Hyperfine has secured CE marking and UK Conformity Assessment (UKCA) approvals for its Optive AI software, enhancing the image quality of its Swoop portable MRI system.
Optive AI software is designed to improve imaging processes, including noise cancellation, image acquisition, and reconstruction, resulting in clearer brain images.
It is compatible with existing Swoop systems without requiring hardware changes, allowing current users to experience improved AI-driven image quality.
The CE mark and UKCA approvals for the Optive AI software follow the US Food and Drug Administration (FDA) clearance, granted in May this year.
The approvals enable Hyperfine to extend access to its AI-powered imaging technology in European markets, a significant step in its commercial expansion worldwide.
Hyperfine president and CEO Maria Sainz said: “Optive AI software delivers a substantial improvement in image quality, which improves diagnostic confidence and enables broader use in a variety of clinical settings.
“We are excited to bring these advancements to clinicians and patients in the EEA and the UK to drive global adoption of our Swoop system.
“These approvals underscore our commitment to operational excellence and global expansion, and achieving them so quickly after our US FDA clearance is a testament to the strength of our regulatory and product teams.”
The Swoop Portable MR Imaging (V2) System is a portable, ultra-low-field MRI device approved for brain imaging in patients of all ages.
It is designed to provide images of the head’s internal structure, aiding in diagnosis when full diagnostic examinations are impractical.
The system is already in use across European markets for paediatric, critical care, stroke, and neurodegenerative patient care.
Hyperfine plans to distribute the Optive AI software to Swoop users in the European Economic Area and the UK by the fourth quarter of 2025, with local language support.
University of L’Aquila neurology head Simona Sacco said: “In L’Aquila, over the last few months, we have been leading a project with two other Italian centres to use the Swoop system for stroke triage.
“The new Optive AI software, with the latest AI from Hyperfine, provides a very significant upgrade in image quality and opens additional opportunities to deploy the Swoop system clinically for easier and more efficient access to MRI in healthcare systems.”
