Hyperfine’s Swoop portable MRI system has secured FDA clearance for its V2 model with Optive AI software, delivering unprecedented image quality via redesigned hardware and AI-enhanced signal-to-noise ratios. The ultra-low-field device, weighing 2,000 pounds, enables full-brain scans at any bedside without patient transport, reducing stroke diagnosis time by 40% and costs by 80% compared to traditional 1.5T machines. Cleared for all ages, it supports neurology offices and hospitals, with pilots at UNC Health showing resolution approaching conventional scanners. This 10th software iteration incorporates five years of global data, improving uniformity and acquisition speed for trauma, pediatric, and critical care cases, potentially revolutionizing access in rural/remote settings and expanding Hyperfine’s market.
Source: Hyperfine Press & Business Wire
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