新加坡批准AI工具, 使用生命迹象预测病人恶化。 Singapore approves AI tool that predicts patient deterioration using vital signs.

位于新加坡的AI健康技术初创公司Respiree已获得新加坡卫生科学局的批准, 作为B类医疗设备, 获得了1BioTMAI-Acute软件的批准. Respiree, a Singapore-based AI health-tech startup, has received approval from Singapore’s Health Sciences Authority for its 1Bio™AI-Acute software as a Class B medical device. AI工具分析生命迹象——脉搏率、呼吸率、氧饱和度和血压——以预测急性病人恶化,目的是提高检测准确度和减少虚假警报。 The AI tool analyzes vital signs—pulse rate, respiratory rate, oxygen saturation, and blood pressure—to predict acute patient deterioration, aiming to improve detection accuracy and reduce false alarms. 批准是在对Mayo诊所记录进行同行审查研究之后批准的,并清除了软件及其RS001可磨损装置。 The approval follows a peer-reviewed study in the Mayo Clinic Proceedings and clears both the software and its RS001 wearable device. 该公司计划在欧盟、澳大利亚和美国现有许可的基础上,在其他亚太、安非他明区和美国市场寻求监管批准。 The company plans to seek regulatory approvals in other Asia-Pacific, ANZ, and U.S. markets, building on existing clearances in the EU, Australia, and the U.S.