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FDA grants Class II clearance to EBM’s Rad@ remote reading platform
EBM Technologies has scored a Class II FDA clearance for its radiology system, Rad@, for remote, diagnostic reading.
The clearance is expected to untether clinicians using the vendor-neutral solution from their fixed workstations, giving them the mobility to interpret images and make diagnoses in a greater number of locations.
“It is common for clinicians to use their mobile device for reviewing radiological exams on a Citrix platform that hospitals provide,” EBM CEO William Pan said in a statement. “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.”
Before this clearance, radiologists with Rad@ were required to use fixed work areas due to the solution’s absence of a PACS diagnostic workstation. Now, radiologists can view images from a PACS or RIS system for remote diagnostic reading when VPN access is available, and at a fraction of the cost of traditional PACS workstations.
Designed to operate on an off-the-shelf iPad Pro, users can simply connect two iPad Lightning cables to a Windows 8 computer or higher, or laptop USB ports, and then bring in images through Rad@, in less than one minute.
Use of the lightning cables for data transmission also makes the system highly secure, with all image pixel data on the screen erased once the device is turned off. This eliminates HIPAA concerns. In addition, the vendor-neutral nature of the system enables easy adoption without significant disruptions in provider workflow and tasks.
“Anytime a new technology is introduced it is important to avoid unnecessary changes that impact existing workflow, and limiting switching costs,” said Pan. “Vendor-neutrality, therefore, is a very important part of that calculation.”
Headquartered at Neihu Science Park in Taipei City, EBM Technologies operates more than 3500 hospital sites worldwide in parts of Asia and the U.S. It expects to soon enter the Middle Eastern market.
