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Femasys Announces FemBloc® Permanent Birth Control Has Achieved MDSAP Certification, Advancing Global Market Access
-- FemBloc becomes the latest Femasys product to achieve MDSAP certification, building on a proven track record of compliance -- ATLANTA, Feb. 26, 2026 (GLOBE
About this update from Femasys Inc.
[{"type":"text","content":"-- FemBloc becomes the latest Femasys product to achieve MDSAP certification, building on a proven track record of compliance -- ATLANTA, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today that its FemBloc permanent birth control system has achieved certification under the Medical Device Single Audit Program (MDSAP). The MDSAP certification positions the Company to accelerate regulatory and commercial execution across key global markets, including the United States, Canada, Japan, Australia, and Brazil. In the U.S., FDA recognition of MDSAP reflects a high level of quality system maturity and supports regulatory readiness as the Company advances its pivotal clinical trial toward PMA submission. Internationally, the certification enhances manufacturing credibility and operational scalability, supporting ongoing commercialization in Europe and enabling more efficient market entry in additional high-value regions. Overall, MDSAP certification reduces regulatory risk, reinforces manufacturing readiness, and advances the Company’s global expansion strategy. “Achieving MDSAP certification is a significant milestone for FemBloc and expands our pathway into key international markets,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “This certification aligns FemBloc with our established, MDSAP-certified portfolio and reflects the strength of our U.S. based manufacturing platform. Importantly, it enhances our global scalability, supports future U.S. commercialization, and strengths our ability to pursue strategic partnerships as we target a substantial global market that remains both underserved and significantly underpenetrated.” Permanent birth control is one of the most widely utilized contraceptive methods worldwide, yet current options remain surgical, requiring anesthesia, abdominal incisions, and post-procedure recovery, which introduce procedural risks and increase healthcare costs. FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control designed to address this significant unmet need in women’s reproductive health. Using a patented delivery system, FemBloc places a proprietary blended polymer into both fall...