Unisense FertiliTech A/S Receives FDA Clearance for Tool to Aid in Embryo Selection to Improve IVF Treatment

AARHUS, Denmark, Sept. 24, 2014 /PRNewswire/ —

Customized embryo evaluation tools for IVF practices now available for clinical use in the USA

World leading  time-lapse technology provider within the field of IVF, Unisense FertiliTech A/S, has  received FDA 510(k) clearance for its "Compare & Select" feature in the EmbryoViewer™ software – an accessory to the EmbryoScope® time-lapse incubator – which assists IVF professionals in selecting embryos for transfer when treating infertile couples or individuals wishing to become a parent.  

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(Photo: http://photos.prnewswire.com/prnh/20140924/708403 )

"We’re excited to receive the FDA 510(k) clearance for the EmbryoViewer™ software, and believe this will aid IVF professionals in the selection of embryos that are likely to produce a live birth," says Vagn Rasmussen, Chief Commercial Officer of Unisense FertiliTech. "We have developed a software that allows IVF professionals to observe embryo development events which they may have previously missed. The newly released software provides embryologists a new tool to design a set of models that can be used for scoring embryos and provide a stronger and more informed basis to make a better decision." The EmbryoViewer™ software with the Compare & Select feature will be shown at the upcoming American Society for Reproductive Medicine in Honolulu October 18-22 2014.

A major challenge in the field of IVF is selection of the best embryo to transfer back to the patient.  Traditionally, IVF professionals have been limited in their ability to evaluate embryos due to the stringent culture conditions, which require embryos to remain in a stable environment.  For this reason, embryos could only be removed for very short observation periods daily.  Since the introduction of time-lapse technology in the IVF lab, a wealth of knowledge has been gained about embryo development.  

Unisense FertiliTech A/S was the first company who developed a time-lapse system that received FDA 510(k) clearance for clinical use in ART procedures and has a knowledge base of more than 200,000 treatments worldwide, which it is using to develop tools to improve embryo evaluation.

Although a large body of scientific evidence indicates that measuring the development rate of embryos can be used to predict implantation potential, the optimum intervals and timings, as well as the key variables, appear to vary between clinics. This means that development of a universal model to select the highest potential embryos has been a big challenge even with access to large amounts of outcome data. This new software presents the IVF professional with the possibility to create clinic-specific models tailored to their own IVF practice. The evaluation criteria already implemented for embryo selection in a specific clinic can be converted into a model in the Compare & Select feature of the EmbryoViewer™ software.

A recent study performed at IVI in Spain, and published in the September issue of Fertility & Sterility, has reported improvement in clinical outcomes when using a customized embryo evaluation model. The model used in the study was developed and implemented using the Compare & Select feature of the EmbryoViewer™ software. IVI routinely uses this software feature in daily clinical practice.

About Unisense FertiliTech A/S: 

Unisense FertiliTech A/S was founded in 2003 to develop technology to improve human embryo assessment in assisted reproduction. Unisense FertiliTech has developed and manufactures the EmbryoScope™ time- lapse system, facilitating improved IVF treatment, flexible work routines and effective communication through comprehensive documentation of embryo development and evolving improvements in selection. The system is FDA 510(k) cleared and CE marked as a Class II medical device. 

Our mission is to help infertile couples achieve their dream of parenthood through extensive research and clinical documentation.  We provide fertility clinics with innovative technologies that increase the chances of positive pregnancy outcomes  

"Your success starts here" 

Unisense FertiliTech A/S


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