The U.S. Food and Drug Administration has cleared a tenth-generation software for the Swoop Portable Magnetic Resonance Imaging system.

The new software, Optive AI, introduces image quality enhancement for the company’s AI-powered, ultra-low-field MRI platform for the brain. The Swoop system provides brain imaging in patients of all ages and is designed for clinical environments where conventional MRI may not be feasible. When interpreted by a trained physician, the resulting images support diagnostic decision-making. 

The software incorporates advanced algorithms that optimize multiple phases of the imaging pipeline, including noise cancellation, acquisition, reconstruction, and postprocessing. According to the company, these improvements result in enhanced image clarity, uniformity, and anatomical detail across all sequences.

"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," said Rafael O’Halloran, Vice President of Technology at Hyperfine, the manufacturer.

Preliminary deployment of the software at selected clinical sites earlier in the year was met with positive feedback, with several users reporting image quality that approaches that of conventional 1.5-tesla MRI systems. These early impressions suggest potential for improved diagnostic confidence in point-of-care settings.

The Optive AI rollout is scheduled to begin in the third quarter of 2025.

Source: Hyperfine