FDA Clears New AI-Powered Spine MRI Software

The Food and Drug Administration (FDA) has granted 510(k) clearance for RAI, an artificial intelligence (AI)-enabled software for spine magnetic resonance imaging (MRI) that may foster improved detection of abnormal findings and degenerative pathology.

Currently utilized by over 300 radiologists worldwide, the RAI software (Remedy Logic) offers automated segmentation and disc measurements that may reduce reading time for radiologists. The software also flags incidental findings, identifies abnormalities, and provides concise summaries for pathology detection, according to Remedy Logic.

The company noted that RAI, which will be showcased at the upcoming Radiological Society of North American (RSNA) 2004 Annual Meeting in Chicago, has been trained with over five million spine MRI scans.

“This achievement (FDA clearance) underscores our commitment to improving efficiency for radiologists for improved safety for patients and completeness and objectivity for referring physicians. who have been left behind by innovation, while addressing the critical issue of spine MRI volumes outpacing available radiologists,” noted Andrej Rusakov, the CEO of Remedy Logic.