The US Food and Drug Administration (FDA) has granted Class II FDA clearance for EBM Technologies' vendor neutral, remote reading system Rad for diagnostic reading of radiological images.
Image: EBM Technologies secures FDA clearance for Rad@. Photo: Courtesy of Tyler Franta/Unsplash.
The the vendor neutral, iPad Pro-based Rad@ system enables radiologists to see images from any PACS/RIS system for remote diagnostic reading when VPN access is available.
EBM stated that the system untethers radiologists from fixed workstations, paving way for better work flexibility and financial efficiencies.
Application for Rad@ system was submitted by the company to the FDA in 2016 and was granted clearance in 2017.
Before this clearance, radiologists were prohibited because of the absence of a PACS diagnostic workstation. With the company’s Rad@ solution, radiologists can now dictate radiological exams in places where they could not previously and at a fraction cost of the traditional PACS workstation.
Now radiologists only need to carry a pair of iPad Pros and can transform them into diagnostic, reading-capable devices in less than a minute. They need to connect two iPad lightning cables to a Windows 8 or above computer, or laptop USB ports, then bring in images through Rad@.
This system is claimed to be 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.
EBM CEO William Pan said: “It is common for clinicians to use their mobile device for reviewing radiological exams on a Citrix platform that hospitals provides. 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 saying: “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.”