Etiometry Platform (DAV 5.4 RAE 9.2)
Etiometry Inc.The Etiometry Platform is a software solution designed for use in intensive care settings to help healthcare professionals monitor and assess cardiovascular and respiratory conditions in adult, pediatric, and neonatal patients. It collects real-time physiological and laboratory data remotely from various bedside devices, displays this data, and calculates risk indices like oxygen delivery adequacy and ventilation status. This assists clinicians in timely clinical decision-making without requiring new hardware.
Intended Use
The Data Aggregation & Visualization software module records and displays multiple physiological parameters from adult, pediatric, and neonatal patients; the Risk Analytics Engine calculates indices for inadequate oxygen delivery, ventilation, acidemia, and hyperlactatemia to aid healthcare professionals in patient status assessment.
Technology
Software-only platform that aggregates real-time physiological and laboratory data from multiple bedside medical devices without requiring new hardware; includes a web-based visualization interface and a Risk Analytics Engine that mathematically derives cardiovascular and respiratory risk indices from the aggregated data.
Performance
The device underwent clinical evaluation and software validation following FDA guidance for moderate risk Software as a Medical Device (SAMD). Validation used test and independent datasets from multiple clinical sites with 779 patients. The platform met acceptance criteria for discriminatory power, range utilization, resolution, and robustness without new safety concerns or adverse events.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/24/2024
8 months - 2
FDA Approval
2/12/2025
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.