M. Keelen
Tessefi Medical Solutions,
United States
Keywords: Smart Catheter, Infection Prevention, Real-Time Monitoring, Closed-Loop
Summary:
Accurate and timely urine output (UO) and urine-quality data are essential for early recognition of acute kidney injury, sepsis, fluid imbalance and more. Yet most hospitals and care facilities still rely on manual assessment using Foley catheters, which are labor-intensive, error-prone, and provide delayed or subjective results. Nursing staff often document urine output inconsistently, sometimes hours late, and color or clarity observations are subjective. These delays and inaccuracies hinder clinical decision-making, compromise patient safety, and contribute to increased healthcare costs. Additionally, Foley catheters carry a high risk of infection, with catheter-associated urinary tract infections (CAUTI) causing hundreds of thousands of infections, thousands of deaths annually, and billions in healthcare expenses worldwide. Tessefi Medical Solutions has developed the Smart Catheter, a patient-centric, patented, closed-loop urine-monitoring system designed to address these limitations. The device integrates multimodal sensors to measure urine volume, color, clarity, and flow in real time. Data are automatically documented every 60 seconds, transmitted securely to electronic health records (EHRs), and clinicians are alerted when patient-specific thresholds are exceeded. Its closed, backflow-resistant design improves patient dignity, reduces infection risk, and ensures reliable, objective data capture. Unlike existing automated urinometers, which are limited to ICU patients and monitor only volume, Smart Catheter provides continuous, individualized monitoring across all hospital units, long-term care, home, and outpatient centers. The platform combines sensor-integrated technology, automated data collection, and closed-loop alerting to enable real-time clinical decision-making. Clinicians can set patient-specific thresholds based on diagnosis, medications, weight, or other factors, enabling precise monitoring and early intervention. By eliminating subjective assessments, reducing manual charting, and automating alerts, Smart Catheter significantly reduces nursing workload. Technology Readiness: Smart Catheter is a fully functional MVP, validated in bench testing, with readiness for clinical validation and regulatory submission. Commercial Potential: Its scalable, patent-protected design positions Tessefi for partnership with hospitals, catheter manufacturers, and EHR vendors, providing clear pathways for market adoption. The potential impact of Smart Catheter is transformative. It addresses a global healthcare need, reducing hospital-acquired infections, supporting better fluid management, and improving patient outcomes. Hospitals could save hundreds of millions annually while enhancing clinician efficiency. Rural and under-resourced healthcare settings could adopt the Smart Cath to extend advanced monitoring to patients far from critical care facilities. Its versatile design also supports applications in military, home health, and global health settings. In summary, Smart Cath redefines urine monitoring by combining real-time, sensor-driven measurement with automated documentation, closed-loop design, individualized alerts, and infection-resistant design. By delivering objective, actionable data while enhancing patient safety and dignity, it represents a superior advance over Foley-based and volume-only technologies, with broad potential impact across healthcare systems worldwide.