Femasys Announces FemBloc Delivery System Approval in Europe; A Significant Step Towards FemBloc Permanent Birth Control Availability as the First-Ever Non-Surgical Approach [Yahoo! Financ...
Femasys Inc. (FEMY)
Company Research
Source: Yahoo! Finance
ATLANTA, March 13, 2025 (GLOBE NEWSWIRE) -- Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR) as the first regulatory approval in the world for the FemBloc ® delivery system for non-surgical female permanent birth control. For the FemBloc blended polymer, an integral part of the FemBloc permanent birth control, the Company has successfully completed an expedited G12 Special MDR Audit for Class III devices and the Notified Body has recommended for CE mark approval pending the final stages of European Medical Agency (EMA) review, with potential approval expected mid-2025. “European approval for the FemBloc delivery system was achieved through interactive collaboration with the Notified Body to accelerate t
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FEMY
News
- Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic DeviceGlobeNewswire
- Femasys (NASDAQ:FEMY) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=FEMY&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> frMarketBeat
- Femasys (NASDAQ:FEMY) is now covered by analysts at Laidlaw. They set a "buy" rating and a $6.50 price target on the stock.MarketBeat
- Femasys GAAP EPS of -$0.10, revenue of $729M [Seeking Alpha]Seeking Alpha
- Femasys Announces Third Quarter Financial Results for 2025 [Yahoo! Finance]Yahoo! Finance
FEMY
Sec Filings
- 12/18/25 - Form 8-K
- 12/10/25 - Form EFFECT
- 12/4/25 - Form S-3/A
- FEMY's page on the SEC website