Hyperfine, Inc. announced that it has enrolled the first patient in a prospective, multi‑center study designed to evaluate the feasibility and imaging benefits of contrast‑enhanced ultra‑low‑field portable MRI using its Swoop system. The enrollment, completed on January 15, 2026, marks the first step toward expanding the device’s intended use to include gadolinium‑based contrast agents.
The study is structured to support a U.S. Food and Drug Administration 510(k) submission by the end of 2026. By demonstrating safety and image quality with contrast, Hyperfine aims to broaden the clinical applications of the Swoop system to include brain tumors, suspected abscesses, and inflammatory conditions such as multiple sclerosis, thereby unlocking new market opportunities and strengthening its competitive position in the portable MRI segment.
Hyperfine’s recent momentum includes FDA clearance for a new multi‑direction diffusion‑weighted imaging software sequence that enhances stroke detection, the first commercial sales of its next‑generation Swoop system powered by Optive AI software, and a peer‑reviewed publication highlighting the economic benefits of the Swoop system in acute hospital care. The company also reported preliminary, unaudited fourth‑quarter 2025 financial results, indicating continued investment in product development and market expansion into emergency departments, neurology offices, and international markets such as India.
Chief Operating Officer Tom Teisseyre said, “Seeing contrast at ultra‑low field strengths is an exciting expansion opportunity for the utility of the Swoop system. The ability to use gadolinium‑based contrast agents could enhance its clinical utility, particularly in cases where contrast is commonly used.” Mark Anderson, MD, Chief Medical Officer at CHRISTUS Mother Frances Hospital, a study site, noted, “Contrast‑enhanced MRI is important for evaluating many neurological conditions, and we are looking forward to participating in this study to assess contrast‑enhanced imaging with the Swoop system.”
While specific market reaction data are not available, the study’s successful enrollment signals a significant step toward regulatory approval and broader clinical adoption, positioning Hyperfine to capture a larger share of the growing portable imaging market.
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