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OvuSense Approvals

How do I know OvuSense is safe?

The OvuSense family of products are fully regulated as class II medical devices. In Europe, OvuSense is CE marked in accordance with the European Medical Devices Directive 93/42/EEC. In the USA, OvuSense is cleared by the FDA for sale under 510(k) number K122337. OvuSense is also approved for sale in Canada under the CMDCAS regulations, in Australia under TGA and Singapore under HSA.

What's are the OvuSense sensors made of?

The OvuFirst Sensor is designed for applying to the skin by means of an arm or wristband, and made of a hard plastic outer shell with materials approved for skin contact, and contains no natural rubber latex or phthalates. The OvuCore Sensor is designed for placing in the vagina overnight and is hygienic, biocompatible, and contains no natural rubber latex or phthalates. The contact surfaces of the OvuCore Sensor are made from medical grade silicone. There are no joins or crevices to trap contaminants. The OvuCore Sensor has so far been proven in over cycles of use.

How do I know OvuSense is safe?

The OvuFirst Sensor has undergone full electrical and safety testing. Full biological safety evaluation testing has been carried out for the OvuCore sensor under ISO 10993 regulations (International Standards Organization) with all tests showing that the use of the OvuCore sensor presents no biological or toxicity risk. Further bio-compatibility testing has confirmed the effectiveness of daily cleaning of the OvuCore sensor with soap and water. It also complies with part 15 of the Federal Communications Commission (FCC) Rules for electronic products, FCCID: Z8YM009-V1.

How was OvuSense developed?

Back in the early 2000s, two veterinary scientists from the University of Bristol in the UK came up with the idea of measuring temperature more accurately to improve animal and human health. Fertility Focus was formed in 2005 to develop their idea and, after testing several concepts, produced a prototype OvuCore sensor for measuring vaginal temperature. The OvuSense Pro clinician portal was developed in 2019 and launched in 2020. The OvuFirst Sensor went through two years of development before launching in 2021.

How was OvuSense proved clinically?

A clinical trial in 2012 resulted in a number of publications by Papaioannou et al.. This trial set out to test the OvuCore technology in the most rigorous way possible: by comparing it with gold-standard ultrasound measurements and other commonly available testing methods. The OvuSense Pro clinician portal was proved through three clinical publications: publications by Hurst and Karoshi et al... The OvuFirst Sensor was proven in side by side trials using OvuCore readings as a 'gold standard', enabling proof of concept, a dedicated algorithm and clinical data to be recorded for publication.

What did the original OvuCore trials show?

The 2012 trial showed that OvuCore is 99% accurate at detecting the date of ovulation, as well as showing that OvuCore also detects when ovulation does not occur. A further publication reported that users found OvuSense comfortable and easy to use. A complete list of publications and trial details are available here.

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