CrossBay Medical Announces FDA and CE Mark Marketing Authorizations for its IVF Embryo Transfer Catheter Set

SAN FRANCISCO, May 17, 2017 /PRNewswire/ -- CrossBay Medical, Inc., today announced receipt of United States Food and Drug Administration (FDA) clearance of its product, the CrossBay IVF Embryo Transfer Catheter Set. The device has also received clearance to commercialize the product in Europe by obtaining its CE mark. The product is intended for ultrasound-guided transfer of embryos into the uterine cavity following in vitro fertilization. The embryo transfer procedure is the last step in the IVF process and critically important to the success of the procedure.

In 2012, there were approximately 1.76 million IVF cycles performed globally. While IVF has become the method of choice for infertile couples and infertility specialists, the average failure rate has remained unchanged over the past decade at approximately 70%. Insertion and delivery problems associated with embryo transfer catheter techniques contribute significantly to this failure rate.