Hyperfine Swoop vs Lunit

Hyperfine's Swoop is a portable 0.064T brain MRI that needs no shielded room and has been used at the bedside in ICUs and resource-limited hospitals. Hyperfine says its Optive AI applies deep learning to reduce noise and blur. The vendor rolled Optive AI out to its installed base in July 2025 and received CE and UKCA marks in August 2025, while the FDA list for Swoop runs to K262622 in August 2026. A review lists structural contrasts only, with no contrast-enhanced T1 and lower resolution than 1.5T or 3T. Lunit sells to breast screening sites and chest-film services, with 510(k)s for INSIGHT MMG and DBT and Volpara density tools, and quotes go through a contact form. Hyperfine has no public price. It sells ownership plus an annual service agreement after a one-year warranty, on 36- or 60-month terms, against about $1.2 million for conventional MRI per its 10-K, while an older Scientific Reports paper estimated about $50,000 per system.