Unisense FertiliTech’s EmbryoScope has received Food and Drug Administration (FDA) clearance for clinical use in US.
The EmbryoScope is a tri-gas IVF incubator with a built-in camera for automated time-lapse imaging of fertilised oocytes in a safe incubation environment from conception until the time of transfer.
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Utilising EmbryoScope, embryo development can be continuously monitored on the instrument interface without disturbances to the embryo culture for up to 5 days.
The EmbryoScope allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides, each with a capacity for 12 embryos.
Unisense FertiliTech CEO Jens Gundersen said the clearance will allow the newly established USA office, FertiliTech, to commence commercial activities in the US.
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