Calgary Scientific Receives FDA Clearance for Mobile Diagnosis on All Modalities
April 11, 2014 — Calgary Scientific Inc. announced their latest Class II clearance from the U.S. Food and Drug Administration (FDA). Its enterprise image-viewing solution, ResolutionMD, is now cleared for diagnosis on mobile devices for all imaging modalities. Calgary Scientific worked closely with a number of radiologists to clinically validate the solution prior to submitting to the FDA. This builds upon their previous clearances for diagnosis using web, iOS and Android devices.
“We chose to implement ResolutionMD because it gives us the ability to quickly disseminate the images from our pediatric imaging departments so that clinicians can provide the fastest and best care and treatment to our patients,” said Stuart Royal, M.S., M.D., radiologist-in-chief at Children’s Hospital of Alabama. “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."
The FDA's safety and effectiveness review of ResolutionMD found it to be substantially equivalent to PACS (picture archiving and communications systems) or dedicated diagnostic workstations, giving practitioners access to advanced image storage systems and diagnostic tool sets on-the-go. Gaining this clearance means a healthcare enterprise, across all departments, can use ResolutionMD to perform a clinical diagnosis on web, iOS and Android devices, as it has been through a rigorous testing process as agreed to by the FDA.
“We are excited to deliver this clearance to the institutions that rely on ResolutionMD to improve patient care,” said Pierre Lemire, president and CTO of Calgary Scientific. “This is also an important advancement for all our valued partners, including those who deliver custom-branded solutions, as they will be added under the Calgary Scientific registration with the FDA.”
For more information: www.calgaryscientific.com/resolutionmd
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