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Unisense FertiliTech obtains FDA 510(k) approval for EmbryoViewer software

Unisense FertiliTech has received 510(k) approval from the US Food and Drug Administration for its Compare & Select feature in the EmbryoViewer software, an accessory in the EmbryoScope time-lapse incubator.

Unisense

EmbryoScope time-lapse system will help IVF professionals to select embryos for transfer when treating infertile couples or individuals intend to become a parent.

Unisense said that 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.

Unisense FertiliTech chief commercial officer Vagn Rasmussen said the FDA 510(k) clearance for the EmbryoViewer software will aid IVF professionals in the selection of embryos that are likely to produce a live birth.

"We have developed a software that allows IVF professionals to observe embryo development events which they may have previously missed," Rasmussen added.

According to Rasmussen, the new software provides embryologists a new tool to develop a set of models, which can be used for scoring embryos, and it also helps in offering more informed basis for a better decision.

Unisense 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.


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