Natural Cycles, the company behind the first and only FDA-cleared birth control app, announced its sixth FDA clearance, marking another milestone in the advancement of regulated digital contraception. The clearance covers the company's next-generation AI-powered NC° Fertility Algorithm, which combines advanced statistical modeling with machine learning trained on tens of millions of real-world fertility data points to deliver more individualized fertility predictions.
The FDA clearance was supported by evidence demonstrating that the updated algorithm maintains Natural Cycles' established safety and effectiveness while giving many users more Green Days—days when the app confirms pregnancy protection is not needed.
"People don't just want effective birth control; they want a method that fits naturally into their lives," said Dr. Elina Berglund Scherwitzl, CEO and co-founder of Natural Cycles. "One of the unique advantages of a software-based contraceptive is that it can continue to evolve. As our scientific understanding of fertility grows and we continue to learn from more than a decade of real-world data, we can responsibly refine the technology through rigorous research, clinical validation, and FDA review. This latest clearance is the result of that work, helping us give many users more flexibility while maintaining the effectiveness they rely on."
Natural Cycles remains 98 per cent effective when used as intended and 93 per cent effective with typical use. These rates, supported by extensive peer-reviewed clinical research and real-world evidence, put it in the same effectiveness category as the combined oral contraceptive pill.
As digital contraception has matured into an established category, innovation is shifting from proving it works to continually improving performance.
While Natural Cycles is rooted in fertility awareness principles, digital contraception represents a distinct category that uses technology to personalize fertility predictions. Traditional fertility awareness methods often define larger portions of the menstrual cycle as potentially fertile to account for uncertainty, which can reduce flexibility for users. Natural Cycles' next-generation algorithm takes a different approach, combining advanced physiological modeling and machine learning to more precisely identify fertile and non-fertile days, increasing the number of Green Days while maintaining the app's established effectiveness.
"Years ago, the question was whether digital contraception could work. Today, Natural Cycles has demonstrated robust clinical and real-world evidence that it can," said Dr. Kerry Krauss, MD, MPH, FACOG, Senior Medical Advisor at Natural Cycles. "The next chapter for digital contraception is making it more personalized and easier to use while maintaining the same high standard of safety. This FDA clearance demonstrates how advances in AI and machine learning can improve the user experience while preserving the scientific rigor expected of a regulated medical device."
