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FDA Clears New AI-Powered Spine MRI Software
Trained on over five million spine MRI scans, the RAI software reportedly facilitates rapid pathology detection and enhanced consistency with disc measurement.
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.
Currently utilized by over 300 radiologists worldwide, RAI, the newly FDA-cleared AI software for spine MRI, reportedly offers automated segmentation and disc measurements that may reduce reading time for radiologists, according to Remedy Logic, the developer of RAI. (Images courtesy of 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.
Mammography News: FDA Grants Expanded 510(k) Clearance for AI-Powered SmartMammo Dx DBT Software
November 29th 2024Originally cleared by the FDA in 2021, the SmartMammo Dx software for digital breast tomosynthesis (DBT) can now be utilized with the Senographe Pristina mammography systems from GE HealthCare.
FDA Grants Expanded 510(k) Clearance for Xenoview 3T MRI Chest Coil in GE HealthCare MRI Platforms
November 21st 2024Utilized in conjunction with hyperpolarized Xenon-129 for the assessment of lung ventilation, the chest coil can now be employed in the Signa Premier and Discovery MR750 3T MRI systems.
