Femasys Receives FDA 510(k) Clearance for FemVue Controlled Device
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 18 2025
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Femasys announced 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. "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. "FemVue Controlled reflects our commitment to simplifying care delivery while strengthening the scalability and efficiency of our product portfolio."
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Analyst Views on FEMY
Wall Street analysts forecast FEMY stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for FEMY is 4.75 USD with a low forecast of 3.00 USD and a high forecast of 6.50 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.587
Low
3.00
Averages
4.75
High
6.50
Current: 0.587
Low
3.00
Averages
4.75
High
6.50
About FEMY
Femasys Inc. is a biomedical company. The Company is focused on addressing the unmet needs of women worldwide with a broad portfolio of in-office, accessible, and therapeutic and diagnostic solutions. The Company has two lead product candidates: FemBloc and FemaSeed. FemBloc is a permanent birth control solution in development. Its permanent birth control solution in development includes its FemBloc system, which features dual intrauterine directional delivery targeting both fallopian tubes with a degradable blended biopolymer. FemaSeed is an artificial insemination infertility treatment. Its artificial insemination solution in development includes its FemaSeed product candidate for artificial insemination, which features single intrauterine directional delivery. It also developed FemCerv, which is an endocervical tissue sampler for cervical cancer diagnosis; FemVue, which is a companion diagnostic for fallopian tube assessment; FemCath, which is an intrauterine catheter, and FemChec.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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Femasys (FEMY) Receives Nasdaq Approval for 180-Day Compliance Extension Until July 2026
- Compliance Extension: Femasys has received Nasdaq approval for a 180-day extension until July 13, 2026, to meet the minimum closing bid price requirement of $1.00 per share, ensuring the company's continued listing status on the capital market.
- Stable Listing Status: The extension notice does not immediately affect Femasys's listing status on Nasdaq, indicating the company's resilience and operational capability amid market challenges.
- Market Reaction: FEMY shares fell 0.81% in premarket trading to $0.5809, reflecting cautious investor sentiment regarding the company's compliance progress, which may impact future financing and market confidence.
- Financing Context: Recently, Femasys secured $12 million in financing and received FDA approval for the final FemBloc trial, demonstrating positive advancements in product development and fundraising despite compliance pressures.
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