Merck KGaA has secured FDA approval to sell a benchtop embryo incubator in the U.S. The 510(k) clearance sets Merck up to make the device available to IVF clinics in the first half of next year.
Geri, the device, is made up of six independently controlled chambers that each house an embryo. Each chamber has multiple heating elements and individual carbon dioxide monitors. A camera captures pictures of the embryos every five minutes.
The purpose of these technologies is to enable fertility clinics to monitor the embryos and adjust the conditions inside each chamber without having to frequently lift the device’s lid or otherwise disrupt the cells.
Merck landed global marketing and commercialization rights covering Geri and three other fertility technologies from Genea Biomedx in 2015. European CE marks for Gavi, an automated vitrification instrument, and Geri followed later that year. But getting clearance to sell the devices in the U.S. has taken longer.
Genea and Merck made the first regulatory breakthrough in the U.S. earlier this year when they got the green light to sell culture media for use in the fertilization of eggs and other processes. Clearances for a buffer for removing oocytes from ovarian follicles and a device for warming blastocyst-stage embryos followed.
The subsequent nod for Geri means Merck is now starting to establish the fertility portfolio it foresaw when it struck the deal with Genea.
“Offering Geri in the U.S. will allow us to further our aspiration of becoming an integrated fertility treatment partner,” Rehan Verjee, chief marketing and strategy officer at Merck’s biopharma business, said in a statement.