The decision-support tool assists in the evaluation of previously acquired lumbar spine MRIs.
MSKai, an image identification and post-processing software platform for spine imaging, has received 510(k) clearance from the US Food and Drug Administration (FDA), authorizing its use by physicians and radiologists for lumbar spine MRI analysis.Â
The FDA determined that MSKai is substantially equivalent to legally marketed devices, allowing it to be marketed under the general controls of the Federal Food, Drug, and Cosmetic Act.
“The FDA’s decision confirms that MSKai meets rigorous safety and performance standards as a spine imaging tool,” says Chip Wade, PhD, chief operating officer at MSKai, in a release. “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.”
MSKai is designed to assist medical professionals in the evaluation of previously acquired T2-weighted lumbar spine MRIs. The software enables users to perform anatomy segmentation, labeling, measurement, and export of quantitative and qualitative results into customizable reports.Â
MSKai 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 repeatable 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.
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