Sam Brusco, Associate Editor06.20.24
Femasys has earned European Union Medical Device Regulation (EU MDR) certification and CE mark approval for four of its women’s health products.
The four products covered in the certifications are FemaSeed, FemVue, FemCerv, and FemCath. The FemaSeed infertility treatment gained U.S. Food and Drug Administration (FDA) 510(k) clearance in 2023.
FemVue is used for assessment of fallopian tubes by ultrasound in tandem with FemCath, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv, an endocervical tissue sampler for cervical cancer diagnosis.
The company’s regulatory team finished the MDR application process in conjunction with TÜV SÜD to achieve the certification.
Femasys also recently completed the build-out of its initial commercial team in the U.S., according to founder, president, and CEO Kathy-Lee Sepsick.
“Upon receiving CE Mark approval for our portfolio of products, we can now concurrently identify strategic distribution partners to commercialize our products throughout the European Union,” Sepsick told the press. “We look forward to providing progress updates on our commercial efforts as they develop.”
The company is currently enrolling patients for its pivotal trial of FemBloc, a non-surgical, in-office, permanent form of birth control meant to be a safer option for women at a much lower cost than long-standing surgical alternatives.
Check out editor-in-chief Sean Fenske's "Medtech Matters" podcast featuring Femasys leader Kathy-Lee Sepsick here!
The four products covered in the certifications are FemaSeed, FemVue, FemCerv, and FemCath. The FemaSeed infertility treatment gained U.S. Food and Drug Administration (FDA) 510(k) clearance in 2023.
FemVue is used for assessment of fallopian tubes by ultrasound in tandem with FemCath, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv, an endocervical tissue sampler for cervical cancer diagnosis.
The company’s regulatory team finished the MDR application process in conjunction with TÜV SÜD to achieve the certification.
Femasys also recently completed the build-out of its initial commercial team in the U.S., according to founder, president, and CEO Kathy-Lee Sepsick.
“Upon receiving CE Mark approval for our portfolio of products, we can now concurrently identify strategic distribution partners to commercialize our products throughout the European Union,” Sepsick told the press. “We look forward to providing progress updates on our commercial efforts as they develop.”
The company is currently enrolling patients for its pivotal trial of FemBloc, a non-surgical, in-office, permanent form of birth control meant to be a safer option for women at a much lower cost than long-standing surgical alternatives.
Check out editor-in-chief Sean Fenske's "Medtech Matters" podcast featuring Femasys leader Kathy-Lee Sepsick here!