Femasys Obtains FDA Approval for Advanced FemVue Diagnostic Device
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 18 2025
0mins
Source: Yahoo Finance
FDA Clearance Announcement: Femasys Inc. has received FDA 510(k) clearance for its FemVue Controlled device, which integrates FemVue and FemChec technologies to enhance fallopian tube evaluation and improve clinical workflows.
Device Functionality: The FemVue Controlled device is designed for controlled delivery of saline and air as contrast media during ultrasound imaging, allowing for multiple clinical applications, including confirming tubal patency.
Company's Commitment: CEO Kathy Lee-Sepsick emphasized that this clearance marks a significant milestone in Femasys' mission to provide practical, clinician-focused innovations that simplify care delivery and enhance product efficiency.
Broader Product Portfolio: Femasys is focused on making fertility and non-surgical permanent birth control more accessible, with products like FemaSeed for infertility treatment and FemBloc for non-surgical sterilization, both demonstrating high effectiveness and patient satisfaction.
Get Free Real-Time Notifications for Any Stock
Monitor tickers like FEMY with instant alerts to capture every critical market movement.
Sign up for free to build your custom watchlist and receive professional-grade stock notifications.
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.
Atossa Therapeutics Receives FDA Orphan Drug Designation, Stock Rises Nearly 13%
- FDA Orphan Drug Designation: Atossa Therapeutics (ATOS) announced that its (Z)-endoxifen received Orphan Drug Designation from the FDA, leading to a 12.98% stock increase to $0.69, marking a significant milestone in the treatment of Duchenne muscular dystrophy and expected to drive future R&D progress.
- Clinical Trial Progress: ImmunityBio (IBRX) reported that over 85% of the study population has been enrolled in its registrational trial QUILT-2.005 for BCG-naïve non-muscle-invasive bladder cancer, with stock rising 9.43% to $6.04, and full enrollment anticipated by Q2 2026, enhancing market confidence.
- NASDAQ Compliance Extension: Femasys (FEMY) received NASDAQ approval for a 180-day extension to meet the minimum $1.00 bid price requirement, with stock climbing 10.68% to $0.72, providing the company until July 13, 2026, to regain compliance, alleviating investor concerns.
- Successful Financing: Foghorn Therapeutics (FHTX) closed a $50 million registered direct financing at a 30% premium, resulting in a 4.02% stock increase to $6.26, demonstrating market confidence and support for its future development.
Continue Reading
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.
Continue Reading