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Femasys Shares Rise on CE Mark & Canada Approval for FemVue MINI

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Femasys Inc. (FEMY - Free Report) has announced that it has received the CE mark certification and Health Canada approval for its latest innovation, the FemVue MINI. This compact and environmentally conscious device is designed for fallopian tube assessment, offering the same high efficacy as its predecessor with a reduced ecological footprint. This milestone marks a significant step forward in Femasys' mission to provide accessible and sustainable healthcare solutions for women.

FEMY is a leading biomedical company committed to addressing significant unmet needs in women's health through innovative, in-office therapeutic and diagnostic solutions. The company has developed a broad portfolio of products, including FemVue, the first FDA-cleared device for real-time fallopian tube evaluation via ultrasound, offering a safer and more cost-effective alternative to traditional radiology exams. Femasys' innovations extend to FDA-cleared and internationally approved products like FemaSeed Intratubal Insemination, a groundbreaking infertility treatment, and FemBloc, a non-surgical permanent birth control method that is currently in late-stage clinical development.

Shares of FEMY were up 0.9% on Aug. 30 following the announcement of the news.

Significance of Femasys’ FemVue MINI

Femasys has developed the FemVue MINI as part of its broader initiative to incorporate environmentally impactful programs. The FemVue MINI represents a critical advancement in women's reproductive health by combining cutting-edge diagnostic technology with a strong commitment to sustainability. The device's eco-friendly design reduces its environmental impact across its product lines without compromising on effectiveness, reflecting Femasys' dedication to responsible resource management. With its CE mark certification and Canadian approval, FemVue MINI is poised to improve access to advanced, eco-conscious diagnostic tools for women across Europe and Canada, setting a new standard for innovation in women's healthcare.

Market Prospects Favoring FEMY

Per a report in Market Research Future, the women's healthcare market size is estimated to be worth $8.22 billion in 2024. It is anticipated to reach $10.9 billion by 2032, at a CAGR of 3.58%.

The robust growth is driven by the increasing incidence of chronic health, rising demand for contraceptives to prevent unintended pregnancies, government initiatives to curb population growth and growing focus on new product innovations.
 

Recent Development at Femasys

In June, Femasys announced that it had obtained European Union Medical Device Regulation (EU MDR) certification and CE Mark approval for four of its products: FemaSeed, FemVue, FemCerv, and FemCath. These certifications confirm that the products meet the EU's stringent medical device standards, allowing FEMY to market them across the European Union.

FEMY Stock Price Performance

Shares of Femasys have risen 20% year to date compared with the industry’s 0.6% growth. The S&P 500 has witnessed an 18.4% rise in the same time frame.

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Zacks Rank & Key Picks

Currently, Femasys carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the broader medical space are Universal Health Services (UHS - Free Report) , Quest Diagnostics (DGX - Free Report) and ABM Industries (ABM - Free Report) . While Universal Health Services sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and ABM Industries carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Universal Health Services has an estimated long-term growth rate of 19%. UHS’ earnings surpassed estimates in each of the trailing four quarters, with the average being 14.58%.

Universal Health Services has gained 41.1% compared with the industry's 34.8% growth year to date.

Quest Diagnostics has an estimated long-term growth rate of 6.20%. DGX’s earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 3.31%.

Quest Diagnostics’ shares have risen 3.7% year to date compared with the industry’s 10.2% growth.

ABM Industries’ earnings surpassed estimates in each of the trailing four quarters, delivering an average surprise of 7.34%.

ABM's shares have risen 24.1% year to date compared with the industry’s 11.9% growth.

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