RapidAI’s Rapid SDH Module Cleared by FDA for Detection of Hemispheric Subdural Hematomas

November 9, 2023—RapidAI, a developer of artificial intelligence (AI) and technology workflow solutions in the treatment of neurovascular, trauma, cardiac, and vascular conditions, announced that the company’s AI-powered module for the detection and notification of suspected hemispheric acute and chronic subdural hematoma (SDH)—Rapid SDH—has received FDA clearance.

In November 2022, the company announced that its module for intracranial hemorrhage (ICH) received FDA clearance. In July 2022, FDA clearance was announced for the company’s Rapid Hyperdensity module for assessing the volume of hyperdense tissue in the brain in traumatic brain injury and brain hemorrhages.

Rapid SDH, Rapid ICH, and Rapid Hyperdensity comprise RapidAI’s hemorrhagic and trauma care AI solution for assessing patients, streamlining decision-making, and expediting patient care.

According to the company, Rapid SDH leverages AI and the intelligence gained from analyzing hundreds of patient scans to help neurocritical care teams identify suspected hemispheric subdural hemorrhage faster and with a higher degree of accuracy than traditional methods.

With the advanced Rapid mobile app, Rapid SDH automatically sends results to the entire trauma team across the hospital system or treatment network, enabling clinicians to make more timely and informed transfer and treatment decisions for patients with traumatic brain injury or hemorrhagic stroke.

RapidAI outlined key features of Rapid SDH and the trauma care solution as follows:

• It is a hemorrhagic and trauma package with hemispheric SDH, ICH, and Hyperdensity modules, providing faster and complete patient assessment
• Rapid SDH offers positive predictive value of 99% (sensitivity 93%, specificity 99%) for suspected acute and chronic hemispheric subdural hematomas > 1 mL
• Provides faster results by notifying clinicians in ≤ 1 minute
• Automatically sends notifications through the Rapid mobile app, PACS, and email, facilitating treatment and transfer decisions of patients with subdural hematomas