Abstract:
Raman spectroscopy (RS) has emerged as a transformative tool in clinical diagnostics, offering molecular insights into biological samples such as tissues and biofluids. This review explores RS’s clinical applications in oncology, dermatology, and metabolic diseases, with a focus on breast cancer, lung cancer, dermatological conditions, diabetes, and gliomas—diseases with high prevalence and clinical impact. Distinguished by its noninvasive nature, real-time analysis, and cost-effectiveness, RS enables early detection, precise diagnosis, and therapeutic monitoring, improving patient outcomes. Despite its promise, RS faces significant regulatory hurdles, with no FDA-approved medical devices utilizing RS to date. This review critically examines barriers such as reproducibility, signal standardization, and clinical validation, while highlighting technological advancements, including signal amplification, hybrid imaging, and AI-driven analysis, which aim to address these challenges. We predict the first FDA-approved RS device will emerge in the near future, catalyzing broader clinical adoption. By synthesizing key developments in RS applications, regulatory pathways, and technological innovations, this article highlights RS’s transformative potential in modern healthcare. As RS moves closer to clinical integration, it stands poised to address critical gaps in diagnostics and usher in new standards for precision medicine.