Femasys Secures CE Mark Approval for FemHSG Catheter to Expand European Portfolio
FEMY•Femasys secured CE Mark approval for its FemHSG Catheter, enabling commercial sale across Europe through its partners. The FemHSG Catheter integrates with the FemVue system for in-office ultrasound-based fertility evaluation, streamlining diagnostic workups by accommodating varying uterine cavity sizes without catheter exchange.
1. CE Mark Approval for FemHSG Catheter
On May 13, 2026, Femasys announced that its FemHSG Catheter received CE Mark approval, meeting European regulatory standards for fertility diagnostics. This approval allows the catheter to be marketed and sold across the European Economic Area through the company's established distribution channels.
2. Product Design and Integration
The FemHSG Catheter features a small-profile design with an adjustable larger balloon to accommodate varying uterine cavity sizes without exchange. It is intended for use with the FemVue ultrasound device to enable comprehensive in-office assessment of the uterus and fallopian tubes.
3. Strategic Portfolio Expansion
This regulatory milestone broadens Femasys’ fertility portfolio in Europe, complementing existing products such as FemVue and FemaSeed. It positions the company to offer a full diagnostic and treatment pathway from initial evaluation to first-line intervention.
4. Commercial and Market Implications
With CE Mark in hand, Femasys plans to leverage partnerships with OB/GYN practitioners and commercial distributors to integrate the FemHSG Catheter into routine fertility workups. The company anticipates this addition will drive adoption of its in-office fertility solutions and support revenue growth in key international markets.
