Hyperfine Achieves breaks CE Mark and UKCA Approval for Optive AI™ Software for Portable MRI Technology

Hyperfine, Inc. has secured both CE Marking and UK Conformity Assessment (UKCA) approval for its Optive AI™ software. 

These approvals follow US FDA clearance and represent a major step in expanding access to the company’s AI-driven imaging technology in Europe and the UK.

Optive AI™ software improves every stage of the imaging process, from noise reduction and image capture to reconstruction and post-processing. 

This upgrade produces clearer, more consistent brain images with sharper anatomical detail. The software works with all first-generation Swoop® portable MRI systems and does not require any hardware changes, enabling existing users to benefit immediately.

The new software will support clinical use across paediatric, emergency, stroke, and neurodegenerative care settings. 

Sites in Europe are already using the Swoop® system, and Hyperfine plans to begin deploying Optive AI™ to existing customers in the European Economic Area and the UK from the fourth quarter of 2025, including local language support.

The approval is expected to enhance diagnostic confidence, improve operational efficiency, and widen access to MRI scans. It also strengthens Hyperfine’s global commercial strategy by enabling more healthcare providers to adopt its portable MRI technology.