Femasys Inc. announced that its FemBloc permanent birth control system has received certification under the Medical Device Single Audit Program (MDSAP) as of February 26, 2026. The certification confirms that FemBloc meets the quality and regulatory requirements of the U.S. Food and Drug Administration, the European Medicines Agency, Health Canada, Japan’s MHLW/PMDA, Australia’s TGA, and Brazil’s ANVISA.
MDSAP allows a single audit to satisfy the regulatory requirements of multiple countries, reducing duplication and accelerating market entry. By achieving MDSAP certification, FemBloc can streamline future audits in key markets and position itself for additional regulatory clearances in emerging markets that recognize the program.
The certification is a strategic milestone that supports Femasys’s plan to commercialize FemBloc worldwide. It strengthens the company’s global scalability, supports future U.S. commercialization, and enhances the ability to pursue strategic partnerships. The certification also aligns FemBloc with the company’s established MDSAP‑certified portfolio and reflects the strength of its U.S. manufacturing platform.
Femasys has faced financial challenges in recent quarters. In Q4 2024 the company reported a loss of $0.23 per share and revenue of $0.58 million, missing revenue estimates by 41.8%. In Q3 2025 the loss narrowed to $0.16 per share on revenue of $469,000. As of February 24, 2026, the company’s debt‑to‑equity ratio stood at 4.40 and its current ratio was 0.93, indicating tight liquidity and elevated financial risk. The company has also secured an FDA 510(k) clearance for its FemVue device, expanded European commercial operations for FemBloc and FemaSeed, and obtained an AMA Category III CPT code for FemaSeed effective January 1, 2027.
CEO and founder Kathy Lee‑Sepsick said, “Achieving MDSAP certification is a significant milestone for FemBloc and expands our pathway into key international markets. 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.”
The announcement was met with a positive market reaction, with analysts noting the certification’s potential to accelerate global commercialization and reduce regulatory costs.
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