Onc.AI, a developer of AI-driven oncology clinical management software, has received breakthrough device designation from the U.S. Food and Drug Administration (FDA) for the company's Serial CT Response Score (Serial CTRS) AI model.
Serial CTRS is an AI-based prognostic tool that uses deep learning to analyze CT scans and stratify patients into high- or low-mortality risk categories. This aims to help clinicians optimize treatment decisions and perform surveillance of patients with metastatic non-small cell lung cancer.
Onc.AI highlighted Serial CTRS at the Society for Immunotherapy of Cancer (SITC) annual meeting, highlighting a multi-institutional study where the tool improved the prediction of overall survival for patients receiving immunotherapy compared to traditional imaging assessment.
![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)
