Portable MRI System Gets FDA Nod for AI-Powered Brain Imaging Software

The Food and Drug Administration (FDA) has granted 510(k) clearance for upgraded brain imaging software utilized with the Swoop® Portable MR Imaging System (Hyperfine).

The software includes an increased signal-to-noise ratio for diffusion-weighted magnetic resonance imaging (MRI) sequences as well as 10 percent increases in the fields of view for T1, T2 and FLAIR sequences that facilitate enhanced imaging of pathology deep in the brain, according to Hyperfine.

“The latest Swoop software improves image quality with notable improvement of the DWI images. The improved image quality more clearly displays underlying brain structure, further accentuating diffusion positivity and potentially increasing confidence in image interpretation and clinical decision-making,” noted Edward Knopp, M.D., the senior medical director of Hyperfine.

Hyperfine noted this is the 11th FDA clearance for the Swoop Portable MR Imaging System following the initial FDA clearance for the device in 2020 and nine subsequent clearances for hardware and software improvements.

In a related study, researchers, presenting data at the recent International Stroke Conference in Dallas, found the Swoop Portable MR Imaging System may enable physicians to perform baseline post-op assessments of heart rate and blood pressure changes that may contribute to brain injury in stroke patients who undergo a thrombectomy.

“We believe these observations set the stage for using portable MRI in the dynamic environment of acute stroke intervention where patients are at high risk for ongoing injury,” noted study co-author Kevin Sheth, M.D., a professor of neurology and neurosurgery at the Yale School of Medicine.

(Editor’s note: For related articles, see “New MRI Study Examines Impact of Disparities with Childhood Adversity Exposure on Brain Development,” “What an MRI Study Reveals About Low Alcohol Use During Pregnancy and Fetal Brain Structure” and “Brain MRI Study Shows ‘Significant Abnormalities’ Up to Six Months After COVID-19.”)