FDA Clears Hyperfine AI Software Improving Portable MRI Image Quality

Hyperfine has received FDA clearance for the tenth-generation Optive AI software for its Swoop portable MRI system, marking a significant advance in image quality for ultra-low-field brain MRI imaging. The software enhances each stage of the imaging process, including noise cancellation, image acquisition, reconstruction, and post-processing, resulting in clearer, more anatomically detailed images that some clinical users say approach the quality of conventional 1.5 tesla MRI scanners. This milestone is considered transformative by Hyperfine, as it enables more confident point-of-care diagnoses and is expected to drive broader adoption in hospitals and neurology clinics. The Swoop system remains the first FDA-cleared AI-powered portable MRI for brain imaging across all ages, aiming to increase accessibility where traditional MRI is impractical. Hyperfine plans to roll out the Optive AI software in the third quarter of 2025 and continues to diversify its revenue streams while expanding its market presence. The company has also raised capital to support growth and innovation, with analysts rating Hyperfine as an outperform stock with significant upside potential.