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

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rapid ichRapidAI has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the latest release of Rapid ICH—a technology that it describes as “the best-performing” intracranial haemorrhage (ICH) triage and notification product on the market, with a sensitivity of 97% and specificity of 100%.

As per a RapidAI press release, this update further strengthens the “best-in-class” RapidAI haemorrhagic solution, which supports physicians’ ability to address intracranial haemorrhagic management “more accurately and comprehensively than any other solutions on the market”.

While Rapid ICH uses artificial intelligence (AI) to quickly analyse non-contrast computed tomography (CT) scans and notify clinicians of possible haemorrhage, Rapid Hyperdensity then provides physicians with a more refined view by automatically quantifying and characterising tissue to identify the location and volume of hyperdense regions.

Combined, the two products represent the premier haemorrhagic management solution available, the release adds. 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 David Fiorella (Stony Brook Medicine, Stony Brook, USA). “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 haemorrhages. This degree of specificity is a remarkable achievement.”

According to the release, key benefits of Rapid ICH include:

  • Detects suspected ICH as small as 0.4ml in volume—the “only product to do so”
  • Prioritises cases within the radiology worklist
  • Streamlines decision-making by automatically sending notifications of suspected ICH to picture archiving and communication system (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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