Daysy Clinical Study Results and Medical Device Certifications

With over 40 years of research and innovation, Valley Electronics has become a pioneer in fertility tracking technology. The proprietary, clinically validated algorithms behind Lady-Comp and Daysy are built on the analysis of more than 10 million menstrual cycles and confirmed through independent, peer-reviewed studies. These studies highlight the exceptional accuracy, reliability, and medical-grade performance of our fertility trackers in identifying fertile and non-fertile phases with high precision.

Study on the performance of fertility trackers

How accurately do the fertility trackers Daysy and Lady-Comp identify your fertile days?

To give women a transparent basis for decision-making, it’s important to examine how accurately fertility trackers calculate fertile and non-fertile days, and what factors might influence the results. Equally important is ensuring these evaluations are carried out under strict scientific standards. That’s why we conducted a scientific study in collaboration with experts at Georgetown University.

Data from more than 5,300 women and over 107,000 cycles reveal exciting insights

Key findings of the study

The Daysy fertility tracker correctly calculated 99.4% of infertile days, a result that demonstrates exceptional fertility tracker accuracy.

Only 0.6% of all infertile days displayed by the device were calculated incorrectly - one of the strongest documented performances among natural family planning (NFP) methods and digital ovulation tracking devices.

These results show that Daysy’s algorithm can distinguish fertile from infertile phases with very high precision, offering one of the most accurate, hormone-free fertility tracking solutions available.

Conclusion

The results of the study show that our fertility tracker algorithm can determine fertile and non-fertile days with the highest precision.

For women, this means reliable support for cycle tracking - hormone-free and evidence-based. Those who wish to review the full study in detail can find it here:

Discover all the details of the study

Key study details:

Average age: 30 years, with a Body Mass Index (BMI) of 22.07 (normal weight range: 18.5–25)
On average, women used the fertility tracker for 22 complete cycles
Average cycle length: 29.5 days
Average follicular phase (before ovulation): 16.8 days
Average luteal phase: 12.8 days

Regulations, Certificates, Standards

We design, develop, manufacture, and control all our medical-grade fertility trackers in full compliance with current international regulations and standards. Our products undergo regular audits and inspections by competent authorities in the EU, USA, Canada, and many other countries. This extensive regulatory and quality-control process ensures that your device remains safe, accurate, and reliable throughout its entire lifecycle.

Regulation • EU 2017/745

Medical devices placed on the EU market must comply to this very strict legislation to ensure their safety and performance. Furthermore, this regulation outlines the responsibilities of manufacturers and transparency through the database EUDAMED.

Certification • ISO 13485

Our products are developed under our certified quality management system. To meet customer and regulatory requirements for safety and efficacy ISO 13485 is the internationally recognized standard for quality management systems in the design and manufacture of medical devices.

Standard • ISO 14971

This international standard provides a process for manufacturers to identify risks, mitigate them and control their effectiveness throughout the product lifecycle of a medical device.

Standard • ISO 10993

This is a family of standards to ensure that materials and medical devices are safe for contact with the human body. This framework assesses potential biological risks, such as allergic reactions, irritation, or toxic effects.

Standard • ISO 60601-1

Basic safety and essential performance of medical devices that incorporate electronics are guided by the ISO 60601-1 standard family. Key requirements mitigate risks from electrical, mechanical, thermal, and many more hazards. This includes electromagnetic compatibility and special requirements for medical devices used at home.