关键词: innovation medical review new devices

来  源:   DOI:10.1002/oto2.105   PDF(Pubmed)

Abstract:
UNASSIGNED: To review new drugs and devices relevant to otolaryngology approved by the Food and Drug Administration (FDA) in 2022.
UNASSIGNED: Publicly available FDA data on drugs and devices approved in 2022.
UNASSIGNED: A preliminary screen was conducted to identify drugs and devices relevant to otolaryngology. A secondary screen by members of the American Academy of Otolaryngology-Head and Neck Surgery\'s (AAO-HNS) Medical Devices and Drugs Committee differentiated between minor updates and new approvals. The final list of drugs and devices was sent to members of each subspecialty for review and analysis.
UNASSIGNED: A total of 1251 devices and 37 drugs were identified on preliminary screening. Of these, 329 devices and 5 drugs were sent to subspecialists for further review, from which 37 devices and 2 novel drugs were selected for further analysis. The newly approved devices spanned all subspecialties within otolaryngology. Many of the newly approved devices aimed to enhance patient experience, including over-the-counter hearing aids, sleep monitoring devices, and refined CPAP devices. Other advances aimed to improve surgical access, convenience, or comfort in the operating room and clinic.
UNASSIGNED: Many new devices and drugs are approved each year to improve patient care and care delivery. By staying up to date with these advances, otolaryngologists can leverage new innovations to improve the safety and quality of care. Given the recent approval of these devices, further studies are needed to assess long-term impact within the field of otolaryngology.
摘要:
审查食品药品监督管理局(FDA)于2022年批准的与耳鼻喉科相关的新药和设备。
FDA关于2022年批准的药物和设备的公开数据。
进行初步筛查以确定与耳鼻喉科相关的药物和器械。美国耳鼻咽喉头颈外科学会(AAO-HNS)医疗器械和药物委员会成员的二次审查区分了次要更新和新批准。药物和设备的最终清单已发送给每个子专业的成员进行审查和分析。
在初步筛选中总共鉴定出1251种设备和37种药物。其中,329个设备和5种药物被送往专家进一步审查,从中选择了37种设备和2种新药进行进一步分析。新批准的设备涵盖耳鼻喉科的所有亚专科。许多新批准的设备旨在增强患者体验,包括非处方助听器,睡眠监测设备,和精致的CPAP设备。其他旨在改善手术入路的进展,便利性,或舒适的手术室和诊所。
每年都会批准许多新的设备和药物,以改善患者护理和护理服务。通过跟上这些进步,耳鼻喉科医师可以利用新的创新来提高护理的安全性和质量。鉴于这些设备最近的批准,需要进一步的研究来评估耳鼻咽喉科领域的长期影响.
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