Technology | September 27, 2011

Calgary Scientific's ResolutionMD Mobile Receives FDA Clearance for Diagnostic Image Viewing on iPhones and iPads

September 27, 2011 – Calgary Scientific Inc. has received clearance from the U.S. Food and Drug Administration (FDA) to market medical imaging application, ResolutionMD Mobile, as a mobile diagnostic application in the United States. With this secure, highly scalable, server-based software solution, physicians anywhere can rapidly access, view and interact with patient images and reports stored within any healthcare facility, and render a clinical diagnosis using their mobile devices. Prior non-diagnostic versions of this product are currently distributed and licensed under original equipment manufacturer (OEM) agreements with global leaders in medical imaging and information technology. In addition to the recent FDA clearance, ResolutionMD Mobile has also been licensed by Health Canada and bears the CE mark for distribution in Europe.

The ResolutionMD mobile product was purpose-built from the existing ResolutionMD software, which first received FDA clearance in 2006. ResolutionMD Mobile was then mobile-enabled into a state-of-the-art product, utilizing the power of Calgary Scientific's PureWeb platform technology, which allows ResolutionMD to simultaneously support multiple mobile devices and operating systems. This initial FDA clearance applies to versions of the solution running on Apple iPhone and iPad devices. The mobile app offers unparalleled performance; advanced capabilities and complete security; utilizes minimal bandwidth and offers strong performance even on 3/4G wireless; and ensures that no highly sensitive or confidential patient information is ever retained on the mobile device. The patient image data cannot be lost or stolen, as in the case of traditional mobile-device rendered software, which requires that data to be sent to the mobile device. The flexible, highly scalable, and easily installed environment of ResolutionMD Mobile expands the delivery of Calgary Scientific's image-rendering technologies to empower healthcare organizations, physicians and patients to view images and reports, provide significantly enhanced levels of patient care, and reduce healthcare system costs.

"We worked very closely with the FDA to identify and address the challenge of delivering the advanced visualization and integrated PACS functionality of our ResolutionMD server to various mobile devices," said Kyle Peterson, director of regulatory and corporate affairs of Calgary Scientific. "Extensive bench-testing results and reads performed by practicing radiologists using typical but highly challenging cases for [computed tomography] CT and [magnetic resonance] MR were amongst the wide variety of supportive materials and studies submitted to the FDA during the course of this extensive process, which validated the primary diagnostic use of ResolutionMD Mobile."

"The ability to view diagnostic quality images on mobile devices promises to speed healthcare delivery, particularly for urgent conditions or after hours," says James A. Brink, M.D., professor and chair, department of diagnostic radiology at Yale University School of Medicine.

ResolutionMD Mobile capabilities include:

  • Interactive 2-D, MIP/MPR and 3-D advanced visualization
  • Anywhere, anytime access to and fully interactive use of MR and CT images
  • Supports HIPAA Compliance – User authentication and encrypted communications further protect confidential patient information
  • Concurrent support for multiple devices and mobile operating platforms – The solution enables ResolutionMD Mobile capabilities on devices such as the Apple iPhone and iPad, as well as Android devices. Future versions of the server-based software solution will support an expanded list of mobile devices and operating systems, and supplementary applications to the FDA for clinical diagnostic imaging approval on those devices other than the iPhone and iPad will occur in then near future.
  • Ambient Light User Assessment – Provides sample images to the user to assess the viewing suitability of current lighting conditions.

ResolutionMD Mobile is currently available on Apple iPhone and iPad devices through the Apple App Store. A demonstration version (ResolutionMD Mobile Lite) is also available on the Apple App Store, providing access to anonymized patient images. The ResolutionMD Server is available from Calgary Scientific Inc., as well as from its family of global leading OEM partners in medical imaging and information technology.

For more information: www.calgaryscientific.com

 

Related Content

Videos | Mobile Devices | February 16, 2018
DAIC Editor Dave Fornell previews the launch of augmented reality (AR) technology in the March/April 2018 issue of DA
Nine in Ten Clinicians to Use Mobile Technology at Bedside by 2022
News | Mobile Devices | January 31, 2018
Zebra Technologies Corp. announced the results of its Future of Healthcare: 2022 Hospital Vision Study, revealing the...
European Heart Rhythm Association Launches Cardiac Arrest First Responder App
News | Mobile Devices | June 30, 2017
A novel smartphone application has been developed that can direct first responders to cardiac arrest victims more than...
Consumers Warned About Accuracy of Heart Rate Apps in New Study
News | Mobile Devices | May 22, 2017
May 22, 2017 — Consumers are being warned about the accuracy of heart rate apps after a study found huge variability
Spok Survey Confirms Mobile Device Infrastructure Improvements and Diversity in Hospitals
News | Mobile Devices | May 03, 2017
Spok Inc. recently released the second part of the company's annual mobility in healthcare survey. Spok has been...
Xcertia, new alliance, guidelines, mobile health applications
News | Mobile Devices | January 12, 2017
Four organizations have announced they are forming a new, multi-stakeholder collaboration, Xcertia, dedicated to...
smartphones, hospital tranfers, heart attack patients, JACC study, South Korea
News | Mobile Devices | September 23, 2016
Smartphone communication among medical teams at different hospitals can significantly reduce the time it takes for...
mobile health technology, mHealth, privacy and security, Computer magazine study
News | Mobile Devices | July 21, 2016
July 21, 2016 — A new paper published in the June issue of Computer cautions that while...
McKesson, iPad, CVIS, ECG mobile viewer

Dynamic ECG waveforms displayed on an iPad using McKesson's mobile ECG viewer, which directly connects to the hospital's cardiovascular information system or ECG management system. This technology can help speed triage of STEMI patients, allowing diagnosis anywhere, rather than requiring cardiologists to walk down to an emergency department or drive into the hospital to view the ECG.

Feature | Mobile Devices | June 09, 2016 | Dave Fornell
The ubiquitous smartphone has found its way into the pockets of nearly every clinician and patient in recent years an
mobile health apps, FTC, compliance tool, business guidance, privacy
News | Mobile Devices | April 25, 2016
The Federal Trade Commission (FTC) announced that it has created a Web-based guidance tool for developers of health-...
Overlay Init