Medical device firm Invo Bioscience has received de novo approval from the US Food and Drug Administration (FDA) for its intravaginal culture system, INVOcell.
The INVOcell has been developed to be used for the incubation of eggs and sperm during fertilization of early embryo development.
The system uses women’s vagina as a natural incubator to support embryo development, while in conventional infertility treatments such as in vitro fertilization (IVF), the eggs and sperm develop into embryos in a laboratory.
According to the firm, INVOcell device reduces the risk of incorrect embryo transfers and provides a natural and stable vaginal incubation than in a conventional IVF incubator.
Invo Biosci CEO Katie Karloff said: "INVOcell has the ability to significantly transform the way in which fertility clinics across the US assist infertile patients to achieve their desired outcomes in a simpler, more natural and cost effective manner.
"It has been a long process to de novo clearance and we are so pleased to have this approval from the FDA to begin marketing and selling in the US."
In 2012, World Health Organization (WHO) announced that there are around 48.5 million couples across the globe that have fertility issues, of which 6.7 million of the couples are in the US.