Femasys Inc. FEMY recently received 510(k) clearance from the FDA for FemChec, a diagnostic device for fallopian tube assessment. The device offers controlled delivery of contrast, confirming tubal status safely and efficiently.

Femasys has achieved U.S. FDA clearance and Canadian regulatory approval for FemChec, a diagnostic solution designed for the controlled delivery of natural contrast during ultrasound evaluations of fallopian tubes. The device uses an alternating saline and air pattern to assist in confirming tubal status. FemChec plays a key role in Femasys’ ongoing pivotal trial for FemBloc, its non-surgical permanent birth control solution, where it is used to confirm the procedure's success.

Shares of FEMY closed 1.9% higher on Sept. 9 following the news.

Significance of FDA’s Clearance for Femasys’ FemChec

The FDA clearance of FemChec reinforces the company’s commitment to advancing women’s health diagnostics. It eliminates the need for X-rays and radiology referrals, providing a radiation-free, in-office alternative for tubal assessments. FemChec is also crucial for the FemBloc non-surgical permanent birth control method by allowing procedure confirmation through natural contrast and ultrasound and contributing to safer, more accessible reproductive healthcare.

FemChec, while designed for evaluating fallopian tubes, is primarily expected to be used alongside Femasys’ FemBloc, which aids in delivering a biopolymer into fallopian tubes via balloon catheters during an in-office procedure. The biopolymer solidifies upon contact with the tissue, initiating a wound-healing response that forms scar tissue to block the tubes. As the biopolymer degrades, it is naturally expelled from the body. This innovative approach provides a non-invasive birth control solution.

Femasys continues to collaborate with the FDA as it advances the FemBloc solution through the FINALE pivotal trial.

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 3.6%.

The robust growth is likely to be 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 Developments at Femasys for Women’s Healthcare

Last month, Femasys received CE mark certification and Health Canada approval for its FemVue MINI, an eco-friendly, compact device for fallopian tube assessment. The FemVue MINI offers the same efficacy as previous models while reducing environmental impact, aligning with the company’s commitment to sustainability. These approvals will expand access to advanced diagnostic technology for women in Europe and Canada.

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 11.8% year to date against the industry’s 2.8% fall. The S&P 500 has witnessed a 13.3% rise in the same time frame.

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