Hille J Torenvlied, Rob C M Pelger, Loes I Segerink, Jack J H Beck
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引用次数: 0
Abstract
Erectile dysfunction (ED) diagnostics are in need of innovation, as traditional tools like the RigiScan face usability challenges and limited clinical adoption. Although several novel sensor systems have been proposed, none have undergone comprehensive clinical validation. This opinion article outlines a structured, three-phase validation framework comprising component validation, system feasibility testing, and clinical validation, aligned with European MDR requirements. Special attention is given to key aspects such as diagnostic accuracy, sleep-stage monitoring, and patient experience. By providing a clear validation pathway, this opinion article aims to support researchers in the development of reliable, patient-friendly, and regulatory-ready tools for non-invasive ED diagnosis.
期刊介绍：
Andrology is the study of the male reproductive system and other male gender related health issues. Andrology deals with basic and clinical aspects of the male reproductive system (gonads, endocrine and accessory organs) in all species, including the diagnosis and treatment of medical problems associated with sexual development, infertility, sexual dysfunction, sex hormone action and other urological problems. In medicine, Andrology as a specialty is a recent development, as it had previously been considered a subspecialty of urology or endocrinology
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