Reportedly, Hyperfine's Swoop portable brain MRI device has received its eighth FDA 510(k) clearance. This clearance grants clinicians access to enhanced denoising capabilities for diffusion-weighted imaging (DWI) sequences. With the addition of artificial intelligence (AI)-powered denoising, the FDA has approved the use of this technology in DWI sequences with the portable brain MRI system Swoop from Hyperfine. The expanded denoising capability, which was previously added to the device's T1, T2, and FLAIR MRI sequences, aims to provide crisper imaging and improve diagnostic accuracy with DWI sequences. Hyperfine's chief operating officer, Tom Teisseyre, stated that the company believes in making brain imaging more accessible and clinically relevant. He added that this significant update incorporates deep learning into the DWI sequence and will enhance image quality for healthcare professionals in time-sensitive environments. Hyperfine plans to introduce the DWI software update in the near future, following the FDA approval.

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