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Natural Cycles Secures FDA Clearance for AI-Driven Fertility Algorithm

Regulators have granted Natural Cycles its sixth FDA clearance, greenlighting a next-generation algorithm designed to sharpen the precision of its digital contraceptive app. By leveraging machine learning on a decade of physiological data, the update promises to expand "Green Days" for users while maintaining established effectiveness rates.

Natural Cycles Secures FDA Clearance for AI-Driven Fertility Algorithm

The updated NC° Fertility Algorithm moves beyond traditional fertility awareness models, which often categorize large windows of a menstrual cycle as fertile to err on the side of caution. Instead, the new software uses advanced statistical modeling to interpret user data, allowing for more granular, individualized predictions. According to the company, this refinement benefits users with irregular cycles and improves accuracy even when temperature or biomarker data quality varies.

Dr. Elina Berglund Scherwitzl, CEO and co-founder, noted that the software-based nature of the contraceptive allows it to evolve alongside growing scientific understanding. While the medical community once questioned the viability of digital contraception, the platform maintains a 98% effectiveness rate with perfect use, putting it on par with the combined oral contraceptive pill. This latest regulatory approval follows a series of milestones for the company, including integrations with the Oura Ring, Apple Watch, and Garmin, as well as authorization for both prescription and over-the-counter access.

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