Femasys Secures CE Mark for FemHSG Catheter, Expanding European Fertility Portfolio
Event summary
- Femasys Inc. received CE Mark approval for its FemHSG Catheter on May 13, 2026.
- The catheter is designed for use with the FemVue device for in-office ultrasound-based fertility evaluation.
- Femasys aims to expand its fertility care portfolio in Europe through commercial partners.
- The company's fertility portfolio includes FemaSeed, FemVue, and FemHSG Catheter.
- FemBloc, a non-surgical permanent birth control, received full regulatory approval in Europe, the UK, and New Zealand in 2025.
The big picture
Femasys' CE Mark approval for the FemHSG Catheter strengthens its position in the European fertility care market. The company is focusing on making fertility and non-surgical permanent birth control more accessible and cost-effective. This strategic move aligns with broader industry trends towards in-office diagnostic and therapeutic solutions, potentially expanding Femasys' market reach and revenue streams.
What we're watching
- Market Penetration
- How Femasys will leverage the CE Mark approval to accelerate adoption of the FemHSG Catheter in Europe.
- Regulatory Progress
- Whether Femasys can sustain its momentum in securing regulatory approvals for its other products.
- Commercial Strategy
- The pace at which Femasys can establish and grow commercial partnerships for its fertility care portfolio.