Navigating the Regulatory Pathway for Medical Devices-a Conversation with the FDA, Clinicians, Researchers, and Industry Experts.

Successful translation of new and innovative medical products from concept to clinical use is a complex endeavor that requires understanding and overcoming a variety of challenges. In particular, regulatory pathways and processes are often unfamiliar to academic researchers and start-ups, and even larger companies. Growing evidence suggests that the successful translation of ideas to products requires collaboration and cooperation between clinicians, researchers, industry, and regulators.

The diagnosis of respiratory disease in children using a phone-based cough and symptom analysis algorithm: The smartphone recordings of cough sounds 2 (SMARTCOUGH-C 2) trial design.

The diagnosis of acute respiratory diseases in children can be challenging, and no single objective diagnostic test exists for common pediatric respiratory diseases. Previous research has demonstrated that ResAppDx, a cough sound and symptom-based analysis algorithm, can identify common respiratory diseases at the point of care. We present the study protocol for SMARTCOUGH-C 2, a prospective diagnostic accuracy trial of a cough and symptom-based algorithm in a cohort of children presenting with acute respiratory diseases.

Umbilical Cord Blood Lead Level Disparities between Flint and Detroit.

Objective: The lead-in-water impact of the Flint water crisis on the youngest and most neurodevelopmentally vulnerable population was largely unknown. The objective of this study was to investigate and compare cord blood lead levels (CBLLs) in newborns in Flint, Michigan, after the Flint water crisis, to a group of Detroit newborns.

Study Design: Mothers of 99 Flint newborns were surveyed about potential lead exposures.

Embracing and Advancing the Consumerist Era in Healthcare.

The advent of consumerism-especially increasing demands for data, convenience, and transparency-has emboldened and empowered individuals to expect a consumer-centric experience in every aspect of their lives. The Amazon Prime consumer model has instilled an expectation that every transaction should be friction free, with no exception made for healthcare. Indeed, amid the myriad changes in healthcare in recent years, consumerism is making a pronounced impact on every aspect of healthcare delivery.

Concurrent phone texting alters crossing behavior and induces gait imbalance during obstacle crossing.

Texting during walking has become a very common daily activity and could alter gait performance, especially during locomotion when additional visual attention is demanded, such as obstacle crossing. The purpose of this study was to examine biomechanical changes in obstructed gait characteristics while engaging in a phone texting activity. Gait analyses were performed on ten young healthy adults under the following two tasks: 1) walking and crossing an obstacle set at a 10% of the subject's height and 2) walking and crossing an obstacle while responding to a text message.

Surveying Resident and Faculty Physician Knowledge, Attitudes, and Experiences in Response to Public Lead Contamination.

Environmental health crises can appear anywhere and without warning. After research revealed a significant incidence of elevated pediatric blood lead levels following a water source change, Genesee County declared a public health emergency in Flint, Michigan. Hospital patients and family members began approaching Hurley Medical Center's physicians with questions regarding the health implications of the lead contamination.

Adolescents and young adults with Down syndrome presenting to a medical clinic with depression: co-morbid obstructive sleep apnea.

Adolescents and young adults with Down syndrome (DS) sometimes experience new-onset mood disorder and decline in adaptive skills. The clinical phenomenon is poorly characterized and its pathogenesis is not understood. The possible contribution of obstructive sleep apnea syndrome (OSAS) to this phenomenon has not been studied.

Unleashing the potential: women's development and ways of knowing as a perspective for veterinary medical education.

Women now dominate student enrollment in colleges of veterinary medicine in the USA, as well as in other countries. Projections indicate that this will remain a constant. The implications for teaching, learning, mentoring, leadership, professional development, student and faculty diversity, and curriculum structure are enormous.

"Windshield Tour" - A Journey Towards Cultural Competency.

Purpose: Medical educators are directing greater attention to the promotion of cultural competency when prioritizing educational program goals. An innovative educational approach is described here in a community hospital where nearly one-third of its citizens fall below the poverty level. The intent was to provide a very personal, first-hand learning experience via witnessing living conditions of patients from poverty-stricken neighborhoods.

Expression of Tsga10 sperm tail protein in embryogenesis and neural development: from cilium to cell division.

Tsga10 has been localised in sperm tail as a fibrous sheath protein. In this study, we showed its expression during developmental stages of mouse embryo, in adult mice brain, and in some malignancies. RT-PCR and immunohistochemistry study show that Tsga10 expression starts in 4.

Assessing barriers to the identification of elder abuse and neglect: a communitywide survey of primary care physicians.

Elder abuse and neglect represents an extensive medical and social problem in the United States with an estimated prevalence of 4-10% of older persons. Physicians are mandated to report suspected abuse, but <2% of Adult Protective Service reports are filed by physicians. A knowledge or attitude survey was mailed to all adult primary care physicians in the study community.

Tsga10 encodes a 65-kilodalton protein that is processed to the 27-kilodalton fibrous sheath protein.

We had previously reported the isolation of the testis-specific human gene Tsga10, which is not expressed in testes from two infertile patients. To study its role and function, we cloned the mouse homologue Mtsga10. Mtsga10 localizes to mouse chromosome 1, band B.

Cytogenetic and Y chromosome microdeletion screening of a random group of infertile males.

Objective: To assess whether to perform routine cytogenetic and Y chromosome microdeletion screening on all infertile male patients.

Design: A cytogenetic and Y microdeletion study of a random group of infertile men.

Setting: University department.