FDA approves Unisense FertiliTech EmbryoScope
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.
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.