par Gus Iversen
, Editor in Chief | September 11, 2018
Recent technological advances in mobile readers promise to transform how radiologists work, heralding in a new era for the practice. HealthCare Business News recently interviewed William Pan, CEO of EBM Technologies regarding the company’s new FDA approved mobile/remote reader for radiology images, and what that portends for the profession.
HCB News: We recently learned that EBM Technologies was granted FDA approval for reading radiology images. Can you describe the process that you went through?
EBM submitted the Rad@ application with FDA in 2016. The process took us six months before FDA approved the Rad@. During the review period, EBM responded to FDA questions and inquiries, provided Rad@ test results from a qualified laboratory, and submitted supporting documents to FDA to proof Rad@ along with an iPad Pro display to meet the diagnostic reading requirements.
HCB News: Aren’t clinicians already reading remotely on mobile devices? What is the difference?
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As of today, it is common for clinicians to have the ability to use their mobile device for “reviewing” radiological exams on Citrix platform that Hospital provide. Migrating from remote reviewing to mobile device is already happening with clinicians but not remote diagnostic reading. That is because by regulation, radiologists can only use FDA cleared devices to diagnose. There are many places radiologists wish they could do their diagnostic reading but are prohibited because of the absence of a PACS diagnostic workstation. With EBM Rad@ solution, radiologists can now dictate radiological exams in places where previous they could not, and at a fraction cost of the traditional PACS workstation. And because the Rad@ mobile ability, one Rad@ is able to cover multiple locations by simply packing the pair of iPad Pros, going to another computer and /or laptop to transform it to a diagnostic, reading-capable device in less than one minute. It is done by simply connecting two iPads lightening-usb cable to a computer and /or laptop’s USB ports.
EBM saw the needs of radiologists to read exams which can be any given time or place. Rad@ comes in to play, provide the cost-effective mobile reading solution for radiologists.
To be clear Rad@ is not intended to replace PACS diagnostic workstations permanently, but rather to enable radiologists to do their diagnostic reading at a place when there is no PACS diagnostic workstation available. Also it is important to note that Rad@ is not approved for mammography diagnosis.