Femasys gains CE Mark approval for women's health products [Yahoo! Finance]
Femasys Inc. (FEMY)
Company Research
Source: Yahoo! Finance
Now in compliance with the new EU legislation for medical devices, the products – FemaSeed, FemVue, FemCerv and FemCath – are developed for women's reproductive health. The latest development paves the way for the company to commence commercialisation efforts for the products within the European market. The CE Mark approval for these four products follows closely after the company received the MDR certification. Femasys' regulatory team, in collaboration with TÜV SÜD, successfully completed the MDR application process to gain this certification. Femasys founder, president and CEO Kathy Lee-Sepsick said: “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. “We recently completed the build-out of our initial commercial team in the US,
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FEMY
News
- Femasys to Participate in European Society of Human Reproduction and Embryology 40th Annual Meeting in Amsterdam [Yahoo! Finance]Yahoo! Finance
- Femasys to Participate in European Society of Human Reproduction and Embryology 40th Annual Meeting in AmsterdamGlobeNewswire
- Femasys Inc. (NASDAQ: FEMY) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $13.00 price target on the stock.MarketBeat
- 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 [Yahoo! Finance]Yahoo! Finance
- Femasys Receives CE Mark Approval for Four of its Women’s Health Products Clearing the Path for the Company to Begin Commercialization Efforts in EuropeGlobeNewswire
FEMY
Sec Filings
- 6/20/24 - Form 8-K
- 6/7/24 - Form DEF
- 5/9/24 - Form 10-Q
- FEMY's page on the SEC website