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FDA Clears AI-Enabled Denoising Feature for DWI Sequences on Portable Brain MRI System


In reportedly the eighth FDA 510(k) clearance for Hyperfine’s Swoop portable brain MRI device, clinicians will now have access to enhanced denoising capabilities with diffusion-weighted imaging (DWI) sequences.

The Food and Drug Administration (FDA) has granted 510(k) clearance for the addition of artificial intelligence (AI)-powered denoising to diffusion-weighted imaging (DWI) sequences with the portable brain MRI system Swoop (Hyperfine).

Hyperfine said the expanded denoising capability, previously added with the device’s T1, T2 and FLAIR MRI sequences, will provide crisper imaging and improved diagnostic accuracy with DWI sequences.

“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, the chief operating officer of Hyperfine. “These imaging improvements will serve a critical role in enhancing image quality for healthcare professionals in time-sensitive environments.”

The company added the FDA nod is the eighth 510(k) clearance for the Swoop device and plans to add the DWI software update in the coming months.

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