Artificial intelligence (AI) software developer Aidoc announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI-based brain aneurysm detection algorithm.
The algorithm flags and communicates suspected positive cases of brain aneurysm, while delivering a care coordination workflow that is designed for radiologists, neuroendovascular surgeons, and neurologists who treat multiple patients with different conditions.
The clearance is the ninth that Aidoc has received for algorithms for triage and notification of brain aneurysms.
![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)
