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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 (neurosurg...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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SAGE Publications
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8591653/ https://www.ncbi.nlm.nih.gov/pubmed/34790883 http://dx.doi.org/10.1177/2473974X211057035 |
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author | Brenner, Michael J. Shenson, Jared A. Rose, Austin S. Valdez, Tulio A. Takashima, Masayoshi Ahmed, Omar G. Weissbrod, Philip A. Hong, Robert S. Djalilian, Hamid Wolf, Jeffrey S. Morrison, Robert J. Santa Maria, Peter L. Erbele, Isaac D. |
author_facet | Brenner, Michael J. Shenson, Jared A. Rose, Austin S. Valdez, Tulio A. Takashima, Masayoshi Ahmed, Omar G. Weissbrod, Philip A. Hong, Robert S. Djalilian, Hamid Wolf, Jeffrey S. Morrison, Robert J. Santa Maria, Peter L. Erbele, Isaac D. |
author_sort | Brenner, Michael J. |
collection | PubMed |
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 | Online Article Text |
id | pubmed-8591653 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-85916532021-11-16 New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020 Brenner, Michael J. Shenson, Jared A. Rose, Austin S. Valdez, Tulio A. Takashima, Masayoshi Ahmed, Omar G. Weissbrod, Philip A. Hong, Robert S. Djalilian, Hamid Wolf, Jeffrey S. Morrison, Robert J. Santa Maria, Peter L. Erbele, Isaac D. OTO Open State of the Art Review 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. SAGE Publications 2021-11-10 /pmc/articles/PMC8591653/ /pubmed/34790883 http://dx.doi.org/10.1177/2473974X211057035 Text en © The Authors 2021 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | State of the Art Review Brenner, Michael J. Shenson, Jared A. Rose, Austin S. Valdez, Tulio A. Takashima, Masayoshi Ahmed, Omar G. Weissbrod, Philip A. Hong, Robert S. Djalilian, Hamid Wolf, Jeffrey S. Morrison, Robert J. Santa Maria, Peter L. Erbele, Isaac D. New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review 2020 |
title | 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_short | 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 |
topic | State of the Art Review |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8591653/ https://www.ncbi.nlm.nih.gov/pubmed/34790883 http://dx.doi.org/10.1177/2473974X211057035 |
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