regulatory
confidence high
sentiment positive
materiality 0.75
Femasys receives FDA 510(k) clearance for FemChec fallopian tube diagnostic
FEMASYS INC
- FemChec cleared by FDA for controlled contrast delivery to check tubal status.
- FemChec is also used as confirmation test after FemBloc non-surgical permanent birth control.
- FemBloc is in late-stage FINALE pivotal trial, currently enrolling.
- FemChec uses natural contrast and ultrasound, avoiding x-ray dye and radiation exposure.
- CEO Kathy Lee-Sepsick says clearance strengthens women's health product suite.