Subtle Medical has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for SubtleHD(CT), an AI-powered image enhancement software for CT imaging.
The software reduces noise and improves low-contrast detectability across CT scanner generations, according to the company. It is designed to integrate into existing workflows without requiring hardware changes, Subtle Medical said.
SubtleHD(CT) is the company's first CT product and its eleventh FDA-cleared product overall, expanding a portfolio that already includes AI image enhancement software for MRI and PET across more than 1,300 scanners worldwide, according to the company.
![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)
