Unisense FertiliTech's EmbryoScope® Receives FDA 510(k) Clearance For 5 Day Culture Of Human Embryos In IVF

Main Category: Fertility
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 14 Oct 2011 - 2:00 PDT


The Food and Drug Administration has cleared Unisense FertiliTech's EmbryoScope® for clinical use in the United States. The EmbryoScope® is a tri-gas IVF incubator with a built-in camera for automated time-lapse imaging of fertilized oocytes in a safe incubation environment from conception until the time of transfer. Embryo development may be continuously observed on the instrument interface without disturbances to embryo culture for up to 5 days.

Separate processing units control the incubation environment and the data acquisition to ensure safe and reliable operation. The EmbryoScope® allows incubation of up to 72 individual embryos in six sterile disposable EmbryoSlides® each with a capacity for 12 embryos.

CEO Jens Gundersen states "the clearance will allow the newly established USA office, FertiliTech Inc. to commence commercial activities in the US".

Unisense FertiliTech A/S was founded in 2003 as a subsidiary of Unisense A/S. The company develops and sells technology and software for improvement of assisted reproduction. The company has 34 employees and a domicile in Aarhus Denmark.

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