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Industry Landscape
The Women's Health industry is experiencing significant growth, driven by increasing awareness of women's specific health needs, technological advancements, and a demand for less invasive treatment options. Investment in R&D is high, focusing on solutions for infertility, contraception, and early cancer diagnostics. Regulatory landscapes are evolving, with a global push for accessible and innovative healthcare solutions.
Total Assets Under Management (AUM)
Women's Health Market Size in United States
~30.5 billion USD (2022) for North America Women's Health Diagnostics Market
(8.5% CAGR)
- Increasing prevalence of chronic diseases in women.
- Growing awareness about early diagnosis and treatment.
- Technological advancements in diagnostic devices.
Total Addressable Market
60.4 billion USD
Market Growth Stage
Pace of Market Growth
Emerging Technologies
AI-Powered Diagnostics
AI and machine learning are being integrated into diagnostic tools to improve accuracy, speed, and early detection of gynecological conditions and cancers, potentially offering more personalized and predictive healthcare.
Personalized Reproductive Medicine
Advances in genomics, proteomics, and epigenetics are enabling highly personalized approaches to fertility treatments, contraception, and overall reproductive health management, moving beyond one-size-fits-all solutions.
Non-Invasive Monitoring & Delivery Systems
Development of smart devices, wearables, and micro-delivery systems for continuous monitoring of women's health parameters and the precise, less invasive administration of therapeutics.
Impactful Policy Frameworks
FDA's Safer Technologies Program (STeP) (2019, updated 2023)
The FDA's STeP aims to facilitate patient access to certain medical devices that demonstrate the potential to significantly improve the safety of currently available treatments or diagnostics.
This program can accelerate the regulatory review and approval process for Femasys's innovative, safety-focused devices, potentially reducing time-to-market for products like FemBloc in the US.
Medical Device User Fee Amendments (MDUFA V) (2022)
MDUFA V reauthorizes the FDA to collect user fees from medical device companies, which are then used to fund the premarket review process for medical devices, with specific performance goals for review times.
MDUFA V sets predictable review timelines and performance goals, which can help Femasys better plan its R&D and market launch strategies for new device submissions to the FDA.
FDA's Framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) (2021)
This framework outlines the FDA's approach to the regulation of AI/ML-based software, focusing on a 'Total Product Lifecycle' approach for adaptive algorithms.
As Femasys explores AI-powered diagnostics, this framework provides crucial guidance for developing and seeking regulatory approval for AI/ML components within its future medical devices, ensuring compliance and innovation.
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