Femasys Secures U.S. FDA Clearance for Next-Generation FemVue Diagnostic Device
Rhea-AI Summary
Femasys (NASDAQ: FEMY) announced U.S. FDA 510(k) clearance on December 18, 2025 for its next‑generation FemVue Controlled diagnostic device.
The single‑device solution combines the company’s original FemVue and FemChec technologies to provide controlled contrast delivery for fallopian tube evaluation, support multiple clinical uses, and streamline manufacturing and practice workflows. Management said the clearance advances clinician‑focused innovations and aims to strengthen the scalability and efficiency of the product portfolio.
Positive
- FDA 510(k) clearance received on December 18, 2025
- Integration of FemVue and FemChec into one device
- Designed for controlled contrast delivery to evaluate fallopian tubes
- Aims to streamline manufacturing and clinical workflows
- Multiple clinical uses enabled by a single FDA‑cleared product
- Portfolio scalability and efficiency expected to improve
Negative
- None.
Key Figures
Market Reality Check
Peers on Argus 1 Up
Pre-news, peers were mixed: moves ranged from -27.18% (MHUA) to +9% (HBIO), while only one momentum peer (GCTK) showed an ~6.09% upside move, suggesting company-specific dynamics around FEMY.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 14 | Earnings & update | Positive | +8.6% | 3Q 2025 results plus FDA IDE approval and multiple global milestones. |
| Nov 10 | Commercial order | Positive | +0.0% | Approximate $500,000 FemBloc launch order in France and Benelux. |
| Nov 03 | FDA & financing | Positive | +3.1% | FDA IDE approval for FemBloc trial and $12M secured convertible notes. |
| Oct 22 | Clinical study start | Positive | -9.6% | Initiation of FemBloc post-market surveillance study under EU MDR. |
| Oct 16 | Conference showcase | Positive | +35.4% | Showcasing FemaSeed ITI at ASRM 2025 with strong pregnancy rate data. |
Recent FEMY news has often been positive, with three of five events producing aligned price gains but two showing divergence, including a notable selloff on favorable clinical progress.
Over the last few months, Femasys reported multiple milestones, including FDA IDE approval to advance the final FemBloc pivotal trial and related $12 million financing with potential to reach $58 million (Nov 3). Subsequent updates highlighted European FemBloc commercialization, a post‑market surveillance study under EU MDR (Oct 22), and strong interest around FemaSeed at ASRM 2025 with a 35.38% price reaction (Oct 16). The new FemVue 510(k) clearance adds another regulatory milestone to this sequence of product-focused developments.
Regulatory & Risk Context
Femasys has an active Form S-3 shelf filed on 2025-07-03 that remains effective until 2028-07-03. It is currently marked as not effective for use and shows 0 recorded usages, indicating no takedowns have been executed under this shelf yet.
Market Pulse Summary
This announcement adds another FDA milestone, with 510(k) clearance for the FemVue Controlled diagnostic device integrating existing FemVue and FemChec technologies. It follows recent IDE approval for the final FemBloc pivotal phase, multiple financings totaling at least $12 million, and growing European activity. Investors may watch future updates on commercial uptake for FemVue Controlled, progression of the FemBloc program, and how the company utilizes its balance sheet and registration shelf to support ongoing development and commercialization plans.
Key Terms
510(k) clearance regulatory
Food and Drug Administration (FDA) regulatory
AI-generated analysis. Not financial advice.
-- Innovative single-device solution integrates proven FemVue and FemChec® technologies to support fallopian tube evaluation and improve workflow efficiency--
ATLANTA, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its FemVue Controlled device, an innovative diagnostic solution designed for controlled contrast delivery to evaluate fallopian tube status. The next-generation FemVue Controlled device integrates features of the Company’s original FemVue and FemChec technologies into a single FDA-cleared product, enabling multiple clinical uses while streamlining manufacturing and practice workflows.
“This FDA clearance represents an important milestone for Femasys as we continue to advance practical, clinician-focused innovations,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “FemVue Controlled reflects our commitment to simplifying care delivery while strengthening the scalability and efficiency of our product portfolio.”
About FemVue Controlled
FemVue® Controlled is an FDA-cleared diagnostic device designed for controlled delivery of a consistent alternating pattern of saline and air as contrast media during ultrasound imaging to evaluate fallopian tube status. The next-generation device integrates features of the Company’s FemVue and FemChec® technologies into a single platform, enabling multiple clinical uses within one solution, including confirmation of tubal patency prior to use with FemaSeed®. Learn more at www.FemVue.com.
About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed® Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1
FemBloc® permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.
Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
References
1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.
2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B., Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.
Forward-Looking Statements
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “suggests,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2024, and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
Contacts:
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com
FAQ
What did Femasys (FEMY) announce on December 18, 2025?
What is the purpose of the FemVue Controlled device from FEMY?
How does FemVue Controlled differ from prior Femasys products?
Will the FDA clearance affect Femasys product workflows?
Is FemVue Controlled cleared for clinical use in the U.S.?
