Ultrasound Workspace (UWS 6.0)
Philips Ultrasound LLCUltrasound Workspace (UWS 6.0) is a clinical software package from Philips designed for analyzing and quantifying ultrasound images of cardiovascular, fetal, and abdominal structures. Using AI and machine learning, it supports physicians in diagnosing conditions by automating the measurement of heart functions, valve anatomy, and blood flow dynamics. This helps improve efficiency and accuracy in interpreting ultrasound exams, particularly in adult cardiac applications.
Intended Use
Ultrasound Workspace is a clinical software package designed for review, quantification and reporting of cardiovascular, fetal, and abdominal structures and function of patients with suspected disease to support the physician in the diagnosis.
Technology
The software integrates semi-automated machine learning algorithms for segmental wall motion scoring of left ventricle (SWM), 3D model-based segmentation for tricuspid and mitral valves (3D Auto TV and 3D Auto CFQ), and a fluid dynamic model for mitral regurgitation quantification based on 3D color flow ultrasound data. The system is compatible with VeriSight ICE / Pro ICE probes for intracardiac ultrasound imaging.
Performance
Performance validation includes retrospective studies and user evaluations for SWM scoring showing strong correlation with predicate LVivo SWM software; agreement studies for 3D Auto TV valve measurements compared to manual ground truth yielding high accuracy; and comparative studies of 3D Auto CFQ mitral regurgitation volume measurements against cardiac MRI and PISA methodology with acceptance criteria met. Usability testing showed a 97.7% success rate for critical tasks.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/10/2024
8 months - 2
FDA Approval
2/10/2025
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