FDA Approves AIRS Medical’s SwiftMR™ for Expanded Use: Here’s What it Means

SwiftMR™, the artificial intelligence (AI)-powered solution for magnetic resonance imaging (MRI) that enables scan time reduction and image quality enhancement, was previously approved in the United States for images of the brain, spine, knee, ankle, shoulder, and hip in adults. Following an expanded 510(k) clearance from the Food and Drug Administration (FDA), it can now be used on all body parts and patients.

Benefiting Patients

The FDA’s 510(k) process is a comprehensive review designed to examine the safety and efficacy of medical devices like MRI scanners. In 2021, the FDA approved SwiftMR™ for brain scans in adults. A year later, the regulatory agency authorized AIRS Medical’s AI technology for use in  spine, knee, ankle, shoulder, and hip scans — likewise in adults. With the latest ruling, however, SwiftMR™ can be used for all indications and patients, including children.

As a result, patients of all ages undergoing various ailments will reap the rewards. Not only will they avoid discomfort caused by prolonged scans — SwiftMR™ cuts scan times by up to 50% — but radiologists will have higher-quality images to read. This, in turn, will generate better patient outcomes.

Benefiting Imaging Centers

It’s not just patients (and the technicians and radiologists who use the machines) who gain from the FDA’s expanded approval. Consider this: With faster scan times, radiology centers can now dramatically increase the number of patients they see. What’s more, they don’t need to invest in additional scanners to do it.

Looking Ahead

From the start, AIRS Medical has embraced AI as a force for good. CEO Hyeseong Lee reflected on the matter:

“This clearance not only underscores SwiftMR™’s exceptional quality but also illustrates AIRS Medical’s dedication to the highest standards of regulatory compliance. We are looking forward to bringing SwiftMR™ to more customers through this certification.”

– Hyeseong Lee, CEO

Trusted by over 300 institutions in more than a dozen countries, SwiftMR™ is revolutionizing MRI through AI. See how you can improve patient outcomes and generate revenue with our technology. Contact us today.