October 12, 2023 — Hyperfine, Inc., a groundbreaking 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 FDA clearance of updated software. Built on a robust AI foundation, the latest software brings image quality enhancements to the Swoop system’s diffusion-weighted imaging (DWI) sequence.
With this latest software update, Hyperfine, Inc. expands the Swoop system’s AI denoising capabilities by incorporating advanced image post-processing into the DWI sequence. The system’s other sequences (T1, T2, and FLAIR) previously benefited from this AI feature. Denoising enables a crisper image that potentially helps clinicians more accurately diagnose, treat, and monitor patients undergoing brain imaging.
“We believe in making brain imaging more accessible, clinically relevant, and actionable. We continue to make meaningful progress across all sequences. With this significant and most recent update, we now incorporate deep learning into our DWI sequence,” said Tom Teisseyre, chief operating officer of Hyperfine, Inc. “These imaging improvements will serve a critical role in enhancing image quality for healthcare professionals in time-sensitive environments.”
Maria Sainz, president and CEO of Hyperfine, Inc., remarked, “Our eighth FDA software clearance in three years for the Swoop system underscores our relentless drive for innovation and continuous improvement. Our focus remains on providing quality brain imaging to more providers and patients in more sites of care. More than milestones, it's about reshaping patient care, empowering clinicians, and advancing brain imaging.”
Hyperfine, Inc. will roll out the updated Swoop system software in the coming months.
For more information: www.hyperfine.io
Related content:
Viz.ai Partners with Hyperfine to Enable New MR Imaging and Workflow Paradigm
Hyperfine’s Portable MRI System Demonstrates High Accuracy for Detection of Brain Hemorrhage
March 30, 2026 
