Cargando…

United States Food and Drug Administration’s 510(k) Pathway: Drawing Implications from the Approvals of Brachytherapy Devices

Introduction Innovations in cancer treatment coupled with an increasing number of cancer patients have led to the growth of brachytherapy devices. The objective of this study is to characterize the development and safety of brachytherapy devices marketed in the United States (US) over the last 15 ye...

Descripción completa

Detalles Bibliográficos
Autores principales:	Wang, Sophie, Manudhane, Albert, Ezaldein, Harib H, Scott, Jeffrey F
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Cureus 2019
Materias:	Dermatology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6510570/ https://www.ncbi.nlm.nih.gov/pubmed/31123652 http://dx.doi.org/10.7759/cureus.4230

Ejemplares similares

YouTube as a Source of Hidradenitis Suppurativa Patient Education: A Social Media Content Analysis
por: Raime, Daniela P, et al.
Publicado: (2023)

Utilization and Cost of Inpatient Dermatologic Procedures: A Cross-sectional Analysis
por: Schrom, Kory P, et al.
Publicado: (2019)

Acne and craniofacial defects
por: Langenderfer, Lauren, et al.
Publicado: (2019)

Hyperpigmented patch of the left hemithorax
por: Levin, Adam, et al.
Publicado: (2019)

An eruption of erythematous plaques in a patient receiving chemotherapy
por: Scheufele, Christian, et al.
Publicado: (2019)

Pustular palm eruption with axial skeleton involvement
por: Mehrmal, Sino, et al.
Publicado: (2019)

Risk of Recall Among Medical Devices Undergoing US Food and Drug Administration 510(k) Clearance and Premarket Approval, 2008-2017
por: Dubin, Jonathan R., et al.
Publicado: (2021)

Premarket Approval Through the 510(k) Process: Lessons from the Translation Process of Magnetic Resonance Elastography
por: Aponte Ortiz, Jaime A., et al.
Publicado: (2018)

Dosimetric Superiority of High-Dose-Rate (HDR) Brachytherapy Using a Surface Mold Applicator for Primary Cutaneous Angiosarcoma of the Scalp
por: Takase, Kei, et al.
Publicado: (2022)

Cutaneous Manifestations of Nutritional Deficiencies in the Context of Food Deserts of United States
por: Canakis, Justin P, et al.
Publicado: (2022)

Eruptive melanocytic nevi in a patient with Parkinson disease treated by carbidopa-levodopa
por: Haraszti, Samantha, et al.
Publicado: (2018)

FDA Approved Biologics: Can Etanercept and Ustekinumab be Considered a First-Line Systemic Therapy for Pediatric/Adolescents in Moderate to Severe Psoriasis? A Systematic Review
por: Aslam, Nida, et al.
Publicado: (2020)

Toward Soluble 5,10-Diheterotruxenes: Synthesis and Reactivity of 5,10-Dioxatruxenes, 5,10-Dithiatruxenes, and 5,10-Diazatruxenes
por: Górski, Krzysztof, et al.
Publicado: (2020)

Long Term Administration of Nivolumab for Metastatic Melanoma: A Case Report
por: Oprea, Adela-Raluca, et al.
Publicado: (2022)

Well-circumscribed retiform ulcerations
por: Shah, Nehal, et al.
Publicado: (2019)

Morbilliform Eruption After Administration of Second Dose of Oxford/AstraZeneca Vaccine
por: Alhammad, Norah S, et al.
Publicado: (2022)

Abstract QS26: A Prospective Pilot Study of Robotic-Assisted Harvest of the Latissmus Dorsi Muscle for FDA 510(K) Approval
por: Shuck, John, et al.
Publicado: (2018)

Relationship Between Atopic Dermatitis and Food Allergy in Children
por: Mehta, Yash, et al.
Publicado: (2022)

Multiple self-healing palmoplantar carcinoma: An aberrance of the inflammasome
por: Scheufele, Christian, et al.
Publicado: (2019)

