Investing.com -- Hyperfine, Inc. (NASDAQ:HYPR) stock climbed 8.4% in Monday’s premarket trading after the company announced FDA clearance for a new multi-direction diffusion-weighted imaging (DWI) software sequence for its portable MRI system.
The new technology delivers improved image quality for stroke detection on the company’s Swoop® system, an FDA-cleared AI-powered portable MRI device for brain imaging. According to the company, the multi-direction DWI sequence produces clearer, more consistent images by acquiring and averaging signals from multiple directions, similar to methods used in high-field MRI scanners.
This enhancement allows for better visualization of stroke lesions, improving sensitivity for detecting smaller strokes and providing greater specificity in distinguishing true infarcts. The company noted that both the new multi-direction DWI sequence and the existing single-direction sequence will remain available on 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, Hyperfine Chief Medical Officer. He added that the technology is particularly valuable for critical care settings, including cardiac ICUs and emergency department triage.
The new capability represents the first advancement in Hyperfine’s Optive AI™ software and was cleared six months after the initial software clearance. The company positions this development as a significant expansion of the Swoop® system’s clinical capabilities in acute neurological care.
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