Welcome to our dedicated page for FEMASYS news (Ticker: FEMY), a resource for investors and traders seeking the latest updates and insights on FEMASYS stock.
Femasys Inc. (NASDAQ: FEMY) generates frequent news flow as a biomedical company focused on women’s reproductive health, fertility treatment and non-surgical permanent birth control. News updates commonly highlight progress across its product portfolio, including FemaSeed Intratubal Insemination, FemVue and FemVue Controlled diagnostic devices, FemBloc permanent birth control, and the FemChec diagnostic product.
Investors following FEMY news can expect coverage of regulatory milestones, such as U.S. FDA 510(k) clearance for FemVue Controlled and Investigational Device Exemption approval to advance the final phase of the FINALE pivotal trial for FemBloc. Company announcements also report international approvals for FemBloc in Europe, the UK and New Zealand, as well as the launch of post-market surveillance studies under EU Medical Device Regulation.
Femasys news releases frequently describe commercialization developments, including partnerships with distributors like Kebomed to expand FemBloc access in France and the Benelux region, initial commercial orders in European markets, and collaborations with healthcare providers such as Refuah Health Center to offer FemaSeed as a first-line infertility treatment in community-based care. Financial and capital markets updates, including quarterly results, underwritten offerings, and private placements of senior secured convertible notes and warrants, are also disclosed through press releases and related SEC filings.
This FEMY news page aggregates these updates in one place, making it easier to track clinical progress, regulatory events, commercialization agreements, and listing-related notices from Nasdaq. Readers can use this feed to review how Femasys is executing on its women’s health strategy and how new information may relate to the company’s fertility and permanent birth control portfolio over time.
Femasys (NASDAQ: FEMY) appointed John Canning as Chief Operating Officer effective April 1, 2026. Mr. Canning brings over 25 years of medical device operations and technology leadership to support commercialization of FemBloc and FemaSeed.
The company granted a 150,000-share inducement option, vesting 25% after one year and quarterly annual vesting thereafter, approved under Nasdaq Listing Rule 5635(c)(4).
Femasys (NASDAQ: FEMY) reported 2025 results and corporate progress on March 31, 2026. Sales rose 40.8% to $2,293,313, driven by FemBloc, while net loss was $18,627,887 (−$0.47 per share). Cash and cash equivalents were approximately $9.3 million, expected to fund operations into Q3 2026.
Key operational milestones include initiation of patient enrollment in the FINALE pivotal trial for FemBloc, FDA 510(k) clearance for FemVue, MDSAP certification for FemBloc, AMA Category III CPT code for FemaSeed, a $12 million financing, and a Switzerland distribution partnership.
Femasys (NASDAQ: FEMY) appointed Dr. Kenneth D. Eichenbaum to its board on March 18, 2026. Dr. Eichenbaum is a board-certified anesthesiologist with over 20 years evaluating biotech and medical device companies, and holds degrees from Icahn School of Medicine, University of Pennsylvania, and Wharton.
The company thanked Joshua Silverman for his board service and highlighted Dr. Eichenbaum’s clinical, engineering, and finance expertise as strategic support for Femasys’ growth in women’s reproductive health.
Femasys (NASDAQ: FEMY) has begun patient enrollment in the FDA-authorized FINALE pivotal trial of FemBloc, a first-of-its-kind non-surgical permanent birth control. The move follows an FDA Investigational Device Exemption approval and positive earlier clinical data. FemBloc is already approved and commercialized in Europe and select countries outside the U.S., and completion of FINALE is expected to support a future U.S. regulatory submission.
Femasys (NASDAQ: FEMY) announced that its FemBloc permanent birth control system achieved MDSAP certification on Feb. 26, 2026, enabling accelerated regulatory and commercial execution across the United States, Canada, Japan, Australia, and Brazil. The certification supports pivotal trial readiness toward a future PMA submission and strengthens manufacturing credibility for global expansion.
Femasys (NASDAQ: FEMY) received AMA CPT Editorial Panel approval for a new, unique Category III CPT code covering FemaSeed intratubal insemination (ITI). The code is expected to be issued publicly with an effective date of January 1, 2027.
This coding approval advances the company’s U.S. reimbursement strategy to support broader clinical adoption, provider rollout with the FemSperm product line, and expanded patient access; FemaSeed’s pivotal trial (NCT0468847) showed >2x pregnancy rates versus IUI. FemaSeed is authorized for use in the U.S., Europe, UK, Canada, and Israel.
Femasys (NASDAQ: FEMY) expanded its European commercial footprint by signing a distribution agreement with OR Consulting to launch FemBloc permanent birth control, FemaSeed intratubal insemination, and other fertility and women’s diagnostic products in Switzerland. This follows recent market entry in Spain and ongoing launches in France as part of the company’s Europe expansion strategy.
Femasys (NASDAQ: FEMY) said Nasdaq granted a 180-calendar day extension on January 13, 2026 to regain compliance with the minimum $1.00 bid price requirement.
The company has until July 13, 2026 to achieve a closing bid of $1.00 or higher for at least ten consecutive business days to regain compliance. Nasdaq noted Femasys meets the market value of publicly held shares and other initial listing requirements, except the bid price rule. Femasys said it may effect a reverse stock split, if necessary, and will monitor its share price and take actions within the prescribed period to regain compliance.
Femasys (NASDAQ: FEMY) announced a partnership with Refuah Health Center on Jan 13, 2026 to offer FemaSeed as a first-line step in infertility treatment within community-based care.
The agreement aims to expand patient access, strengthen Femasys' commercial footprint in community fertility care, and accelerate adoption by leveraging Refuah's patient engagement and care model.
Femasys (NASDAQ: FEMY) announced U.S. FDA 510(k) clearance on December 18, 2025 for its next‑generation FemVue Controlled diagnostic device.
The single‑device solution combines the company’s original FemVue and FemChec technologies to provide controlled contrast delivery for fallopian tube evaluation, support multiple clinical uses, and streamline manufacturing and practice workflows. Management said the clearance advances clinician‑focused innovations and aims to strengthen the scalability and efficiency of the product portfolio.