Hyperfine gains US FDA clearance for AI-powered software update of Swoop imaging system

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Hyperfine has announced US Food and Drug Administration (FDA) clearance of updated software for its portable magnetic resonance brain imaging technology, the Swoop system.

Built on a “robust” artificial intelligence (AI) foundation, the latest software brings image-quality enhancements to the system’s diffusion-weighted imaging (DWI) sequence, as per a company press release.

With this latest software update, Hyperfine is expanding 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 benefitted from this AI feature, the release adds.

Hyperfine further claims that 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,” said Hyperfine chief operating officer Tom Teisseyre. “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. These imaging improvements will serve a critical role in enhancing image quality for healthcare professionals in time-sensitive environments.”

“Our eighth FDA software clearance in three years for the Swoop system underscores our relentless drive for innovation and continuous improvement,” added Maria Sainz, the company’s president and CEO. “Our focus remains on providing quality brain imaging to more providers and patients in more sites of care. More than milestones, it is about reshaping patient care, empowering clinicians, and advancing brain imaging.”

Hyperfine will roll out the updated Swoop system software in the coming months, the release states.


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