AIRS Medical Achieves Expanded MDR Certification for SwiftMR™

AIRS Medical's SwiftMR™ Secures Expanded MDR Certification

AIRS Medical has made significant strides in the field of diagnostic imaging with its revolutionary product, SwiftMR™, following the acquisition of expanded Medical Device Regulation (MDR) certification from the European Union (EU). This accomplishment signals an exciting new chapter for the company as it broadens the clinical application of its AI-powered MRI solution across multiple body parts.

Understanding MDR Certification

Medical Device Regulation certification is a comprehensive process enforced by the EU to ensure the safety and efficacy of medical devices, including software that interacts with imaging systems. Through rigorous evaluation, the regulatory process aims to uphold the highest standards for medical devices, ensuring they meet applicable regulatory requirements and deliver optimal performance.

Enhancing Clinical Utility of SwiftMR

The recent expansion of the MDR certification now allows SwiftMR to be utilized for a diverse array of MRI applications, which include abdomen, breast, prostate, and pediatric imaging. This comprehensive approval highlights the versatile capabilities of SwiftMR, reinforcing its use in vital MRI examinations and expanding its clinical utility significantly.

A WORD FROM AIRS MEDICAL

According to Jayden Jung, the Head of EMEA at AIRS Medical, "Acquiring expanded MDR certification demonstrates our unyielding commitment to producing solutions that align with stringent global regulatory standards. Access to faster MRI technology has never been more achievable across Europe." This sentiment underscores AIRS Medical's dedication to fostering innovation and enhancing the quality of care available to patients.

Wider Access to Diagnostic Care

Currently, SwiftMR is in use at over 800 hospitals, imaging centers, and diagnostic clinics globally. Leveraging deep learning technology, SwiftMR can cut MRI scan times by up to 50%, ultimately aiding in delivering comfort to patients who might be anxious or uncomfortable during traditional MRI procedures.

Facilitating Timely Diagnoses

By not only shortening scan duration while maintaining high image quality, SwiftMR allows imaging facilities to cater to a more significant number of patients. This capability plays a crucial role in ensuring timely diagnoses and providing essential medical care, which may otherwise be postponed due to patient discomfort.

Operational Benefits for Imaging Providers

In addition to enhancing patient experience, SwiftMR offers measurable advantages for imaging practices:

• Enhanced Imaging Quality – The AI-driven enhancement capabilities significantly improve resolution and detail, enabling more accurate radiologist interpretations.
• Operational Workflow Improvements – Imaging facilities utilizing SwiftMR experience better throughput and fewer scheduling issues, enhancing overall efficiency.
• Adaptability – SwiftMR is compatible with a variety of scanner vendors and models, ensuring smooth integration regardless of the existing technology.
• Easy to Implement – The system seamlessly fits into current workflows without necessitating hardware modifications, making it a hassle-free upgrade.

About AIRS Medical

AIRS Medical is a trailblazer in AI-driven diagnostic imaging technology. The company has been recognized as one of the leading digital health innovators globally. Its flagship product, SwiftMR, has garnered numerous accolades for enhancing efficiency and effectiveness within the MRI sector. AIRS Medical's mission is to revolutionize access to preventive healthcare, affirming its leadership position in enhancing MRI processes, thereby empowering imaging centers to better meet the healthcare needs of their communities.

To discover more about AIRS Medical and its innovative products, visit their official website.

Frequently Asked Questions

What is MDR certification?

MDR certification is the EU's stringent regulatory framework ensuring the safety and performance of medical devices, including imaging software.

How does SwiftMR benefit diagnostic imaging?

SwiftMR decreases MRI scan times by up to 50%, improving patient comfort and enhancing diagnostic efficiency in imaging centers.

What new applications does SwiftMR cover under the expanded certification?

SwiftMR's extended certification now includes imaging applications for the abdomen, breast, prostate, and pediatric examinations.

How many facilities are currently using SwiftMR?

SwiftMR is currently employed in over 800 hospitals and diagnostic clinics worldwide, demonstrating its broad clinical application and trust in the product.

What is the goal of AIRS Medical?

AIRS Medical aims to expand access to preventive healthcare through innovative AI-powered solutions that improve the diagnostic imaging process.

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