We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Femasys Stock Rises After FDA Clearance for FemChec Diagnostic Device
Read MoreHide Full Article
Femasys Inc. (FEMY - Free Report) 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.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks
Currently, Femasys carries a Zacks Rank #4 (Sell).
Some top-ranked stocks in the broader medical space are Universal Health Services (UHS - Free Report) , Quest Diagnostics (DGX - Free Report) and Aveanna Healthcare (AVAH - Free Report) . While Universal Health Services sports a Zacks Rank #1 (Strong Buy), Quest Diagnostics and Aveanna Healthcare 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 48.6% compared with the industry's 42.7% 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 11.9% year to date compared with the industry’s 15.8% growth.
Aveanna Healthcare's earnings surpassed estimates in each of the trailing four quarters, with the average surprise being 47.5%. AVAH's shares have risen 104.5% year to date compared with the industry’s 15.7% growth.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Shutterstock
Femasys Stock Rises After FDA Clearance for FemChec Diagnostic Device
Femasys Inc. (FEMY - Free Report) 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.
Image Source: Zacks Investment Research
Zacks Rank & Key Picks