Femasys, a biomedical company focused on women’s health, has announced receiving European Union Medical Device Regulation (EU MDR) and CE Mark certification for four of its products. The approved products—FemaSeed, FemVue, FemCerv, and FemCath—comply with the latest EU medical device regulations, marking a significant step for Femasys as it prepares to enter the European market. This achievement follows the recent completion of their initial commercial team build-out in the United States, emphasizing Femasys’ commitment to expanding its reach and delivering innovative solutions for women’s reproductive health globally.
Kathy Lee-Sepsick, Femasys’ Founder, President, and CEO, commented: “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.” With the regulatory approval in hand, Femasys is now poised to identify strategic distribution partners to commercialize their products throughout the European Union, alongside their primary marketing efforts in the United States.
The EU MDR certification is a rigorous process designed to ensure high standards of clinical safety and market access fairness. It encompasses the entire lifecycle of medical products and processes, making Femasys’ recent CE Mark approval a testament to their quality and compliance. The certification process was completed in conjunction with TÜV SÜD, a global provider of testing and product certification, underscoring the robust testing and quality assurance measures that Femasys products have undergone.
Femasys Inc. is at the forefront of developing innovative therapeutic and diagnostic solutions to address significant unmet needs in women’s health. Their portfolio includes the FDA-cleared FemaSeed Intratubal Insemination, an advanced infertility treatment designed to deliver sperm directly to the site of conception. This product is not only FDA-cleared but has also received regulatory approval in Canada and Europe. Another significant product in their pipeline is FemBloc, currently in late-stage clinical development. FemBloc is a non-surgical, in-office, permanent birth control method, intended to be a safer and more cost-effective alternative to traditional surgical options.
In addition to their therapeutic innovations, Femasys has developed several diagnostic products that are ready for commercialization, thanks to their in-house manufacturing capabilities. These include FemVue, a unique ultrasound-based system for assessing fallopian tube patency, which can be used in conjunction with FemCath, an intrauterine catheter designed for selective evaluation of the fallopian tubes. FemCerv, an endocervical tissue sampler used for cervical cancer diagnosis, provides a minimally invasive method for obtaining diagnostic tissue samples.
