AIRS Medical Earns Expanded MDR Certification for AI-Powered MRI Image Enhancement Solution SwiftMR™

SEOUL, South Korea, July 8, 2025 /PRNewswire/ — AIRS Medical, a leader in AI solutions for diagnostic imaging, has received Medical Device Regulation (MDR) certification from the European Union (EU) for SwiftMR across all body parts. This expanded certification facilitates broader clinical use of SwiftMR in Europe — giving providers new tools to care for a wider range of patients.

About MDR certification

MDR certification is the EU’s rigorous regulatory process for ensuring the safety and performance of medical devices, including software like SwiftMR that interacts with imaging systems. This comprehensive evaluation conforms with applicable regulatory requirements.

SwiftMR’s MDR certification now extends to all body parts — including abdomen, breast, prostate, and pediatric imaging — in addition to previously approved applications for brain, spine, and musculoskeletal imaging. This designation further expands SwiftMR’s clinical utility across a wide range of MRI exams.

“Earning expanded MDR certification reflects AIRS Medical’s commitment to delivering solutions that hold up to the world’s most demanding regulatory standards,” said Jayden Jung, Head of EMEA. “Today, faster MRI is more accessible across Europe than ever before.”

Expanding access to care

Used by over 800 hospitals, imaging centers, and diagnostic clinics worldwide, SwiftMR uses deep learning technology to reduce MRI scan times by up to 50%¹, which can help improve comfort for patients who may struggle with longer exams, such as those with anxiety, claustrophobia, or acute pain.

By shortening scans while maintaining image quality, SwiftMR enables imaging providers to serve more patients, support timely diagnoses, and expand access to essential care — including for those who might otherwise delay or avoid imaging due to discomfort.

Boosting operational performance

In addition to patient benefits, SwiftMR delivers measurable value for imaging providers:

• Image enhancement – AI-powered enhancement improves resolution and detail, supporting radiologist interpretation.
• Workflow efficiency – Imaging centers use SwiftMR to increase throughput and reduce scheduling bottlenecks.
• Flexible utility – SwiftMR is compatible with all scanner vendors and models, from older low-field systems to advanced high-field machines.
• Seamless implementation – SwiftMR fits into existing workflows, no hardware updates needed.

About AIRS Medical

AIRS Medical is a recognized leader in AI-powered diagnostic imaging and has been named one of the world’s top digital health companies. The company’s flagship product, SwiftMR, has earned multiple awards^2,3 for its speed in MRI, and the team behind it has been celebrated as innovators in AI. Driven by a mission to expand access to preventive healthcare, AIRS Medical is at the forefront of MRI efficiency, enabling imaging centers to serve more patients and deliver essential care to their communities.

To learn more about AIRS Medical, visit https://airsmed.com/en/.

Julia Habeck
AIRS Medical
Senior Marketing Manager, EMEA
julia.habeck@airsmed.com
+49 40 82211839

¹ For investigational purposes in countries outside of the United States, South Korea, Canada, Brazil, Japan, Taiwan, Malaysia, Saudi Arabia, UAE, Thailand, Vietnam, Indonesia, Israel, Australia, New Zealand, Hong Kong, South Africa, Singapore and India. FDA 510(k)-cleared to support images with scan time reduction by up to 50% in the United States.
² AIRS Medical Applauded by Frost & Sullivan for Reducing MRI Equipment’s Exam Wait Times with Its SwiftMR Technology
³ World’s Best Digital Health Companies 2024

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SOURCE AIRS Medical