FDA clears Carestream's imaging app for Apple and Samsung devices

By Jonah Comstock
06:36 am

Carestream VUE MotionCarestream has received FDA clearance for VUE Motion, a mobile radiology viewing and reading software that can be accessed on iPhone 4s, iPad 2, Galaxy Note and Galaxy S III mobile devices. Notably, the clearance allows radiologists to read, not just view the images, which means they can make clinical reports based on them.

"If a radiologist has access to other workstations, we recommend that they use those for PACS reading purposes," Neville Skudowitz, Director of Product Management and Strategic Development at Carestream, told MobiHealthNews. "But we all know how the market is being driven today into the teleradiology world. ... That's where the world is going. Radiology is becoming teleradiology and radiologists like to be able to report from wherever they're located wthout having to have specific devices."

Skudowitz said now that they are cleared on these devices, FDA rules will allow them to expand to other iOS and Galaxy devices through internal testing, without having to secure an additional 510(k) clearances.

The company's press release connects the offering to the Bring Your Own Device, or BYOD, phenomenon, whereby healthcare providers are increasingly using their own personal devices, of varying brands, in their work. Skudowitz said the particular devices the company received clearance for were those that a market evaluation showed doctors were using the most.

As we wrote in our tablet report, FDA clearance has been slow to come for mobile radiology viewers because the screen resolution is so essential to the device’s effectiveness -- and that’s linked to hardware, not software. As a result, the first clearances in 2011, like the Mobile MIM radiology app and Calgary Scientific’s ResolutionMD app, were iOS only. Calgary started the Android trend last April when it got clearance on several devices, including the Samsung Galaxy family.

Carestream's software is built on HTML 5 and is cloud-based, which allows both radiologists and referring physicians to access the images from anywhere. The company also uses the same technology to offer the images to the patient on a special patient portal.

"Hospitals can have patients enroll in what we call the MyVue," Skudowitz said. "It provides secure access to patients who will be able to view images when their reports are available, and the availability depends on when the imaging system and the hospital would like to expose those reports. For critical findings, you want to give the referring physician time to speak to the patient before the patient sees the findings in their report."