Wednesday, June 25, 2025

Hyperfine, Inc. Receives FDA Clearance for Updated AI-powered Software with Improved Image Quality for All Swoop® System Sequences

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Hyperfine, Inc., the 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.

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“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.”

SOURCE: BusinessWire

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