Bladder AI is a software designed to assist healthcare providers in measuring bladder volume from ultrasound images using machine learning. It supports image-based assessment, landmark placement, and report generation for patients aged 2 years and older, improving workflow efficiency and accuracy in bladder volume quantification.
Intended Use
Bladder AI uses machine-learning techniques to aid in the quantification of bladder volume from ultrasound images. The device is intended to be used on images of patients aged two years or older.
Technology
Bladder AI is standalone software as a medical device (SaMD) that imports DICOM ultrasound images, uses ML-based semi-automatic landmark placements, and image segmentation for border detection to measure bladder dimensions and volume, and enables report generation. It runs on a web browser (Google Chrome).
Performance
Performance was evaluated on 122 subjects with diverse demographics and ultrasound devices, showing high accuracy and reliability compared to expert clinicians. The ICC for bladder volume measurements was 0.97-0.98 with mean volume differences within clinically acceptable limits. Evaluation included testing per FDA software guidelines and IEC standards.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/24/2023
3 months - 2
FDA Approval
6/22/2023
Other devices from Exo Inc
- Strain AI (SAI001)2024 • 510K
- AI Platform (AIP001)2023 • 510K
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.