AIRS Medical Achieves Expanded MDR Certification for SwiftMR™
AIRS Medical, a recognized leader in AI-based solutions for diagnostic imaging, recently announced a significant milestone with the acquisition of expanded Medical Device Regulation (MDR) certification from the European Union for their innovative product, SwiftMR™. This certification now covers MRI imaging for all body parts, marking a pivotal moment in enhancing clinical usage across Europe and providing healthcare providers with sophisticated tools designed to improve patient care.
Understanding MDR Certification
The MDR certification serves as a rigorous regulatory framework established by the EU aimed at ensuring the safety and effectiveness of medical devices, which includes complex software solutions such as SwiftMR. This comprehensive assessment aligns with strict regulatory requirements and demonstrates AIRS Medical's commitment to quality and safety in the health-tech landscape. With the expanded certification, SwiftMR can now assist in various imaging modalities, including abdominal, breast, and pediatric imaging, alongside previously approved applications for brain, spine, and musculoskeletal imaging.
Jayden Jung, AIRS Medical's EMEA regional lead, stated, "The attainment of the expanded MDR certification reflects AIRS Medical’s commitment to delivering solutions that meet the world's highest regulatory standards. Now, faster MRIs are more accessible across Europe than ever before." This notable achievement emphasizes AIRS Medical's continuous dedication to improving patient experience and access to vital healthcare.
Enhancing Access to Healthcare
SwiftMR's technology has already been adopted by over 800 hospitals, imaging centers, and diagnostic clinics worldwide. Utilizing advanced deep learning algorithms, SwiftMR enhances MRI exams by reducing procedure times by up to 50%. This remarkable reduction not only expedites patient throughput but also helps those who experience difficulties during longer scans, such as anxiety, claustrophobia, or acute pain, making essential imaging more manageable.
In shortening scan durations while upholding image quality, SwiftMR enables imaging providers to treat a larger patient population and promotes timely diagnoses. Such quick-access solutions are integral in alleviating the burden of healthcare delays, particularly for those who might otherwise hesitate or avoid necessary imaging procedures due to discomfort.
Operational Excellence
Beyond the enhancements for patients, SwiftMR brings measurable value to imaging providers:
- - Image Enhancement: AI-powered improvements lead to higher resolution and detail, aiding radiologists in their interpretations.
- - Workflow Efficiency: Imaging centers utilizing SwiftMR benefit from increased throughput and reduced scheduling bottlenecks.
- - Flexible Applicability: Compatible with all scanner vendors and models, SwiftMR supports both legacy low-field systems and state-of-the-art high-field machines.
- - Seamless Integration: SwiftMR can be incorporated into existing workflows without the necessity for hardware upgrades, streamlining operational setup.
About AIRS Medical
AIRS Medical stands as a vanguard in AI-driven diagnostic imaging and has been acknowledged as one of the leading digital health companies globally. The flagship product, SwiftMR, has received numerous accolades for its innovations in expediting MRI procedures. The team behind SwiftMR is comprised of innovators committed to advancing healthcare access.
Driven by the mission to widen the availability of preventive healthcare services, AIRS Medical leads the charge in MRI efficiency, enabling imaging centers to extend their reach and provide critical care to their communities. To learn more about AIRS Medical and its offerings, visit
airsmed.com.