Kingdom.
With this new regulatory milestone, Natural Cycles has now secured access to more than 1 billion people worldwide who can potentially use its hormone-free contraceptive solution.
“Natural Cycles remains committed to providing as many women as possible access to a reliable and science-backed hormone-free birth control method, which is why we are excited to receive approval as a medical device by Brazil’s ANVISA,” says Dr. Raoul Scherwitzl, co-CEO and co-founder at Natural Cycles. “With our latest clearance, we will start developing a comprehensive market strategy to ensure that both healthcare professionals and women in Brazil are well informed on the NC° Birth Control product, its benefits, and its effectiveness.”
The Natural Cycles app functions as a non-hormonal contraceptive method by using an algorithm to analyze body temperature changes related to hormonal fluctuations throughout the menstrual cycle. This analysis helps determine a user’s daily fertility status. Users can input their temperature data manually or sync information from compatible wearable devices such as the Apple Watch or Oura Ring.
The expansion into Brazil represents a significant opportunity for Natural Cycles in Latin America’s largest country. Brazil has a substantial population of reproductive-age women who may benefit from additional contraceptive options.
This clearance follows other recent regulatory successes for the company, including approval from Health Canada in January 2024, which made Natural Cycles the first app in Canada to receive a Class II Medical Device License for contraceptive use.
