Austrian artificial intelligence (AI) startup ImageBiopsy Lab has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its knee osteoarthritis labeling assistant (KOALA) software.
The software assists in the diagnosis of knee osteoarthritis, a disease that affects 70 million people worldwide. The clearance is a big win for Austria, making the startup "one of the first European companies to receive clearance for such complex AI-based software," according to ImageBiopsy Lab CEO Richard Ljuhar.
KOALA will make its U.S. debut at next month's RSNA 2019 conference in Chicago.
![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)
