FDA Clears AI Software for Lumbar Spine MRI Analysis

The Food and Drug Administration (FDA) has granted 510(k) clearance for MSKai software, which offers a variety of adjunctive artificial intelligence (AI) tools for evaluating lumbar spine magnetic resonance imaging (MRI).

Through assessment of T2-weighted MRI scans of the lumbar spine, the MSKai software provides pathology detection, anatomical segmentation, labeling, and measurements within seconds, according to MSKai, the developer of the software.

The company maintained that the MSKai software can facilitate pre-surgical authorizations as well as monitoring of post-intervention treatments.

"The FDA's decision confirms that MSKai meets rigorous safety and performance standards as a spine imaging tool," said Chip Wade, Ph.D., chief operating officer at MSKai. "We're proud to deliver a product that gives healthcare professionals enhanced capabilities in lumbar spine analysis while reinforcing the central role of expert clinical judgement."