Image-based diagnostics remain foundational to women’s health point-of-care testing, yet traditional microscopy is subjective and frequently inaccurate, contributing to high rates of inappropriate treatment. As care increasingly shifts beyond specialty practices into decentralized settings, improving diagnostic accuracy at the moment of care is imperative. This presentation examines how AI-assisted digital microscopy can responsibly augment clinician judgment, supported by real-world deployment insights and a practical regulatory pathway from LDT toward CLIA-waiver.

With increases in the number of minimally invasive procedures, the need for rapid assessment of fine needle biopsy smears and imprint cytology of core needle biopsy at the site of the procedure are becoming an integral component of patient care. In addition, the growing numbers of off-site imaging facilities require access to distant interpretation of test results. With advances in digital imaging, it is now possible to provide rapid on-site evaluation (ROSE). This practice will provide a possibility for health care providers to learn about the possible diagnosis on each patient and to also limit the number of needle biopsies.

The future of pathology and laboratory medicine increasingly depends on diagnostic power projection—the ability to extend expertise, analytics, and decision support beyond centralized laboratories. The field is undergoing a fundamental transformation driven by digital workflows and artificial intelligence (AI). This session explores how AI-enabled image analysis, integrated data platforms, and automation are reshaping diagnostic practice, improving efficiency, and expanding access to specialized expertise. Emphasis is placed on the shift toward distributed diagnostics, including digital pathology and point-of-care testing, alongside key technical, regulatory, and operational considerations for safe, scalable, and clinically meaningful adoption across health systems.

Hypertension diagnosis and treatment costs more than than $30B annually, involves 1/3 of the US population, and is only controlled in 25% of patients. We have re-evaluated the diagnostic criteria by deconvoluting the underlying circadian pattern to personalize the condition and separate out cardiac vs vascular causes separately to identify the correct treatment for an individual. This establishes a new paradigm for diagnosis and treatment of hypertension.