News | Magnetic Resonance Imaging (MRI) | January 09, 2024

The latest software, the eighth generation of Swoop system software, has obtained CE and UKCA approval

The latest software, the eighth generation of Swoop system software, has obtained CE and UKCA approval

Hyperfine, Inc. has redefined brain imaging with the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system—the Swoop system (Photo: Business Wire)


January 9, 2024 — Hyperfine, Inc., a medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop system—announced the launch of the AI-powered eighth generation of Swoop system software. The software’s diffusion-weighted imaging (DWI) AI denoising feature received U.S. Food and Drug Administration (FDA) clearance in October 2023, and it has been rolled out at select sites over the past several weeks through a limited market release. The latest software improves Swoop system image quality and introduces valuable ease-of-use features, including a real-time aid for more precise patient loading and positioning and a streamlined image upload process.

With CE and UKCA certifications for this latest software, Hyperfine, Inc. is well positioned for future international expansion, bringing the Swoop system to a broader global market.

“Our latest AI-powered software, the eighth generation of our proprietary software platform, embodies our commitment to supporting clinicians in critical decision-making,” remarked Tom Teisseyre PhD, Chief Operating Officer of Hyperfine, Inc. “Our focus on image quality with this latest software has been on the DWI sequence, which is key in stroke imaging. Since its first FDA clearance in 2020, we’ve been dedicated to continually enhancing image quality and workflow efficiencies to define best-in-class, user-centric, ultra-low field MR brain imaging.”

Over 50 exams were performed in hospitals taking part in the limited market release phase, and users commented favorably on DWI image quality. Participating sites confirmed that the new streamlined upload feature materially shortened upload completion times, and the fast-positioning check was a time-saving aid and helped improve image acquisition.

“The software update on the Swoop system has been most beneficial to our workflow. We are now able to view each series as it is being performed and can communicate with the technologist whether additional series are needed. Additionally, we can communicate with clinicians any critical findings in real-time without having to wait for the whole study to be completed," said Jennifer Villa Frabizzio MD, neuroradiologist, Radiology Group of Abington.

Hyperfine, Inc. will roll out software updates for the Swoop system to users in the coming weeks.

For more information: hyperfine.io


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