AIRS Medical Gains FDA 510(k) Clearance for Expanded Use of SwiftMR™

AIRS Medical, a leading provider of AI-powered healthcare solutions, has announced that its SwiftMR™ software has received FDA 510(k) clearance for expanded indications. Initially cleared in October 2021 for brain MRI images, SwiftMR™ can now enhance MRI images of the spine, knee, ankle, shoulder, and hip.

Expanding MRI Capabilities with SwiftMR™

SwiftMR™ utilizes advanced deep learning technology to significantly enhance MRI image quality, improving productivity without requiring additional scanner purchases or upgrades to existing MRI equipment. This expansion allows healthcare providers to use SwiftMR™ for a broader range of MRI applications, streamlining diagnostic processes and improving patient outcomes.

Key Benefits SwiftMR™

  • Enhanced Image Quality: Employs fine-tuned deep learning algorithms to produce clearer, more detailed images.
  • Cost-Efficient: Increases MRI productivity without the need for new hardware or upgrades to existing MRI machines.
  • Broad Application: Now approved for use with brain, spine, knee, ankle, shoulder, and hip MRI images.

“We are proud to achieve this expanded FDA 510(k) clearance for SwiftMR™,” said Hyeseong Lee, CEO of AIRS Medical. “The FDA is one of the most reputable medical device regulators globally, and this clearance reflects the exceptional quality of SwiftMR™. We are excited to bring SwiftMR™ to more customers through this certification.”

About AIRS Medical

AIRS Medical is at the forefront of transforming healthcare by integrating AI and robotics. With a mission to shift healthcare from reactive treatment to proactive prevention, AIRS Medical’s AI-powered MRI reconstruction solution, SwiftMR™, has redefined medical imaging. By significantly reducing MRI scan times and costs, SwiftMR™ makes early disease screening and diagnosis more accessible. For more information, visit