AI-Powered MRI Software Gets Expanded FDA Clearance for Use with Deep Learning Reconstruction Modalities

The Food and Drug Administration (FDA) has granted an expanded 510(k) clearance for the use of the MRI-based AI software SwiftMR in tandem with deep learning (DL) reconstruction software from original equipment manufacturers (OEMs).

AIRS Medical, the manufacturer of SwiftMR, said the use of the AI software can provide additional reduction in MRI scan time beyond the capabilities of OEM DL products. In one example, AIRS Medical said the SwiftMR software reduced the scan time for accelerated brain MRI scans by six minutes for a facility utilizing a GE HealthCare 3T MRI scanner with AIR Recon DL.

The company added that the SwiftMR software also provides coverage of MRI sequences that may not be available with existing OEM DL platforms.

"Over the past year, we trained SwiftMR specifically on OEM DL-processed images and tested it across multiple vendors and field strengths. This new FDA clearance confirms that it meets the standard for quality and gives our customers the confidence to deploy SwiftMR alongside OEM DL solutions,” noted Woojin Jung, PhD, head of product at AIRS Medical.