FDA Clears Updated DWI Software for Portable MRI Neuroimaging Device

The Food and Drug Administration (FDA) has granted 510(k) clearance to new software for the Swoop® Portable MR Imaging device that may significantly enhance the quality of diffusion-weighted magnetic resonance imaging (MRI) for neurocritical patients.

The new software offers a 42 percent increase in the signal-to-noise ratio for diffusion-weighted imaging (DWI) sequences, according to Hyperfine, the manufacturer of the device. The company noted other benefits of the software include additional compensation for subtle patient movements and more uniform imaging for DWI sequences.

Emphasizing the key role DWI imaging plays in facilitating prompt diagnosis of an array of neurological conditions as well as the monitoring of stroke progression, Hyperfine said the updated software will provide a significant advance in care for high-risk populations.

“With this latest software, Swoop system images provide increasingly valuable diagnostic images that can aid clinicians in caring for neurocritical patients,” noted Edward Knopp, M.D., the senior medical director with Hyperfine.

Hyperfine received an FDA 510(k) clearance earlier this month for the device’s updated brain imaging software. The company said the updated DWI software will be available in March 2023.

(Editor’s note: For related content, see “Emerging Deep Learning System May Enhance MRI Assessment of Intracranial Tumors” and “FDA Clears AI-Enabled Software for Streamlining Brain MRI Assessment and Reporting.”)