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.
