Business
Femasys Receives CE Mark Approval for Four of its Women’s Health Products Clearing the Path for the Company to Begin Commercialization Efforts in Europe
ATLANTA, June 20, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women
About this update from Femasys Inc.
[{"type":"text","content":"ATLANTA, June 20, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, announces it has received its European Union Medical Device Regulation (EU MDR) certificate and CE Mark certification for four of its products. The four products – FemaSeed®, FemVue®, FemCerv®, and FemCath® – are compliant with the new European Union legislation for medical devices. The MDR certification and the four CE Mark product approvals allow Femasys to deliver its innovative solutions for women’s reproductive health within the EU market. “The CE Mark, which follows MDR certification, provides regulatory approval for us to begin marketing four of our products in the European Union. Further, it serves as independent validation of Femasys’ commitment to the highest standards of quality and safety for our customers and their patients,” said Kathy Lee-Sepsick, Femasys’ Founder, President, and CEO. “We recently completed the build-out of our initial commercial team in the United States, the focus of our primary marketing efforts. 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. We look forward to providing progress updates on our commercial efforts as they develop.” MDR certification is the regulatory precursor to receiving the EU CE Mark, which is regulatory approval in the region. The MDR includes stringent standards and requirements in both clinical and post-market areas. The regulation is intended to create a robust, transparent, sustainable, and internationally recognized regulatory framework for improved clinical safety and fair market access for manufacturers. It ensures alignment among European Union member states and is applicable for the entire lifecycle of the products and the processes supporting the delivery of Femasys’ solutions. The Company received CE Mark approval for four of its products directly on the heels of receiving the MDR certification. Femasys’ regulatory team completed the MDR application process in conjunction with TÜV SÜD to gain certification. TÜV SÜD enables access to global markets and manages ...