Guilford, CT-based company Hyperfine has secured the European CE Mark and U.K. Conformity Assessed (UKCA) clearance for its Optive AI software.
The software is designed for use with the company’s Swoop portable MRI brain scan system and enhances image quality throughout the entire acquisition and processing pipeline, Hyperfine said. A notable feature is the software’s backward compatibility with existing Swoop hardware, which will allow current systems to be upgraded without requiring physical modifications, the company added. The rollout to clinical sites is planned for the final quarter of 2025.
Hyperfine received clearance in Europe for its Swoop system in 2024.
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