Hyperfine has gained CE mark and UK Conformity Assessment (UKCA) approval for its Optive AI software.

The approvals closely follow the U.S. Food and Drug Administration (FDA) clearance. The company said these approvals offer a leap in image quality for the Swoop portable MRI system and expand international access to the latest Hyperfine artificial intelligence (AI)-powered imaging software.

Optive AI software enhances the imaging process from noise cancellation and image acquisition to reconstruction and post-processing. The result is brain images with more clarity, uniformity, and sharper anatomical detail. The software is compatible with first-generation Swoop systems and doesn’t require hardware modifications. This way, current users can benefit from the AI-driven image quality enhancements.

Multiple sites in European markets are using the Swoop system to support care in pediatric, critical care, stroke, and neurodegenerative settings. Hyperfine said it will start deploying software to Swoop system users in the European Economic Area (EEA) and UK in Q4 of this year, with local language support available at launch.

“In L’Aquila, over the last few months, we have been leading a project with two other Italian centers to use the Swoop system for stroke triage,” said Professor Simona Sacco, Head of Neurology at the University of L’Aquila. “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.”

Earlier this summer, the company enrolled the first patients in its PRIME (Portable Rapid Imaging for Medical Emergencies) study. The study will assess the potential of artificial intelligence (AI)-powered MRI technology to transform triage in the emergency department setting.

“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 UK to drive global adoption of our Swoop system,” added Maria Sainz, President and CEO of Hyperfine. “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.”