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

Abstract

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.

Intellectual Property in Facial Plastic and Reconstructive Surgery: The Importance and Process of Obtaining Intellectual Property Rights

“…The American Academy of Otolaryngology-Head and Neck Surgery (OHNS) Medical Devices and Drugs Committee has reviewed newly approved drugs and devices related to the specialty on a yearly basis since 2019. [15][16][17] Using the FDA's publicly available approval database, the This article is protected by copyright. All rights reserved.…”

“…This was evaluated in 242 patients with cessation in bleeding in 71.1% and 93.1% of patients at 3 and 6 minutes with the Hemostat Bellows as compared to 45.8% and 73.5% at the same time points with use of absorbable gelatin sponge and thrombin (p=0.001). 16,26 This article is protected by copyright. All rights reserved.…”

“…The American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS) Medical Devices and Drugs Committee has reviewed newly approved drugs and devices related to the specialty on a yearly basis since 2019. [15][16][17] Using the FDA's publicly available approval database, the committee identified a total of eight drugs and devices they deemed to be relevant, novel, and impactful to FPRS that received approval between 2019 and 2021 that we will discuss here (►Table 3). Of note, this is not intended to be a comprehensive review of newly developed technologies within FPRS, but rather an overview of IP that has successfully moved through the development and regulatory process to achieve FDA approval and clinical utility.…”

New Medical Device and Therapeutic Approvals in Otolaryngology: State of the Art Review of 2021

“…The Medical Devices and Drugs Committee of the American Academy of Otolaryngology–Head and Neck Surgery annually reviews new FDA approvals with the objective of critical evaluation and to highlight novel drugs or devices that may affect our field. 1 , 2 As compared with 2019 and 2020, the committee has reviewed an increasing number of new FDA-approved devices and drugs. Understanding the innovation behind new developments in medical technology allows otolaryngologists to provide novel, safe, and effective treatment to patients.…”

“…The role of the Food and Drug Administration (FDA) is to ensure safety and efficacy, serving as a gatekeeper for approval of new drugs and devices. The Medical Devices and Drugs Committee of the American Academy of Otolaryngology–Head and Neck Surgery annually reviews new FDA approvals with the objective of critical evaluation and to highlight novel drugs or devices that may affect our field 1,2 . As compared with 2019 and 2020, the committee has reviewed an increasing number of new FDA‐approved devices and drugs.…”