Unisense FertiliTech’s EmbryoScope Receives FDA 510(k) Clearance for 5 Day Culture of Human Embryos in IVF

Unisense FertiliTech’s EmbryoScope Receives FDA 510(k) Clearance for 5 Day Culture of Human Embryos in IVF

PR Newswire

AARHUS, Denmark, October 13, 2011 /PRNewswire/ —

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.

http://www.fertilitech.com

SOURCE Unisense FertiliTech A/S

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