FDA Clears Next-Generation AI Software for Portable Brain MRI

The Food and Drug Administration (FDA) has granted 510(k) clearance for the Optive AI software, which may significantly elevate the quality of ultra-low-field brain MRI scans.

The tenth software release for the Swoop portable MRI system, the Optive AI software utilizes advanced algorithms to bolster noise cancellation, image reconstruction and post-processing, according to Hyperfine, the developer of the Swoop MRI platform.

Hyperfine noted that use of the Optive AI software allows for sharper clarity and anatomical detail across all sequences obtained with ultra-low-field brain MRI.

“The advanced AI algorithms integrated into our new software platform dramatically elevate image quality at ultra-low field strength, enabling more confident diagnoses at the point of care,” noted Rafael O’Halloran, the vice president of technology at Hyperfine.

The company said the Optive AI software will be available in the third quarter of 2025.