Adrenal Insufficiency Following Prolonged Administration of Ultra-High Topical Steroid: A Case of Refractory Dermatitis
por: Kijima, Tsunetaka, et al.
Publicado: (2023)

Stevens-Johnson Syndrome in a Patient With Recent SARS-CoV-2 Infection and Ciprofloxacin Administration
por: Skafida, Evgenia, et al.
Publicado: (2023)

Food Allergens and Essential Oils in Moisturizers Marketed for Children in Japan
por: Horimukai, Kenta, et al.
Publicado: (2023)

Psoriasis and Metabolic Syndrome: Comorbidities and Environmental and Therapeutic Implications
por: Peralta, Cesar, et al.
Publicado: (2019)

Acrodermatitis Enteropathica: A Rare Case With Lifelong Implications
por: Alwadany, Muhannad M, et al.
Publicado: (2023)

Chronic Urticaria Suspected to be Caused by a 13.5 mg Levonorgestrel Intrauterine Device (Skyla®)
por: Ganguli, Malika P, et al.
Publicado: (2023)

Cutaneous Leukocytoclastic Vasculitis Following Influenza Vaccination in Older Adults: Report of Bullous Purpura in an Octogenarian after Influenza Vaccine Administration
por: Chen, Stella X, et al.
Publicado: (2018)

Lichen Planus Eruption Following Oxford-AstraZeneca COVID-19 Vaccine Administration: A Case Report and Review of Literature
por: Alrawashdeh, Hamzeh M, et al.
Publicado: (2022)

Investigating Skin Rashes Associated With Pantoprazole Medication: Causes and Clinical Implications
por: Krishnan, Suhasini, et al.
Publicado: (2023)

Hedgehog Pathway Inhibitors: Clinical Implications and Resistance in the Treatment of Basal Cell Carcinoma
por: Habashy, Suzanne, et al.
Publicado: (2021)

Five-Year Remission of Hidradenitis Suppurativa Following the Removal of a Levonorgestrel Intrauterine Device and Disease Overview for Obstetrics and Gynecology Providers
por: Hengy, Meredith H, et al.
Publicado: (2022)

Dermatofibrosarcoma Protuberans Presenting in a Patient With Neurofibromatosis Type 1: Potential Implications on Treatment
por: Eubanks, Bianca N, et al.
Publicado: (2021)

Electrosclerotherapy for capillary malformations: study protocol for a randomised within-patient controlled pilot trial
por: Horbach, Sophie E R, et al.
Publicado: (2017)

The 510(k) Third Party Review Program: Promise and Potential
por: Miller, Brian J., et al.
Publicado: (2023)

Identification of predicate creep under the 510(k) process: A case study of a robotic surgical device
por: Lefkovich, Charlotte, et al.
Publicado: (2023)

Atypical Intraepidermal Melanocytic Proliferation Masked by a Tattoo: Implications for Tattoo Artists and Public Health Campaigns
por: Navrazhina, Kristina, et al.
Publicado: (2018)

The Chip Score: A Method to Determine Risk of Surgical Intervention for Hemangioma Patients
por: Wee, Corinne, et al.
Publicado: (2019)

Relative Importance of Mode of Administration in Treatment Preferences among Plaque Psoriasis Patients in the United States
por: Feldman, Steven R., et al.
Publicado: (2016)

Parents and GPs’ understandings and beliefs about food allergy testing in children with eczema: qualitative interview study within the Trial of Eczema allergy Screening Tests (TEST) feasibility trial
por: Clement, Clare, et al.
Publicado: (2020)

Understanding the influence of patient demographics on disease severity, treatment strategy, and survival outcomes in merkel cell carcinoma: a surveillance, epidemiology, and end-results study
por: Ezaldein, Harib H., et al.
Publicado: (2017)

An Urban Case of Chromoblastomycosis in the United States
por: Canela, Victor A, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_mus4n3vdlq8i7jnncvv51agdui