www.fdanews.com/articles/205405-airs-medical-gets-510k-clearance-for-swiftmr-ai-reconstruction-software
Airs Medical Gets 510(k) Clearance for SwiftMR AI Reconstruction Software
November 18, 2021
South Korea-based Airs Medical has received the FDA’s 510(k) clearance for its first product, SwiftMR, which uses artificial intelligence (AI) to improve low-quality MRI images.
Radiologists often sacrifice MRI image quality to keep scan times at a level that patients can tolerate, so the ability to improve image quality using software is very helpful and can increase their productivity.
The SwiftMR program, which was “trained” using high-quality images, can reconstruct the lower-quality images and send them directly with the healthcare institution’s picture archiving system.