Natural Cycles Receives Sixth FDA Clearance for Next-Generation Fertility Algorithm

New AI-powered algorithm delivers more personalized birth control by adapting to individual cycle patterns while maintaining established effectiveness rates

NEW YORK, July 27, 2026 /PRNewswire/ -- Natural Cycles, the company behind the first and only FDA-cleared birth control app, today 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% effective when used as intended and 93% 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.

A New Phase for Digital Contraception

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."

The updated algorithm:

• Provides more Green Days while maintaining effectiveness.
• Improves performance for people with irregular cycles.
• Better handles lower-quality temperature and biomarker data.
• Personalizes more quickly as cycles naturally change over time.

Natural Cycles has also filed a patent application covering key innovations in the updated algorithm, adding to an intellectual property portfolio built over more than a decade of fertility research and technological innovation.

More Than AI Hype

While artificial intelligence has become a buzzword across healthcare, Natural Cycles has been applying machine learning to fertility prediction for more than a decade.

The company's technology analyzes millions of physiological data points each day to determine an individual's fertility status. Built on one of the world's largest real-world fertility datasets, the newly cleared algorithm represents the company's most advanced fertility modeling technology to date. It reflects years of continuous investment in data science, clinical research, and regulatory validation.

Building the Future of Digital Contraception

Each of Natural Cycles' FDA clearances has expanded either the capabilities or accessibility of regulated digital contraception:

• 2018: First-ever FDA De Novo clearance for a 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 including a Predetermined Change Control Plan (PCCP), creating a regulatory pathway for future hardware integrations.
• 2025: FDA 510(k) clearance allowing Natural Cycles to be offered both over-the-counter and by prescription.
• 2026: FDA 510(k) clearance for the next-generation NC° Fertility Algorithm.

The PCCP has since enabled the launch of the wearable designed for the NC° app, the NC° Band, as well as hardware integrations with partners such as Garmin, whose integration launched in March. Together, these innovations are expanding access to wearable-powered digital contraception while streamlining future innovation.

Natural Cycles has also received regulatory authorizations in more than eight markets worldwide, including Europe, Canada, Brazil, Australia, South Korea, and Singapore. Together, these milestones reflect Natural Cycles' continued leadership in advancing regulated digital contraception around the world.

For more information, visit www.naturalcycles.com.

About Natural Cycles:

Founded in 2013 by physicists Dr. Elina Berglund Scherwitzl and Dr. Raoul Scherwitzl, Natural Cycles is a leading women's digital health company dedicated to transforming how women understand and manage their reproductive health. The company developed the world's first FDA-cleared digital method of birth control, delivered through an app and powered by a proprietary algorithm that interprets biomarker data, including body temperature, to provide personalized cycle insights and a daily fertility status. The NC° Birth Control app is an FDA-cleared Class II medical device with six FDA clearances and has also received regulatory authorizations in Europe, Canada, Brazil, Australia, Singapore, and South Korea.

With a single subscription, the Natural Cycles app offers five dedicated modes—NC° Birth Control, NC° Plan Pregnancy, NC° Follow Pregnancy, NC° Postpartum, and NC° Perimenopause—supporting women throughout their reproductive lives. Trusted by more than six million registered users worldwide and backed by 30 peer-reviewed studies, Natural Cycles continues to pioneer science-driven, non-invasive innovations that expand access to personalized reproductive health tools and empower women to take control of their reproductive health.

Learn more at Naturalcycles.com.

SOURCE Natural Cycles