Hamilton Thorne Ltd.'s medium for washing human oocytes and embryos in the process of Assisted Reproductive Technologies, or ART, has been approved in the U.S.
The solution was granted 510(k) clearance, which will allow Beverly, Mass.-based Hamilton Thorne to market its first product in the Gynemed branded media line in the U.S., according to the company's Sept. 10 press release.
Gynemed GM501 Wash media is used to wash and handle human oocytes and embryos as they are prepared for certain procedures in the process of in vitro fertilization, an ART more commonly known as IVF, such as before and after cryopreservation or before the embryo transfer process.
Hamilton Thorne expects the product to initially hit U.S. shelves in the fourth quarter, with a full roll-out in the first half of 2020. The full line of Gynemed products is already available in Europe.
The healthcare equipment company manufactures precision laser devices and advanced image analysis systems for the fertility, stem cell and developmental biology research markets.
