Femasys has earned CE mark and Health Canada approval for its FemVue MINI for fallopian tube assessment.
 
FemVue MINI was designed to offer the same level of efficacy as its predecessor with an eco-conscious form factor. The company aims to make a significant positive difference within women’s healthcare resource management.
 
FemVue holds the title of the first U.S. Food and Drug Administration (FDA)-cleared product that creates natural contrast to allow real-time evaluation of the fallopian tubes with ultrasound in the GYB’s office. The company said FemVue is safer and costs less than the alternative radiology exam.
 
CE mark certification and Canadian approval for FemVue MINI expands access to advanced diagnostic technology for women across Europe and Canada. The company said its development is part of a broader initiative to integrate environmentally impactful programs for its product franchises.
 
Earlier this summer, the company won EU approval for four of its women’s health products.
 
“Our mission at Femasys has always been to develop cutting-edge technology that are safe, affordable, and accessible to address critical needs in women’s health,” said Kathy Lee-Sepsick, Femasys’ founder, president, and CEO. “With the FemVue MINI, we are advancing an equally effective solution in a smaller footprint that is aligned with our initiative to be environmentally conscious demonstrating our commitment to sustainability.”

Read MPO’s interview with Kathy-Lee Sepsick in the “Medtech Matters” podcast here!