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Femasys Gains FDA Clearance for FemVue Diagnostic Device

Story Highlights
  • Femasys received FDA 510(k) clearance for its FemVue Controlled device.
  • The next-generation FemVue Controlled integrates FemVue and FemChec technologies, improving clinical and manufacturing efficiency.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Femasys Gains FDA Clearance for FemVue Diagnostic Device

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Femasys ( (FEMY) ) has provided an announcement.

On December 18, 2025, Femasys Inc. reported that it had received 510(k) clearance from the U.S. Food and Drug Administration for its FemVue Controlled diagnostic device, a next-generation solution for controlled contrast delivery during ultrasound imaging to evaluate fallopian tube status. The device combines features of the company’s original FemVue and FemChec technologies into a single FDA-cleared platform, supporting multiple clinical uses such as confirming tubal patency before FemaSeed procedures and is intended to simplify care delivery, enhance workflow efficiency in clinical practice, and streamline manufacturing as Femasys expands its integrated fertility and women’s health product portfolio.

The most recent analyst rating on (FEMY) stock is a Hold with a $0.82 price target. To see the full list of analyst forecasts on Femasys stock, see the FEMY Stock Forecast page.

Spark’s Take on FEMY Stock

According to Spark, TipRanks’ AI Analyst, FEMY is a Neutral.

Femasys’s overall stock score is primarily influenced by its challenging financial performance, which poses significant risks. However, recent corporate events, including a major order and FDA approval, provide positive momentum and potential growth opportunities. Technical analysis shows mixed signals, and valuation metrics are weak, reflecting the speculative nature of the stock.

To see Spark’s full report on FEMY stock, click here.

More about Femasys

Femasys Inc., listed on Nasdaq as FEMY, is a U.S.-based biomedical innovator focused on making fertility treatments and non-surgical permanent birth control more accessible and cost-effective for women worldwide. The company manufactures in-office therapeutic and diagnostic products, including the FemaSeed intratubal insemination system, the FemVue diagnostic for fallopian tube assessment, and the FemBloc non-surgical permanent contraceptive, which secured regulatory approvals in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025, with commercialization in select European markets pursued through strategic partnerships.

Average Trading Volume: 8,085,214

Technical Sentiment Signal: Sell

Current Market Cap: $49.92M

For a thorough assessment of FEMY stock, go to TipRanks’ Stock Analysis page.

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