【英文原文摘要】
The Food and Drug Administration (FDA) has now authorised more than 1,500 AI enabled devices, MedTech Dive reported. An editor's note from the publication describes how the technology is spreading through the sector. Many of the FDA AI enabled medical devices won authorisation in just the past several years.
Artificial intelligence is taking off across the medical device industry. It has changed what counts as a medical device, and it is carrying medtech into new areas. Developers now use AI to detect health conditions such as sepsis, while other tools identify heart health problems.
In June 2025, the FDA authorised the first AI tool to predict a patient's five year breast cancer risk from a routine mammogram. Clairity made the tool. AI that detects breast cancer has been in use for decades, but those tools look for disease that may already be present; the Clairity tool is the first to forecast future risk instead.
Use of the technology keeps moving quickly as it becomes more common. Foundation models are one example, drawing device makers such as GE HealthCare and Aidoc, as well as technology groups such as Nvidia and Amazon Web Services. Medtech companies have also begun to look at generative AI as a way to build new products and technologies, but the FDA has not yet made clear its approach to regulating generative AI.
The growing role of AI in medtech raises several questions: companies and regulators must determine how to deploy tools effectively and test them for safety and bias, and they must also settle how rules should apply to the technology.
【中文翻译】
据MedTech Dive报道，美国食品药品监督管理局（FDA）目前已授权超过1500项含人工智能（AI）功能的医疗器械。该媒体的编者按指出，这项技术正加速渗透整个行业，其中大量FDA AI医疗器械是在过去数年内获得授权的。
人工智能正在医疗器械行业全面起飞。它不仅改变了“什么算作医疗器械”的定义，也正把医疗科技带入新的领域。开发者如今利用AI来识别脓毒症（sepsis）等健康状况，其他工具则用于识别心脏健康问题。
2025年6月，FDA授权了首个可通过常规乳腺X线摄影（mammogram）预测患者五年乳腺癌风险的AI工具，该工具由Clairity公司开发。用于检出乳腺癌的AI已应用数十年，但这类工具寻找的是可能已经存在的病灶；Clairity的工具则是首个用于预测未来风险的产品。
随着技术愈发普及，其应用步伐持续加快。基础模型（Foundation models）即为其中一例，吸引了GE HealthCare、Aidoc等器械制造商，以及英伟达（Nvidia）、亚马逊云科技（AWS）等技术企业参与。医疗科技公司也已开始把生成式AI视为构建新产品和新技术的手段，但FDA尚未明确其对生成式AI的监管思路。
AI在医疗科技中日益重要的角色带来若干问题：企业与监管机构必须确定如何有效部署这些工具，并对其开展安全性与偏倚（bias）测试；同时还需明确相关规则应如何适用于这项技术。MedTech Dive将该编者按作为其AI如何改变医疗科技行业系列报道的开篇。
