FDA approves INVOcell system for patients diagnosed with infertility- INVO Bioscience

The FDA has granted INVO Bioscience's de novo request for the INVOcell system for treating infertility, the first intravaginal culture system granted marketing clearance in the United States. Results of a randomised 40 patient comparative study demonstrated the INVOcell procedure performed equivalent to that of IVF, with INVOcell producing a 65% pregnancy rate, as well as offering cost reductions compared to traditional IVF treatment.

Comment: INVOcell is an innovative medical device used in infertility treatment which enables conception and early embryo development to occur within a woman's own body rather than in a laboratory. The INVOcell is a small capsule for the incubation of eggs and sperm for embryo development. Unlike conventional infertility treatments such as in vitro fertilization (IVF), where the eggs and sperm develop into embryos in a laboratory, INVOcell utilizes the women’s vagina as a natural incubator to support embryo development. This novel INVOcell technology offers patients a more personal approach to achieving pregnancy, decreases the risk of multiple births and reduces the chance for creating unused embryos. It is also claimed to reduce costs.