Rapid AI gets FDA nod for Rapid SDH

RapidAI has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) for Rapid SDH, an AI-powered module for detecting suspected hemispheric acute and chronic subdural hematoma.

With the Rapid mobile app, Rapid SDH automatically sends results to the entire trauma team across the hospital system or treatment network.

The company highlighted the following characteristics of Rapid SDH:

  • Features hemispheric subdural hematomas, intracerebral brain hemorrhage, and hyperdensity for faster and complete patient assessment.
  • Positive predictive value of 99% (sensitivity 93%, specificity 99%) for suspected acute and chronic hemispheric subdural hematomas >1 mL.
  • Notifies clinicians in one minute or less.
  • Automatically sends notifications through the Rapid mobile app, PACS, and email.
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