Hyperfine has won FDA clearance for the next version of its Optive AI software, the second software package cleared for its next-generation Swoop portable MRI system since mid-2025.
The company said the update delivers higher image quality across Swoop sequences, a more intuitive scanning experience for operators, and a new isotropic imaging sequence designed for three-dimensional visualization.
Swoop is a low-field, AI-powered portable MRI scanner that does not need the shielding required by conventional high-field systems. That lets it operate in electromagnetically noisy settings such as intensive care units and emergency departments, expanding access to brain imaging outside dedicated radiology suites.
The latest clearance builds on the Optive AI platform that Hyperfine has been refining since the redesigned Swoop launched. The company positions the software as a way to strengthen the clinical utility of portable MRI across care settings, including settings that previously had no access to imaging at all.
Hyperfine, which trades on Nasdaq under the ticker HYPR, said the update also improves ease of use for the nurses and technologists who operate the scanner at the bedside.
