RegulatoryMay 13, 2026, 09:02 AM
Femasys Receives CE Mark for FemHSG™ Catheter
AI Summary
Femasys Inc. announced it has received CE Mark approval for its FemHSG™ Catheter, which will further expand the company's product portfolio in Europe through commercial partners. The FemHSG Catheter, designed for use with the FemVue device, supports efficient in-office ultrasound-based evaluation during the initial fertility workup. This approval is expected to improve access to timely and affordable fertility diagnosis and intervention for women worldwide, strengthening Femasys' growing fertility offerings.
Key Highlights
- Femasys received CE Mark approval for its FemHSG™ Catheter, expanding its portfolio in Europe.
- The FemHSG Catheter is used with the FemVue device for in-office ultrasound-based fertility evaluation.
- The approval aims to improve access to timely, affordable fertility diagnosis and intervention.
- FemaSeed® is the company's first-line fertility treatment, offering cost-effective intervention.
- FemBloc® received full regulatory approval in Europe (June 2025), UK (August 2025), and New Zealand (September 2025).
- Enrollment in the FINALE pivotal trial (NCT05977751) for FemBloc® US FDA approval is ongoing.
Price Impact
More from FEMY