AIRS Medical Secures EU Certification for Flagship Product SwiftMR™: What it Means
Scanning centers across Europe and its neighboring countries can now offer patients groundbreaking artificial intelligence (AI)-powered magnetic resonance imaging (MRI) technology. The European Union (EU) Medical Device Regulation (MDR) has granted SwiftMR™ CE mark, meaning it can be sold across all EU member states plus Iceland, Liechtenstein, and Norway. What is CE mark? The “CE” […]
FDA Clears 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 cleared 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 […]
AIRS Medical Secures PMDA Certification for Flagship Offering, SwiftMR™
Radiology centers throughout Japan can now benefit from SwiftMR™, the breakthrough artificial intelligence (AI)-powered magnetic resonance imaging (MRI) enhancement solution from AIRS Medical. Here’s everything you need to know. SwiftMR™ deemed safe and effective The Pharmaceuticals and Medical Devices Agency (PMDA), an administrative agency responsible for ensuring medical devices such as MRI scanners are safe […]
AIRS Medical Secures MDSAP Certification: What You Need to Know
SwiftMR™, the artificial intelligence (AI)-powered magnetic resonance imaging (MRI) enhancer from AIRS Medical, is now available in the United States, Canada, Japan, Australia, and Brazil after receiving certification from the Medical Device Single Audit Program (MDSAP). More than 700 million people across these five nations can now enjoy quicker, more diagnostically useful scans while radiology […]
AIRS Medical Gains FDA 510(k) Clearance for Expanded Use of SwiftMR™
AIRS Medical, a leading provider of AI-powered healthcare solutions, has announced that its SwiftMR™ software has received FDA 510(k) clearance for expanded indications. Initially cleared in October 2021 for brain MRI images, SwiftMR™ can now enhance MRI images of the spine, knee, ankle, shoulder, and hip. Expanding MRI Capabilities with SwiftMR™ SwiftMR™ utilizes advanced deep […]
AIRS Medical Gains FDA 510(k) Clearance for AI-Powered MRI Software SwiftMR™
South Korea-based healthcare startup AIRS Medical Inc. proudly announces that its innovative AI-powered MRI reconstruction software, SwiftMR™, has received FDA 510(k) clearance. This cutting-edge software significantly enhances MRI images, improving both efficiency and patient experience. Transforming MRI Imaging with AI MRI scans, though safe and reliable, often require 20-90 minutes, leading to patient discomfort and […]