---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-039138"
form_type: "8-K"
ticker: "FEMY"
cik: "0001339005"
company_name: "FEMASYS INC"
filed_at: "2024-08-29T23:59:59+00:00"
generated_at: "2026-05-31T06:57:54.473712+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.55
calibrated_materiality_score: 0.55
confidence: "high"
source: SEC EDGAR
---

# Femasys receives CE Mark and Health Canada approval for FemVue MINI fallopian tube assessment

## Summary
- CE Mark certification obtained for FemVue MINI, enabling sales in European Economic Area.
- Health Canada granted product approval for FemVue MINI, opening Canadian market.
- FemVue MINI is a compact, eco-friendly version of existing FemVue diagnostic product.
- CEO Kathy Lee-Sepsick cites expanded access to advanced women's health diagnostics in Europe and Canada.
- Product designed with smaller environmental footprint, supporting company sustainability initiatives.

## SEC filing metadata
- accession: 0001140361-24-039138
- form_type: 8-K
- ticker: FEMY
- cik: 0001339005
- company_name: FEMASYS INC
- filed_at: 2024-08-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.55
- calibrated_materiality_score: 0.55
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1339005/000114036124039138/0001140361-24-039138-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1339005/000114036124039138/ef20035123_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-039138
- JSON: https://secwatch.observer/filing/0001140361-24-039138.json
- Plain text: https://secwatch.observer/filing/0001140361-24-039138.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.