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.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
