FDA Clears EBM Technologies’ Remote Diagnostic Reading of Radiological Images

EBM Technologies announced that its vendor-neutral, remote reading system Rad@ has been granted Class II FDA clearance for diagnostic reading of radiological images. This clearance has the potential to change the way radiologists work, untethering them from traditional fixed workstations and paving the way for greater work flexibility and financial efficiencies. The company submitted the Rad@ application with FDA in 2016 and was granted clearance in January 2017. As a result, radiologists can now interpret images and make diagnosis independent of their location.
 
EBM saw the need for radiologists to read exams anywhere, any time and set out to develop a vendor-neutral system which could turn an off-the-shelf iPad Pro into a medical display. The sophisticated system allows radiologists to view images from any PACS/RIS system for remote diagnostic reading when VPN access is available. Prior to this clearance, they were prohibited because of the absence of a PACS diagnostic workstation. With EBM’s Rad@ solution, radiologists can now dictate radiological exams in places where previously they could not, and at a fraction cost of the traditional PACS workstation.
 
Highly portable, radiologists simply need to pack a pair of iPad Pros and transform them into diagnostic, reading-capable devices which can be achieved in less than one minute. Users simply connect two iPad lightning cables to a Windows 8 or above computer, or laptop USB ports, then bring in images through Rad@. The system is highly secure as it uses lightning cables for data transmission to ensure solid data security. Once the device is turned off all image pixel data on the screen is erased, eliminating HIPAA concerns.
 
According to EBM CEO William Pan, “It is common for clinicians to use their mobile device for reviewing radiological exams on a Citrix platform that hospitals provide. Migrating from remote reviewing to mobile devices was already happening with clinicians, but not for remote diagnostic reading. Due to regulations, radiologists could only use FDA cleared devices to diagnose. We now provide them with the solution-Rad@, and there is a lot of excitement about it in the community.”
 
Pan continued stating that, “Any time a new technology is introduced it is important to avoid unnecessary changes that impact existing workflow and limiting switching costs. Vendor neutrality, therefore, is a very important part of that calculation.”