Technology | April 11, 2014

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

Related Content

AI Visualize Inc. Debuts Artificial Intelligence Cloud Image Visualization Platform at RSNA 2017
Technology | Remote Viewing Systems | December 13, 2017
AI Visualize Inc. debuted its new cloud-based artificial intelligence (AI)-based image analysis and viewing platform at...
TomTec Unveils TomTec Zero Cardiovascular Viewing Software
Technology | Remote Viewing Systems | July 24, 2017
TomTec Zero is the latest addition to the TomTec portfolio. Now every physician reading cardiovascular studies at...
MIM Software Inc. Announces Updates to MIM Encore
Technology | Remote Viewing Systems | May 31, 2017
MIM Software Inc. recently announced significant updates to its MIM Encore solution for viewing nuclear medicine images...
MIM Software, FDA clearance, thin client technology, tablets, iPads
Technology | Remote Viewing Systems | May 31, 2016
MIM Software Inc. announced it has received 510(k) U.S. Food and Drug Administration (FDA) clearance to market full MIM...
Technology | Remote Viewing Systems | February 23, 2016
February 23, 2016 — WITS(MD), a provider of medical image workflow solutions, announced a company name change to Imag
Feature | Remote Viewing Systems | November 18, 2015 | Kim Garriott
There is a growing need to exchange and share imaging studies with outside entities.
Overlay Init