Full Breakdown
Natural Cycles Secures Sixth FDA Clearance for Next-Generation AI Fertility Algorithm
7/29/2026, 11:22:04 AM
Core Event: FDA Clears Updated NC° Fertility Algorithm
On July 27, 2026, the U.S. Food and Drug Administration granted its sixth clearance to Natural Cycles for an updated version of the NC° Fertility Algorithm. The agency concluded that the new algorithm maintains the app’s established safety and effectiveness while providing users with more “Green Days” – non-fertile days on which pregnancy protection is not required.
Background & Context
Natural Cycles, founded in 2013 by physicists Dr. Elina Berglund Scherwitzl and Dr. Raoul Scherwitzl, launched the world’s first FDA-cleared digital birth-control method in 2018. The company has since expanded the platform through hardware integrations (Oura Ring 2021, Apple Watch 2023) and a Predetermined Change Control Plan in 2024 that created a pathway for future devices. The latest clearance follows a 2025 approval that allowed the app to be offered both over-the-counter and by prescription.
Timeline of Regulatory Milestones
- 2018 – First FDA De Novo clearance for the birth-control app.
- 2021 – FDA 510(k) clearance for Oura Ring integration.
- 2023 – FDA 510(k) clearance for Apple Watch integration.
- 2024 – FDA 510(k) clearance with Predetermined Change Control Plan (PCCP).
- 2025 – FDA 510(k) clearance permitting OTC and prescription availability.
- 2026 – FDA 510(k) clearance for the next-generation NC° Fertility Algorithm (July 27).
Data & Statistics
- Effectiveness: 98 % when used as intended (perfect use) and 93 % with typical use, placing the app in the same effectiveness category as combined oral contraceptives.
- User Base: More than six million registered users worldwide.
- Algorithm Training: Tens of millions of real-world fertility data points underpin the machine-learning model.
- Performance Gains: The updated algorithm delivers additional Green Days, improves predictions for users with irregular cycles, and better handles lower-quality temperature or biomarker inputs.
Official Statements & Responses
- Regulatory Reach: Natural Cycles holds authorizations in more than eight international markets, including Europe, Canada, Brazil, Australia, South Korea and Singapore.
Verbatim Quotes
- “Years ago, the question was whether digital contraception could work. Today, Natural Cycles has demonstrated robust clinical and real-world evidence that it can,” — Dr Kerry Krauss, senior medical adviser at Natural Cycles
Why It Matters
The clearance demonstrates that AI-driven fertility prediction can meet rigorous FDA standards while offering greater flexibility than traditional fertility-awareness methods, which often label larger portions of the cycle as potentially fertile. By increasing Green Days without compromising effectiveness, the algorithm may reduce the number of days users need additional contraception, potentially improving adherence and user satisfaction.
What’s Next
Natural Cycles has filed a patent application covering key innovations in the updated algorithm and continues to expand hardware integrations, such as the NC° Band wearable and a Garmin connection launched in March 2026. The company’s regulatory pathway and growing international authorizations suggest ongoing expansion of digital contraception options worldwide.
