Samsung NeuroLogica has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Auto Lung Nodule Detection (ALND) tool, an artificial intelligence (AI)-assisted detection program for locating pulmonary nodules.
The tool is specifically designed to aid physicians in reviewing posteroanterior chest radiographs in adults for nodules 10 mm to 30 mm in size. The program is part of S-Station, the operating software installed on Samsung's digital x-ray imaging systems and includes an autorun option that automatically performs nodule detection after chest x-ray imaging.
Chest radiograph without Auto Lung Nodule Detection (ALND) and chest radiograph with lung nodule marked. Image courtesy of Neuologica.In international clinical trials, ALND achieved a sensitivity of at least 80% identifying lung cancer in 600 chest x-rays, the company said.
![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)
