New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020

Objectives To evaluate new drugs and devices relevant to otolaryngology–head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. Data Sources Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurger...

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Autores principales:	Michael J. Brenner MD, Jared A. Shenson MD, Austin S. Rose MD, MBA, Tulio A. Valdez MD, MSc, Masayoshi Takashima MD, Omar G. Ahmed MD, Philip A. Weissbrod MD, Robert S. Hong MD, PhD, Hamid Djalilian MD, Jeffrey S. Wolf MD, Robert J. Morrison MD, Peter L. Santa Maria MBBS, PhD, Isaac D. Erbele MD
Formato:	article
Lenguaje:	EN
Publicado:	SAGE Publishing 2021
Materias:	Otorhinolaryngology RF1-547 Surgery RD1-811
Acceso en línea:	https://doaj.org/article/90267ef6f02d4d93a83c75aa4a0c7a8e
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spelling	oai:doaj.org-article:90267ef6f02d4d93a83c75aa4a0c7a8e2021-11-11T22:33:26ZNew Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 20202473-974X10.1177/2473974X211057035https://doaj.org/article/90267ef6f02d4d93a83c75aa4a0c7a8e2021-11-01T00:00:00Zhttps://doi.org/10.1177/2473974X211057035https://doaj.org/toc/2473-974XObjectives To evaluate new drugs and devices relevant to otolaryngology–head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. Data Sources Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees. Review Methods Members of the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA’s device and therapeutic approvals. Two independent reviewers assessed the drug’s or device’s relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature. Conclusions The Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology’s armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology. Implications for Practice New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.Michael J. Brenner MDJared A. Shenson MDAustin S. Rose MD, MBATulio A. Valdez MD, MScMasayoshi Takashima MDOmar G. Ahmed MDPhilip A. Weissbrod MDRobert S. Hong MD, PhDHamid Djalilian MDJeffrey S. Wolf MDRobert J. Morrison MDPeter L. Santa Maria MBBS, PhDIsaac D. Erbele MDSAGE PublishingarticleOtorhinolaryngologyRF1-547SurgeryRD1-811ENOTO Open, Vol 5 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Otorhinolaryngology RF1-547 Surgery RD1-811
spellingShingle	Otorhinolaryngology RF1-547 Surgery RD1-811 Michael J. Brenner MD Jared A. Shenson MD Austin S. Rose MD, MBA Tulio A. Valdez MD, MSc Masayoshi Takashima MD Omar G. Ahmed MD Philip A. Weissbrod MD Robert S. Hong MD, PhD Hamid Djalilian MD Jeffrey S. Wolf MD Robert J. Morrison MD Peter L. Santa Maria MBBS, PhD Isaac D. Erbele MD New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020
description	Objectives To evaluate new drugs and devices relevant to otolaryngology–head and neck surgery that were approved by the US Food and Drug Administration (FDA) in 2020. Data Sources Publicly available device and therapeutic approvals from ENT (ear, nose, and throat), anesthesia, neurology (neurosurgery), and plastic and general surgery FDA committees. Review Methods Members of the American Academy of Otolaryngology–Head and Neck Surgery’s Medical Devices and Drugs Committee reviewed new therapeutics and medical devices from a query of the FDA’s device and therapeutic approvals. Two independent reviewers assessed the drug’s or device’s relevance to otolaryngology, classified to subspecialty field, with a critical review of available scientific literature. Conclusions The Medical Devices and Drugs Committee reviewed 53 new therapeutics and 1094 devices (89 ENT, 140 anesthesia, 511 plastic and general surgery, and 354 neurology) approved in 2020. Ten drugs and 17 devices were considered relevant to the otolaryngology community. Rhinology saw significant improvements around image guidance systems; indications for cochlear implantation expanded; several new monoclonal therapeutics were added to head and neck oncology’s armamentarium; and several new approvals appeared for facial plastics surgery, pediatric otolaryngology, and comprehensive otolaryngology. Implications for Practice New technologies and pharmaceuticals offer the promise of improving how we care for otolaryngology patients. However, judicious introduction of innovations into practice requires a nuanced understanding of safety, advantages, and limitations. Working knowledge of new drugs and medical devices approved for the market helps clinicians tailor patient care accordingly.
format	article
author	Michael J. Brenner MD Jared A. Shenson MD Austin S. Rose MD, MBA Tulio A. Valdez MD, MSc Masayoshi Takashima MD Omar G. Ahmed MD Philip A. Weissbrod MD Robert S. Hong MD, PhD Hamid Djalilian MD Jeffrey S. Wolf MD Robert J. Morrison MD Peter L. Santa Maria MBBS, PhD Isaac D. Erbele MD
author_facet	Michael J. Brenner MD Jared A. Shenson MD Austin S. Rose MD, MBA Tulio A. Valdez MD, MSc Masayoshi Takashima MD Omar G. Ahmed MD Philip A. Weissbrod MD Robert S. Hong MD, PhD Hamid Djalilian MD Jeffrey S. Wolf MD Robert J. Morrison MD Peter L. Santa Maria MBBS, PhD Isaac D. Erbele MD
author_sort	Michael J. Brenner MD
title	New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020
title_short	New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020
title_full	New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020
title_fullStr	New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020
title_full_unstemmed	New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020
title_sort	new medical device and therapeutic approvals in otolaryngology: state of the art review 2020
publisher	SAGE Publishing
publishDate	2021
url	https://doaj.org/article/90267ef6f02d4d93a83c75aa4a0c7a8e
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New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020

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