SBIR Phase II: Sensor for Real-Time pH Measurements in Gases

该小型企业创新研究（SBIR）第二阶段项目旨在开发和销售注册商标的Dx-1 pH测量系统。该医疗器械将I期研究中研究的呼吸pH传感器与基于遥测的便携式数据记录仪和数据分析软件集成在一起，以提供医生所需的无创pH诊断工具。该pH传感器主动冷凝传感器表面上的水分膜，从而在其传感电极上创建传导路径。在第二阶段，该公司计划完成所有技术和监管活动，以获得FDA的产品上市许可。该项目的商业应用是在医疗器械领域。拟议的传感器技术将为临床医生提供一种新的工具，以更有效地诊断和治疗呼吸系统疾病，特别是对于那些不能轻易接受替代诊断程序的儿童和婴儿。

This Small Business Innovation Research (SBIR) Phase II project aims to develop and market the trademarked Dx-1 pH Measurement System. This medical device integrates the breath pH sensor studied in the Phase I research with an ambulatory, telemetry based data recorder, and data analysis software to provide a non-invasive pH diagnostic tool required by physicians. This pH sensor actively condenses a moisture film on the sensor surface, creating a conduction path across its sensing electrodes. During Phase II, the company plans to complete all technical and regulatory activities in order to gain FDA clearance for product introduction. The commercial application of this project is in the area of medical devices. The proposed sensor technology will offer a new tool for clinicians to more effectively diagnose and treat respiratory diseases, particularly for children and infants who cannot readily undergo alternative diagnostic procedures.