FDAnews
www.fdanews.com/articles/173899-fda-grants-de-novo-clearance-for-invocell

FDA Grants De Novo Clearance for INVOcell

November 4, 2015

The FDA has granted Medford, Mass.-based INVO Bioscience’s de novo request for its INVOcell system for the incubation of eggs and sperm during fertilization and early embryonic development.

The device produced pregnancy rates equivalent to traditional in vitro fertilization treatments in clinical studies, the company says.

Benefits include a more natural and stable vaginal incubation than in a conventional IVF incubator, a reduced risk of incorrect embryo transfers, a lower cost of infertility treatments and increasing geographic accessibility. — Michael Cipriano