Calgary Scientific has obtained the US Food and Drug Administration’s (FDA) Class II clearance for ResolutionMD for diagnosis on mobile devices, for all imaging modalities.
The company worked closely with a number of radiologists at a world renowned healthcare organization to clinically validate the image-viewing solution before submitting for the FDA approval. This builds upon the company’s previous approvals for diagnosis using web, iOS and Android devices.
FDA through its safety and effectiveness review found ResolutionMD to be substantially equivalent to PACS or dedicated diagnostic workstations, giving practitioners access to advanced image storage systems and diagnostic tool sets on-the-go.
Healthcare enterprises, across all departments, can now confidently use ResolutionMD to perform a clinical diagnosis on web, iOS and Android devices.
Children’s Hospital of Alabama radiologist-in-chief Dr Stuart Royal noted that the hospital has chosen to implement ResolutionMD because it gives them the ability to quickly disseminate the images from their pediatric imaging departments so that clinicians can provide the fastest and best care and treatment to their patients.
"Their fully accredited, diagnostic image quality and secure solution gives us the flexibility to make clinical decisions from any device type, portable or desktop throughout our healthcare system and off-site," Dr Royal added.