Abstract

FROM CLINICS TO COMPLIANCE: THE ROLE OF AI IN ADVANCING MENORRHAGIA TREATMENT AND REGULATORY OVERSIGHT

Acharya Vaishnavi Kamlesh*, Syed Shoaib Ali

Abstract

Menorrhagia, or Heavy Menstrual Bleeding (HMB), is a common gynecological disorder that significantly affects women’s health and quality of life. Conventional diagnostic and treatment approaches often rely on subjective assessment and standardized therapies, leading to delayed diagnosis and inconsistent clinical outcomes. Artificial Intelligence (AI) has emerged as a promising tool in healthcare, enabling improved diagnostic accuracy, predictive analytics, personalized treatment planning, and continuous monitoring through digital platforms. AI-based systems can analyze medical imaging, menstrual health data, and clinical records to support timely and evidence-based clinical decisions. However, the adoption of AI in healthcare introduces important regulatory challenges, including software validation, data privacy, cybersecurity, algorithm transparency, and lifecycle management under Software as a Medical Device (SaMD) frameworks. Regulatory authorities such as FDA, EMA, and CDSCO are developing guidance to ensure safe and effective integration of AI technologies. This review highlights the role of AI in advancing menorrhagia treatment while emphasizing the importance of strong regulatory oversight for ethical and compliant implementation. Conclusion: Artificial Intelligence offers promising advancements in the diagnosis and management of menorrhagia. However, effective regulatory oversight is essential to ensure safety, transparency, and ethical implementation. A balanced integration of innovation and compliance will support the responsible adoption of AI in women’s healthcare.

Keywords: Artificial Intelligence; Menorrhagia; Heavy Menstrual Bleeding; Regulatory Oversight; Software as a Medical Device (SaMD); Digital Health; Healthcare Compliance; Medical Device Regulation.