Rapid ICH Receives New FDA Clearance with Highest Sensitivity and Specificity on the Market

New version of ICH reduces notification fatigue with a near perfect false positive rejection rate; and allows medical teams to make faster decisions for improved hemorrhage management

RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, announced it has received FDA 510(k) clearance for the latest release of Rapid ICH — the best performing intracranial hemorrhage (ICH) triage and notification product on the market with a sensitivity of 97% and specificity of 100%.

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“With the sheer number of CT scans performed daily, even relatively low rates of false positive ICH notifications can be disruptive and contribute to notification fatigue”

This new release further strengthens the best-in-class RapidAI hemorrhagic solution — technology that supports physicians’ ability to address intracranial hemorrhagic management more accurately and comprehensively than any other solutions on the market. While Rapid ICH uses artificial intelligence to quickly analyze non-contrast CT (NCCT) scans and notify clinicians of possible hemorrhage, Rapid Hyperdensity then provides physicians with a more refined view by automatically quantifying and characterizing tissue to identify the location and volume of hyperdense regions. Combined, the two products represent the premier hemorrhagic management solution available. For hospitals and mobile stroke units on the front lines of patient assessment, this additional contextual data is critical to helping physicians make more informed triage and transfer decisions — getting patients to the right place for the right care more efficiently.

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“With the sheer number of CT scans performed daily, even relatively low rates of false positive ICH notifications can be disruptive and contribute to notification fatigue,” said Dr. David Fiorella, MD, PhD, Neuroradiologist at Stony Brook Medicine. “The latest release of Rapid ICH essentially eliminates false positives and gives physicians a high degree of confidence to make critical decisions about patients with acute brain hemorrhages. This degree of specificity is a remarkable achievement.”

Key benefits of Rapid ICH include:

• Detects suspected ICH as small as 0.4ml in volume — the only product to do so
• Prioritizes cases within the radiology worklist
• Streamlines decision making by automatically sending notifications of suspected ICH to PACS, email, and the Rapid mobile app
• Drastically reduces the number of false positives, addressing concern of “notification fatigue” for physicians

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