Workflow
TruDi Navigation System
icon
Search documents
What We’re Reading (Week Ending 15 February 2026) : The Good Investors %
The Good Investors· 2026-02-15 01:00
Group 1: AI in Legal and Medical Fields - AI tools for contract review in regulated environments like clinical trials and financial services must meet high reliability standards, as any missed clause can lead to significant liabilities [3][4] - A comparison between AI systems shows that a purpose-built system (TCN) made 163 substantive changes to a clinical trial agreement, while a general-purpose AI (Claude) made only 11 changes, indicating a significant performance gap [5][8] - The complexity of clinical trial agreements exacerbates the limitations of single-pass AI systems, which struggle to manage multiple provisions and regulatory contexts simultaneously [6][8] Group 2: AI in Medical Devices - The integration of AI into medical devices, such as Johnson & Johnson's TruDi Navigation System, has led to a significant increase in reported malfunctions, with at least 100 adverse events reported since AI implementation [12][13] - Legal actions have been initiated against Acclarent, the distributor of the TruDi system, alleging that the AI component contributed to surgical errors and patient injuries [14][15] - The FDA's regulatory framework for medical devices does not require extensive testing for AI-enabled technologies, raising concerns about their safety and effectiveness [17][18] Group 3: Economic Implications of AI - The rapid development of AI technology is expected to flood the market with new software solutions, potentially leading to a commoditization of software and a decline in the value of companies unable to innovate [19][20] - Historical trends indicate that while earnings may remain stable in the short term, disruptions from AI could take longer to manifest, similar to the decline of newspaper stocks despite initial earnings growth [20] - The relationship between productivity growth driven by AI and median wage growth raises concerns about rising income inequality, which could be addressed through income redistribution policies [30][32]
当AI进入医院,“手术失误、错认器官”等风险也随之而来
Hua Er Jie Jian Wen· 2026-02-11 01:54
医疗器械公司正把AI快速嵌入手术与诊断设备,把"智能化"作为增长卖点的同时,也把新的故障模式与 责任风险带进医院,监管机构收到的疑似伤害与故障申报正在上升。 据路透对安全与法律记录的梳理,以及对医生,护士,科学家和监管人士的采访,美国食品药品监督管 理局(FDA)近年收到的报告中,已出现手术导航误导、心律异常漏报,以及产前超声"错认身体部 位"等问题。 在具体案例上,医疗保健巨头强生旗下医疗器械公司Acclarent于2021年宣布为鼻窦手术导航系统TruDi 引入机器学习算法。 路透称,该设备上市约三年后才加入AI功能。加入AI之前,FDA收到关于设备故障的未证实报告为7 起,另有1起患者受伤报告;加入AI之后,FDA收到的未证实故障与不良事件报告至少达到100起。 路透援引相关报告称,至少10人在2021年末至2025年11月间受伤,多数事件据称与TruDi向术者错误提 示器械在颅内的位置有关。报告描述的后果包括脑脊液从鼻腔渗漏、误穿颅底,以及因大动脉意外受损 而导致的卒中等。 两名卒中患者在得州提起诉讼,指称TruDi系统的AI促成了伤害。其中一份诉状称,该产品在集成AI之 前"可能更安全"。Integ ...