Unisense FertiliTech’s EmbryoScope® Receives FDA 510(k) Clearance for day 5 culture of human embryos in IVF

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.
Source: Unisense Fertilitech