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.
GE HealthCare Debuts AI-Powered Cardiac CT Device at ACC Conference
April 1st 2025Featuring enhanced low-dose image quality with motion-free images, the Revolution Vibe CT system reportedly facilitates improved diagnostic clarity for patients with conditions ranging from in-stent restenosis to atrial fibrillation.
New AI-Enabled Portable Ultrasound May Facilitate 50 Percent Reduction in Cardiac Imaging Scan Time
March 28th 2025Artificial intelligence (AI)-powered measurement capabilities provide key features with the Compact Ultrasound 5500CV device, which was unveiled at the American College of Cardiology (ACC) conference.
New Collaboration Offers Promise of Automating Prior Authorizations in Radiology with AI
March 26th 2025In addition to a variety of tools to promote radiology workflow efficiencies, the integration of the Gravity AI tools into the PowerServer RIS platform may reduce time-consuming prior authorizations to minutes for completion.
