Viz.ai announced it has received U.S. Food and Drug Administration (FDA) 501(k) clearance for Viz SDH, which uses artificial intelligence (AI) to detect subdural hemorrhage (SDH).
By detecting SDH automatically, Viz SDH allows physicians to triage patients effectively and deliver care, according to the company. Viz.ai notes that subdural hemorrhage is projected to become the most common neurosurgical diagnosis by 2031, and global clinical trials are investigating new treatments to address this disease.
Viz SDH has the capability to identify acute and chronic subdural bleeds and notify the care team in the event of a necessary immediate intervention, according to Viz.ai.
![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)
