The FDA cleared the new software’s diffusion-weighted imaging (DWI) AI denoising feature in October 2023. Hyperfine began rolling it out at select sites over the past several weeks in a limited market release.
Swoop’s latest updates enhance its image quality and introduce ease-of-use features. Those include a real-time aid for more precise patient loading and positioning, plus a streamlined image upload process. The software also has CE mark and approvals elsewhere to support future international expansion.
The company called Swoop the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system.
Hyperfine said that hospitals taking part in the limited release performed more than 50 exams with Swoop. Users commented favorably on the DWI image quality and noted shortened upload completion times. They also said the fast-positioning check saved time and helped improve image acquisition.
The company plans to roll out the updated Swoop system software in the coming weeks.
“Our latest AI-powered software, the eighth generation of our proprietary software platform, embodies our commitment to supporting clinicians in critical decision-making,” said Tom Teisseyre, of Hyperfine COO. “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.”
