By C.A. Wolski
Calgary Scientific, Calgary, Alberta, recently received clearance from the US Food and Drug Administration (FDA) for its ResolutionMD software to be used as an app on Android devices, including the Samsung Galaxy.
The Android app follows the company’s successful implementation of the software on the iPhone and iPad in 2011. ResolutionMD received clearance from the FDA in 2009. It is also CE marked in Europe and is licensed by Health Canada.
According to Pierre Lemire, president and CTO of Calgary Scientific, the clearance process consisted of both lab trials, which looked at how the device operated to make sure it was optimal for radiologists and other users. For instance, Lemire said that testing included measuring the reflection of light from the Android screen.
After lab testing, the Android version of ResolutionMD underwent clinical testing. This consisted of reading the same study in three situations using the mobile device in a normal hallway, in a reading room setting, and on a reference device. The results were then compared. The company followed a similar protocol when it was seeking clearance for use of ResolutionMD on Apple’s IOS devices.
While the tests were successful, the company did have to make some adjustments. “We did have to add an ambient light setting,” Lemire noted. This means that when a user first logs onto the app and before a study is loaded, a test image comes so the light levels can be adjusted.
According to Lemire, the FDA indication for use of the ResolutionMD for diagnostic purposes is only if a workstation is not available. “The physician needs to use their own judgment about when it is appropriate to use the mobile version,” Lemire said.
The mobile version of the ResolutionMD connects to a local PACS using the web. The app is HIPAA compliant and completely secure, and has a number of features that make it even more so, according to Lemire. The system relies on the same infrastructure as the workstation version, but allows the user to turn off the patient metadata, so they can simply view an image.
Further, the server is just sending a “snapshot” of the image to the mobile device, so when the user exits or the session times out on the device, the image is not stored on the device. “The security angle for ResolutionMD is huge,” said Lemire. “It’s another benefit. We don’t have to wait for the entire data set. The image is pushed out immediately.”
This doesn’t mean that the user is getting a truncated version of the study. Users can view images in every configuration, including 3D, allowing them to flip through the various viewing types. The app also allows for real-time collaboration with other clinicians using mobile devices.
The value of the ResolutionMD app was put to the test in a 2012 Mayo Clinic study that found that clinicians using the mobile device versus a traditional PACS workstation were able to access CT scans of stroke patients 24% faster, saving an average of 11 minutes per patient.
Lemire noted that the app has educational value as well, allowing fellows to look at a case as it is happening. “It helps to reduce the cost of training,” said Lemire.
Lemire said that the company is constantly adding new features and more capabilities to the ResolutionMD app. For instance, he said, the company is working to improve the collaboration feature. Calgary Scientific also is working to expand the app’s reach. It is now available in 12 languages, and the company is working to get additional clearance in these linguistic regions.
Of course, with the speed of technology and the never-ending evolution of mobile apps, there may be a concern that users will find that as they hold onto their devices, they will be left in the proverbial dust with their “old” devices no longer able to support the app. Lemire put this fear to rest. “We will support legacy platforms for as long as it’s reasonable,” he said.
