Hyperfine Inc. Secures CE Mark and UKCA Approval for Optive AI™ Software, Expanding European Reach of Swoop® MRI System
Hyperfine Inc. has received CE Mark and UKCA approval for its Optive AI™ software, enhancing the image quality of its Swoop® portable MRI system. These approvals will expand access to Hyperfine’s AI-powered imaging software in the European Economic Area and the UK, supporting the company’s global expansion. Deployment to current Swoop® system users in these regions is set to begin in Q4 2025.
Hyperfine Inc., a health technology company, has received CE Mark and UK Conformity Assessment (UKCA) approval for its Optive AI™ software, enhancing the image quality of its Swoop® portable MRI system. These approvals, which come shortly after US FDA clearance, will expand access to Hyperfine’s advanced AI-powered imaging software in the European Economic Area (EEA) and the UK. This milestone supports the company’s global commercial expansion and commitment to improving diagnostic capabilities across various clinical settings. Deployment to current Swoop® system users in these regions is set to begin in the fourth quarter of 2025. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Hyperfine Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250902202329) on September 02, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT)
