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Rapid ICH receives new FDA clearance with highest sensitivity and specificity on the market

Press releases may be edited for formatting or style | November 09, 2022 Alzheimers/Neurology Artificial Intelligence CT X-Ray
SAN MATEO, Calif.— RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, today 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%.

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.

"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."

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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

About RapidAI
RapidAI is the global leader in using AI to combat life-threatening vascular and neurovascular conditions. Leading the next evolution of clinical decision-making and patient workflow, RapidAI is empowering physicians to make faster decisions for better patient outcomes. Based on intelligence gained from over 5 million scans in more than 2,000 hospitals in over 60 countries, the Rapid® platform transforms care coordination, offering care teams a level of patient visibility never before possible.

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