Reproductive digital health company Natural Cycles has recently received approval from Health Canada for its app to be used as a birth control method. This milestone makes it the first app in Canada to gain a Class II Medical Device License for this purpose. The app has already received regulatory clearance in the United States, Europe, Australia, Singapore, and South Korea.
The Natural Cycles app functions as a hormone-free contraceptive, utilizing an algorithm to analyze temperature changes related to hormonal fluctuations. This method assists in determining the user’s daily fertility status. Users can input their temperature manually or sync data from compatible wearable devices, such as the Apple Watch or Oura Ring.
“Our mission has always been to reach as many women as possible and with our latest regulatory clearance from Health Canada, the Natural Cycles app is now accessible to more than 380 million women globally,” said Natural Cycles co-founder and CEO Dr. Elina Berglund Scherwitzl. “We hear from our users every day that Natural Cycles has changed their lives, and we are excited to bring another birth control option to Canada and help more Canadians prevent or plan pregnancy naturally.”
The demand for hormone-free birth control methods like Natural Cycles is rising, as evidenced by the company’s 50% growth in new user sales in 2023 according to the company.
“As the need for more contraceptive options increases worldwide, we will continue to obtain the proper regulatory approvals in new markets while also improving our product and making Natural Cycles more accessible in existing markets,” said Natural Cycles co-founder and CEO Dr. Raoul Scherwitzl. “While our team was submitting for the Health Canada license, we were simultaneously working with US and European regulators to get clearance on our Apple Watch integration and with American insurance companies to help them comply with federal mandates to cover Natural Cycles in full.”
