The McGuireWoods Women’s Health Newsletter delivers information on the latest legal and regulatory developments affecting the women’s health industry. The publication provides timely analysis of legislative changes, regulatory updates, enforcement trends and transactional updates that may be of interest to those operating in or looking to enter into the women’s health space, including providers, investors and other stakeholders.
The legal landscape surrounding women’s health continues to evolve rapidly at the federal and state levels. From reproductive healthcare regulations and insurance coverage requirements to workplace accommodations and pharmaceutical developments, organizations across the medical care, pharmaceutical, insurance and employer sectors face an increasingly complex patchwork of legal obligations.
Each edition of this publication will highlight significant legal updates, offer practical compliance considerations and identify emerging issues that warrant attention, while giving a snapshot of the current landscape.
Transactions and Investments
Budding Investment Epicenter
According to research conducted by diagnostics company AOA Dx, women’s health exits surpassed $100 billion in acquisitions and IPOs in the past 25 years. Anna Jeter, co-founder of AOA Dx, led the research, which was released at the JPMorgan Healthcare Conference on Jan. 13, 2026. According to the report, since 2020, the women’s health market amassed $34 billion in private investment. Diagnostic testing, particularly in cancer screening and molecular testing, is experiencing particularly persistent market success. This meteoric growth in the sector can be attributed to the increased acknowledgement and increased focus on conditions that disproportionately affect women.
Xella Health
Xella Health, a women’s precision health startup headquartered in San Francisco, closed over $3.7 million in pre-seed financing led by Precursor Ventures, with participation from Capital F, Ulu Ventures and other investors. The company announced its plans to use the funds to launch its multi-omic diagnostics platform to provide insights into fertility, hormonal health and preventative care in spring 2026.
Hologic
Hologic, a medical diagnostics company specializing in breast and cervical cancer screening and infectious disease testing, agreed to be acquired by private equity firms Blackstone and TPG in a deal valued at up to $18.3 billion. Hologic has indicated that this partnership will “enhance [Hologic’s] ability to deliver critical medical technologies to customers and their patients around the world” and add immediate and compelling value to Hologic stockholders.
Increased Investments in Femtech
In December 2025, several femtech startups secured funding, with notable raises including Inito’s $29 million Series B for at-home hormone testing, AngelEye Health’s $9 million Series C for neonatal care technology, and Biologica’s $7 million seed round for women’s health supplements. The femtech market is experiencing explosive growth due to increased awareness of gaps in traditional healthcare for women, more women in VC decision-making roles, diagnostic advancements and an underserved market, which is projected to attain a valuation of $266.99 billion at a CAGR of 15.51% during the forecast period of 2026 to 2035. The hottest sectors attracting investment include reproductive health and fertility (such as IVF and hormone tracking), menopause solutions, maternal health technology and AI-powered diagnostics.
Pomelo
Pomelo Care, a virtual maternity care company headquartered in New York, announced a $92 million Series C financing round, bringing the company’s valuation to $1.7 billion. The round was led by Stripes, with participation from Andreessen Horowitz. Founded in 2021, Pomelo Care delivers comprehensive, technology-enabled maternity care through a virtual platform that connects expecting and new parents with a broad range of healthcare providers. The company partners with health plans and employers to offer holistic support throughout pregnancy, delivery and postpartum recovery, covering over 25 million lives and nearly 7% of all births in the United States. Pomelo Care’s care model demonstrated significant clinical and cost outcomes. The company reports a 37% reduction in preterm births among its members, a 46% reduction in emergency room visits and a 6.8-day reduction in neonatal intensive care unit stays. With the new capital, Pomelo Care plans to accelerate growth by expanding its platform into menopause care and broader reproductive health services, extending its mission to support women across more stages of life.
Regulatory and Enforcement
TrumpRx
The current administration made lowering drug prices a policy priority, and a key vehicle for this initiative is TrumpRx.gov. The website does not sell drugs directly but serves as a portal for the public to search for a prescription medication and determine whether it is available through a cost-saving program offered by a pharmaceutical manufacturer’s own direct-to-consumer website. If the drug is part of such a program, consumers will be redirected to the manufacturer’s webpage, where they can purchase the drug directly using a cash-based payment system rather than through their insurance. At least 15 major drug companies have signed agreements to participate in the program. Among the medications available are several fertility treatments for which patients can save on their monthly costs. The platform also offers menopause medications. McGuireWoods discussed TrumpRx and its connections to the Anti-Kickback Statute in a previous alert.
