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OvuSense Approvals

How do I know OvuSense is safe?

OvuSense is a fully regulated class II medical device.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.

What's the Sensor made of?

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 medical grade silicone. There are no joins or crevices to trap contaminants. The OvuSense Sensor has so far been used in over 30,000 cycles.

How was the Sensor tested?

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. OvuSense 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 sensor for measuring vaginal temperature.

How was OvuSense proved?

A further clinical trial in 2012 resulted in a number of publications by Papaioannou et al.. This trial set out to test OvuSense in the most rigorous 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.

Clinically Proven

The only Class II medical device fertility monitor. Proven in clinical trials and in 30,000 cycles with women just like you.

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