2013年至2023年间胃肠病学医学技术的当代景观
Megan M Hennessey1, Shan Xue1, Rebecca Z Strigenz1
1Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
The American journal of gastroenterology
|February 14, 2025
概括
新的胃肠道医学技术,主要是通过510 (k) 途径获得FDA批准,往往缺乏可靠的临床数据. 提出了一个框架,以平衡有效性,安全性和成本效益,以便更好地采用技术.
科学领域:
- 胃肠病学 胃肠病学
- 医疗技术 医疗技术 医学技术
- 医疗信息学 医疗信息学
背景情况:
- 胃肠病学的医疗技术正在迅速发展,包括设备,诊断,数字健康和人工智能.
- 美国食品和药物管理局 (FDA) 审查这些创新,以支持临床整合.
研究的目的:
- 在胃肠病学中对FDA审查的医疗技术进行叙事审查.
- 评估支持临床采用这些新技术的证据基础.
主要方法:
- 在2013年至2023年期间,对FDA批准或批准的胃肠道器械进行叙述性审查.
- 技术途径 (510(k) 与 de novo 的分析,临床试验数据和成本效益.
主要成果:
- 713种新的胃肠道器械得到了FDA的批准/批准,62%用于一般内镜,24.1%用于高级内镜.
- 99%使用了510 (k) 途径;临床试验 (19 个设备) 规模很小,专注于技术上的成功而不是患者的结果.
- 12 种设备 (63.2%) 有有利的成本效益数据.
结论:
- 大多数新的GI技术通过510 (((k) 途径进入市场,临床证据有限.
- 建议制定一个平衡有效性,安全性和成本效益的框架,以指导采用新高风险技术.
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