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Femasys Inc. Obtains Medical Device Establishment License from Health Canada
ATLANTA, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide
About this update from Femasys Inc.
[{"type":"text","content":"ATLANTA, Aug. 31, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting significant unmet needs for women worldwide with two lead revolutionary product candidates in late-stage clinical development for reproductive health in addition to innovative diagnostic products constituting a broad portfolio of in-office accessible solutions, today announced that it has obtained a Medical Device Establishment License (“MDEL”) from Health Canada (License Number 24825). The MDEL license is issued by Health Canada’s Regulatory Operations and Enforcement Branch (ROEB) to companies for the activities of manufacturing, importing and distributing and selling of medical devices for human use in Canada. This license allows Femasys to directly sell its four products, FemaSeed®, FemVue®, FemCath® and FemCerv®, approved in Canada. “Obtaining an MDEL license is another milestone achieved and key step to entering the Canadian marketplace,” said Kathy Lee-Sepsick, founder, president and chief executive officer of Femasys. “We are thrilled to provide women in Canada access to Femasys’ medical products for infertility treatment and diagnosis, as well as cervical cancer diagnosis.” More information on Femasys’ approved products in Canada (FemaSeed, FemVue, FemCath and FemCerv) is below: About FemaSeed® FemaSeed is a first-of-its-kind infertility solution in late-stage clinical development in the U.S. for directional intrauterine insemination that delivers sperm to the fallopian tube where conception occurs. It is intended to augment natural fertilization as a first-line infertility treatment option that is less invasive and more affordable than in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). About FemVue® FemVue is the first FDA-cleared product that creates natural contrast to allow for real time evaluation of the fallopian tubes with ultrasound in the GYN’s office that is safer and less costly than the alternative radiology exam. About FemCath® FemCath is the first FDA-cleared product that allows for selective evaluation of the fallopian tubes by using in conjunction with FemVue. The baseline ultrasound-based diagnostic test is essential prior to any infertility treatment, including our therapeutic solution FemaSeed. About FemCerv® FemCerv is the first FDA-cleared product that allows for the ...