OvuSense is a fully regulated medical device and complies with all the necessary regulatory certifications for the countries in which it is available.
In Europe, OvuSense is CE marked in accordance with the European Medical Devices Directive 93/42/EEC.
In the USA, OvuSense is approved 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.
OvuSense complies with part 15 of the Federal Communications Commission (FCC) Rules for electronic products, FCCID: Z8YM009-V1.
The OvuSense Sensor is hygienic, biocompatible, and is not made with natural rubber latex or phthalates. The contact surfaces of OvuSense Sensors are made from seamless medical grade silicone. There are no joins or crevices to trap contaminants. Full biological safety evaluation testing has been carried out under ISO 10993 regulations (International Standards Organization) with all tests showing that the use of the OvuSense Sensor presents no biological or toxicity risk. Further bio-compatibility testing has confirmed the effectiveness of daily cleaning of the OvuSense Sensor with soap and water. The OvuSense Sensor has so far been used in over 6,500 cycles.
How was OvuSense developed?
Back in the early 2000s, two vets 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 sensor for measuring vaginal temperature.
Our team of women's health and medical device experts took the prototype through clinical trials in the UK and China. These trials showed us something completely new about how temperature behaves during the reproductive cycle and led to the development of OvuSense, with it's unique ability to predict the onset - and detect the date - of ovulation.
How was OvuSense proved?
A further clinical trial in 2012 resulted in a number of publications [1-5]. This trial set out to test OvuSense in the most rigourous way possible: by comparing it with gold-standard ultrasound measurements and other commonly available testing methods.
What did the trials show?
The 2012 trial showed that OvuSense is 99% accurate at detecting the date of ovulation, as well as showing that OvuSense also detects when ovulation does not occur. A further publication reported that users found OvuSense comfortable and easy to use.