FDA Clears MRI DWI Sequence for Enhanced Stroke Detection

The Food and Drug Administration (FDA) has granted 510(k) clearance for a multi-direction diffusion-weighted imaging (DWI) sequence that may bolster image quality in stroke detection with the portable brain magnetic resonance imaging (MRI) Swoop system.

In order to facilitate more consistent image quality, Hyperfine, the manufacturer of the Swoop system, said the DWI sequence averages signals obtained from multiple directions. By employing a multi-directional acquisition approach akin to the methodology for high-field MRI, the new DWI sequence enhances sensitivity for detecting small strokes and improves specificity for infarcts, according to Hyperfine.

The company maintained that the multi-directional DWI sequence as well as the existing single-direction DWI sequence — which accommodates the rapid imaging requirements for stroke treatment protocols — are both available for all Swoop system models.

"From a clinical perspective, adding this multi-direction DWI sequence is a game-changer for stroke imaging with portable MRI," said Edmond Knopp, the chief medical officer for Hyperfine. “The ability to more confidently detect smaller stroke lesions is particularly valuable for critical care settings, including cardiac ICUs, post-procedure follow-up imaging, and baseline assessments for emergency department triage and discharge decisions. Meanwhile, our single-direction DWI is faster and aligns well with stroke protocols, which is a real advantage in ultra-urgent situations, such as when clinicians need to determine whether to administer thrombolytic therapy.”