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AIRS Medical Achieves Expanded MDR Certification for SwiftMR Imaging Solution

AIRS Medical, a leader in artificial intelligence solutions for medical imaging, has recently announced its achievement of the expanded Medical Device Regulation (MDR) certification for their innovative SwiftMR solution. This certification marks a pivotal milestone, as it broadens the application of SwiftMR for clinical use across Europe, allowing healthcare providers to cater to a wider array of patients.

Understanding MDR Certification

The MDR certification is a rigorous regulatory process set by the European Union (EU) aimed at ensuring the safety and performance of medical devices, including software applications like SwiftMR that work with imaging systems. This thorough evaluation encompasses the necessary regulatory requirements, providing assurance to healthcare providers about the reliability and effectiveness of the technology being utilized.

With this new certification, SwiftMR is now authorized for use across all body parts, including imaging applications for the abdomen, breast, prostate, and pediatric areas. Previously approved for brain, spine, and musculoskeletal imaging, this extended certification significantly enhances the clinical utility of SwiftMR, allowing it to serve a broader spectrum of diagnostic imaging needs.

Commitment to Quality and Accessibility

Jayden Jung, the Director of EMEA at AIRS Medical, emphasized the company’s dedication to quality and compliance, stating, “Receiving the expanded MDR certification reflects our commitment to delivering solutions that meet the world’s most stringent regulatory standards. Now, faster MRI scans are more accessible than ever throughout Europe.”

The SwiftMR technology is already in use at over 800 hospitals, imaging centers, and diagnostic clinics worldwide. The platform harnesses deep learning capabilities to reduce the duration of MRI scans by up to 50%. This reduced time is crucial for enhancing patient comfort, particularly for those who might struggle with longer examinations due to anxiety, claustrophobia, or acute pain.

By shortening scan times while maintaining superior image quality, SwiftMR allows diagnostic imaging providers to see more patients, expedite timely diagnoses, and expand access to essential healthcare services, especially for those that might otherwise defer imaging due to discomfort.

Operational Benefits for Imaging Providers

In addition to benefits for patients, SwiftMR offers measurable advantages for diagnostic imaging service providers:

• - Enhanced Image Quality: The AI-driven enhancements improve resolution and detail, aiding radiologists in interpretation.
• - Workflow Efficiency: Imaging centers employ SwiftMR to boost productivity and mitigate scheduling bottlenecks.
• - Versatile Application: SwiftMR is compatible with a wide range of scanner manufacturers and models, from older low-field systems to advanced high-field equipment.
• - Seamless Integration: The technology integrates smoothly into existing workflows, eliminating the need for hardware upgrades.

About AIRS Medical

AIRS Medical stands out as a recognized leader in AI-powered diagnostic imaging solutions and has been acknowledged as one of the world’s leading digital health companies. SwiftMR, the flagship product of AIRS Medical, has garnered multiple accolades for its rapid MRI capabilities, and the team supporting it has been celebrated for their innovative contributions to AI technology. Driven by a mission to expand access to preventive healthcare, AIRS Medical is at the forefront of enhancing MRI efficiency, allowing diagnostic centers to treat more patients and provide essential care to their communities.

For more information about AIRS Medical and its groundbreaking technologies, visit AIRS Medical's website.