MSKai has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), authorizing the technology's use by physicians and radiologists to analyze lumbar spine MR images.
MSKai assists qualified medical professionals in the evaluation of previously acquired T2-weighted lumbar spine MRIs. The software allows users to perform anatomy segmentation, labeling, measurement, and export of quantitative and qualitative results into customizable reports, thus supporting greater efficiency and consistency in clinical imaging workflows, the company said.
MSKai did note that the technology is not a diagnostic device and does not provide or recommend any medical diagnosis or treatment. Instead, it serves as a decision-support tool that offers insights for users trained in medical imaging. Users are responsible for confirming preferences, verifying automated measurements, and finalizing reports in accordance with clinical best practices, it 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)