Medicare Deactivation
McGuireWoods recently discussed the increasing risk of Medicare billing privileges deactivations, which occur when providers and suppliers fail to timely update, revalidate or respond to development requests from Medicare Administrative Contractors (MACs), resulting in permanent lost revenue during the deactivation period. The authors note that MACs have become increasingly aggressive in scrutinizing CMS Form 855 enrollment applications and supporting documentation, often imposing deactivations for minor discrepancies. To avoid deactivation, providers should promptly respond to revalidation and development requests, report changes to enrollment information within required timeframes, and confirm with MACs that all submissions have been received. If deactivation does occur, providers should immediately submit a new enrollment application to minimize billing gaps and engage legal counsel to submit a rebuttal within the 15-day deadline, while also preserving administrative remedies.
Botox Fraud Scheme
A federal grand jury in California recently indicted a physician for allegedly submitting more than $45 million in false and fraudulent claims to Medicare for botulinum toxin (Botox) injections. The physician was accused of billing Medicare for Botox injections that were medically unnecessary and were never provided, submitting claims for procedures performed on dates when the physician was traveling internationally, when beneficiaries were traveling internationally and when the clinic was closed. Further, the physician allegedly falsified the records to reflect that the beneficiaries suffered from chronic migraines, an on-label covered use of Botox, when they did not. If convicted, the physician faces a maximum penalty of 20 years in prison for each of the nine counts of wire fraud and five years in prison for each of the three counts of obstructing a criminal investigation of healthcare offenses. It is important for providers and MSOs to conduct routine audits of medical records to ensure services billed were medically necessary and dates of services are accurate.
Proposed Update to Washington Material Transaction Notice Law
The Washington Legislature became the latest to consider strengthening its corporate practice of medicine rules to address private equity investment in healthcare practice. Second Substitute Senate Bill 5387 (2SSB 5387) would require healthcare providers licensed in Washington to hold a majority of each class of voting shares in professional organizations, constitute a majority of the board of directors, and hold all officer positions except secretary and treasurer. The licensed shareholders must also demonstrate “meaningful ownership” by being “substantially engaged” in delivering care or managing the practice instead of merely owning nominal stock. The bill also prohibits shareholders, directors and officers of healthcare practices from simultaneously participating in a contracted management services organization — a common structure used in private equity-backed practice affiliations — as an owner, director, officer, employee or contractor. The proposed penalties include disciplinary action against healthcare providers, civil fines up to $1,000 per day and criminal penalties that would escalate from gross misdemeanor charges for first offenses to Class C felony charges for subsequent violations. If enacted, this bill would take effect on Jan. 1, 2027.
‘Black Box’ Warning Removed from Hormone Replacement Therapies
On Feb. 12, 2026, the FDA announced the approval of labeling changes to six hormone replacement therapy products that removed the boxed warning relating to cardiovascular disease, breast cancer and dementia. The FDA initiated the review in November 2025, when the agency indicated that the scientific evidence no longer supported the inclusion of the warnings and advised pharmaceutical companies to submit labeling changes to reflect the current evidence and clarify the benefit/risk considerations for these therapies. The labeling changes caused a surge in prescriptions for hormone therapy products, straining an already weakened supply chain, and resulting in reports of shortages.
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McGuireWoods looks forward to serving as your trusted partner in this dynamic area of law. For questions about how these developments could affect your business or to discuss strategies for addressing the challenges and opportunities they present, contact the authors or a member of the Healthcare Compliance, Regulatory & Policy and the Healthcare Transactions & Finance Practice Groups.
For additional insights on women’s healthcare topics, refer to the following alerts:
Maternal Health: Where Mission Meets Margin in a Transforming Market (January 7, 2026)
Unlocking Opportunities at the Intersection of Women’s Health, Wellness and Medical Aesthetics (Sept. 24, 2025)
The Next Frontier: Navigating the Menopause and Midlife Women’s Health Market (Sept. 15, 2025)
The Fertility Economy: Where Science Meets Market Demand (Sept. 4, 2025)
From Delivery to Recovery: Unlocking Value in Postpartum Health (Aug. 27, 2025)
Frontiers in Women’s Health: Where Investor Opportunities Meet Unmet Need (Aug. 19, 2025)