Rapid LVO
iSchemaView Inc.Rapid LVO is a software device designed to analyze CT angiography images of the head to help healthcare providers identify suspected large vessel occlusions quickly. By flagging possible cases of ICA or MCA-M1 occlusion and providing notifications with preview images, it supports faster triage and prioritization of medical images, aiding timely clinical decision-making in stroke care.
Intended Use
Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. It assists hospital networks and trained radiologists in workflow triage by flagging suspected positive ICA or MCA-M1 Large Vessel Occlusion findings in head CTA images.
Technology
Rapid LVO uses a traditional software algorithm to analyze CT angiography images and highlight suspicious LVO cases, operating on standard PC workstations or virtual platforms. It functions in parallel with the standard of care, delivering notifications with compressed preview images without altering original medical images.
Performance
Performance was validated extensively with clinical data from 217 CTA scans across multiple sites, using expert neuroradiologist consensus as ground truth. Results showed high sensitivity (96%) and specificity (98%) for LVO detection. Time-to-notification averaged 3.18 minutes, meeting the predefined goal.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/2/2022
29 days - 2
FDA Approval
5/31/2022
Other devices from iSchemaView Inc.
- Rapid ASPECTS (v3)2024 • 510K
- Rapid (6.0)2024 • 510K
- Rapid SDH2023 • 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.