The Medical Device Establishment License (MDEL), issued by Health Canada’s Regulatory Operations and Enforcement Branch (ROEB), allows Femasys to directly sell its four products, FemaSeed, FemVue, FemCath and FemCerv in Canada
Femasys secures MDEL from Health Canada. (Credit: Juan Encalada on Unsplash)
Femasys, a US-based biomedical company focused on reproductive health, has obtained a Medical Device Establishment License (MDEL) from Health Canada.
Health Canada’s Regulatory Operations and Enforcement Branch (ROEB) issued the MDEL.
ROEB issues MEDL to companies allowing them to manufacture, import, distribute and commercialise the medical devices for human use in Canada.
With the license from Health Canada, Femasys can now directly sell its four products, FemaSeed, FemVue, FemCath and FemCerv, in Canada.
Femasys founder, president, and chief executive officer Kathy Lee-Sepsick said: “Obtaining an MDEL license is another milestone achieved and key step to entering the Canadian marketplace.
“We are thrilled to provide women in Canada access to Femasys’ medical products for infertility treatment and diagnosis, as well as cervical cancer diagnosis.”
FemaSeed is an infertility solution that enables directional intrauterine insemination, a process of delivering sperm into the fallopian tube where conception occurs.
It is currently in late-stage clinical development in the US and is intended to expand natural fertilisation as a first-line infertility treatment option that is less invasive and more affordable.
FemVue is the first FDA-approved product that enables real-time evaluation of the fallopian tubes with ultrasound that is safer and inexpensive than the alternative radiology exam.
FemCath is the first FDA-approved product that facilitates selective evaluation of the fallopian tubes by using it in conjunction with FemVue.
FemCerv is the first FDA-approved product that helps capture and protect a complete endocervical tissue sample in a virtually pain-free procedure, to diagnose cervical cancer.
Furthermore, Femasys is developing FemBloc, a permanent birth control product designed to be a safe, less costly option for women by eliminating surgery and implants.