FDA grants 510(k) clearance for Unisense FertiliTech’s EmbryoViewer software

25 September 2014 (Last Updated September 25th, 2014 18:30)

The US Food and Drug Administration has granted 510(k) clearance for Unisense FertiliTech's Compare & Select feature in the EmbryoViewer software, an accessory in the EmbryoScope time-lapse incubator.

Unisense

The US Food and Drug Administration has granted 510(k) clearance for Unisense FertiliTech's Compare & Select feature in the EmbryoViewer software, an accessory in the EmbryoScope time-lapse incubator.

The company said that 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.

The EmbryoScope time-lapse incubator assists IVF professionals in selecting embryos for transfer when treating infertile couples or individuals who want to be a parent.

Unisense FertiliTech chief commercial officer Vagn Rasmussen said: "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.

"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."

"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 company has obtained FDA 510(k) and CE Mark approvals for the time-lapse system as a Class II medical device. It can be employed for clinical use in ART procedures.

A recent study has showed improvement in clinical outcomes when using a customised embryo evaluation model, which was developed and implemented using the Compare & Select feature of the EmbryoViewer software.


Image: EmbryoScope time-lapse system. Photo: courtesy of PR Newswire/ Unisense FertiliTech A/S.