Hyperfine Swoop vs Subtle Medical

Subtle Medical's 11 openFDA clearances cover software that the vendor says works on existing MR, PET and CT scanners. It describes SubtleHD(MR) as up to 80% faster MRI sequences and SubtleHD(PET) as up to 75% faster scans, and says it is deployed on over 1,300 scanners. AiMIFY, built with Bracco, targets contrast-enhanced brain MRI at a lower gadolinium dose. A center with an MR booking backlog is the target of those vendor-claimed speed-ups, and no price is public. Hyperfine builds reconstruction into the scanner: Optive AI reached its installed base in July 2025 and carries CE and UKCA marks from August 2025. A department that wants contrast-enhanced brain MRI at a lower dose will not get it from Hyperfine, because a review of Swoop use in Malawi notes no contrast-enhanced T1. Which of Swoop's 510(k) records covers Optive AI is unclear.