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Unisense Fertilitech receives FDA clearance

Unisense Fertilitech A/S has received FDA clearance for its “Compare & Select” feature in the EmbryoViewer software.

The software is an accessory to the company’s EmbryoScope time-lapse incubator which assists IVF professionals in selecting embryos for transfer.

“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. 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,” says Vagn Rasmussen, Chief Commercial Officer of Unisense Fertilitech.