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. A multi-stakeholder group developed this review to enhance regulatory knowledge and thereby improve translational success for medical devices. Communication between and among stakeholders is identified as a critical factor. Current regulatory programs and processes to facilitate communication and translation of innovative devices are described and discussed. Case studies are used to highlight the importance of flexibility when considering evidence requirements. We provide a review of emerging strategies, opportunities, and best practices to increase the regulatory knowledge base and facilitate medical device translation by all stakeholders. Clinicians, regulators, industry, and researchers require regulatory knowledge and collaboration for successful translation of innovative medical devices.

What's Eating You? Culex Mosquitoes and West Nile Virus.

West Nile virus (WNV) commonly presents cutaneously as a maculopapular rash on the trunk and extremities that most often appears around the time of defervescence and may serve as a positive prognostic indicator. Several laboratory tests can aid in diagnosis of WNV, including an IgM enzyme-linked immunosorbent assay (ELISA), but an antibody response may not be detectable for up to 8 days after symptom onset. Taking a comprehensive history in any patient presenting with a generalized maculopapular rash, fever, nonspecific symptoms, or neurologic changes can aid the astute dermatologist in promptly recognizing the possibility of WNV.

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. The objective of the study is to assess the performance characteristics of the ResAppDx algorithm in the diagnosis of common pediatric acute respiratory diseases.

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.EvergreenHealth, an integrated two-hospital healthcare system based in Kirkland, Washington, is addressing the demands of its patient-consumers. We serve nearly 1 million residents at a 318-bed medical center and four medical specialty buildings in Kirkland and a 72-bed hospital in Monroe, Washington. In addition, our 350-member physician multispecialty group encompasses 13 primary care clinics, 5 urgent care clinics, 3 emergency departments, and 26 specialty care practices. EvergreenHealth has been named one of America's 100 Best Hospitals by Healthgrades for three consecutive years (2017-2019), and we earned Healthgrades' Outstanding Patient Experience Award in 2018. In providing an exceptional patient experience, we are seeing that the patient's new role as consumer is an accelerating trend that will continue to drive change and force all health systems to adopt new ways of operating.In fact, I believe that those health systems that embrace the consumerist era of healthcare by investing and innovating in ways that meet patient-consumer needs will remain viable even as sentiments shift, technology evolves, and new threats emerge. In contrast, those that do not heed the consumer's clarion call are in for difficult times.

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. Subjects were ascertained as a convenience sample through our clinic for persons with DS and medical or mental health concerns between 2004 and 2009. When mood symptoms were present an axis I diagnosis was made using DSM-IV-R criteria. Subjects without an axis I diagnosis served as controls. The Reiss scales for children's dual diagnosis and the aberrant behavior checklist (ABC) were completed by caretakers. Twenty-eight cases meeting criteria for major depressive episode (MDE) and nine controls without psychopathology were referred for overnight polysomnography (PSG). Functional decline was reported in 19 (68%) of cases with MDE, but none of the controls. Twenty-four (86%) cases had OSAS compared with only 4 (44%) of controls. Moderate-severe OSAS was present in 15 (54%) of cases compared to only 1 (11%) of controls. Intermittent sleep-associated hypoxia and REM sleep deficits were also more frequent in cases. Across all subjects, prior tonsillectomy was not related to the presence or absence of OSAS. Our findings suggest that OSAS may be a common co-morbidity in adolescents and younger adults with DS and depression. Recognition of this association maybe critical to understanding the pathogenesis and management of mood-related disorders, and functional decline in affected individuals.

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. This article provides the groundwork for examining gender diversity in veterinary medical education. Women's development and ways of knowing are identified as paramount for understanding and benefiting students and faculty in their higher education experiences and in their professional lives. Seminal research focusing on women's development and ways of knowing is introduced, summarized, and contrasted to male-centered models, and implications for teaching practice are considered. Our underlying premise is that research about women's moral and intellectual development is relevant to veterinary education and supports the adoption of student-centered approaches to teaching and learning.

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 4.5-7.5 dpc mouse embryos and continues throughout embryogenesis. Then we showed that the Tsga10 is expressed in adult brain and in the cells with neural crest origin, olfactory epithelium, and human germ cell tumour. It is expressed with two transcripts in sperm and whole embryos but just with the long transcript in brain embryo as a result of its exon 16 splicing. Our finding of the Tsga10 perinuclear localisation and its expression pattern suggests that it may be involved in active cell division, differentiation, and migrating cells. The results of the experiments in this project hypothesize the presence of Tsga10 protein wherever there is a conserved ciliary structure.

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. This region is syntenic with human chromosome 2q11.2, where Tsga10 is located. We demonstrate that Mtsga10 mRNA is expressed in testis, but not in other adult tissues, and in several human fetal tissues and primary tumors. We uncovered that different species use different first exons and, consequently, different promoters. Using several antibodies, we discovered that, in mouse testis, Mtsga10 encodes a 65-kDa spermatid protein that appears to be processed to a 27-kDa protein of the fibrous sheath, a major sperm tail structure, in mature spermatozoa. Mtsga10 protein contains a putative myosin/Ezrin/radixin/moesin (ERM) domain. Transfection of fibroblasts with GFP-Mtsga10 fusion protein results in formation of short, thick filaments and deletion of the myosin/ERM domain abolished filament formation. Our results suggest the possibility that Tsga10 plays a role in the sperm tail fibrous sheath.

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. PATIENT(S): In total, 40 patients had azoospermia (21 nonidiopathic), 27 had severe oligozoospermia/oligoasthenozoospermia (