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?

William Pan: 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?

WP: 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.

HCB News: Please share some of the main benefits to remote reading and migrations to mobile devices?

WP: The main benefits of remote reading and migrating to mobile devices can be best described in three categories starting with mobility. Remote reading can allow radiologist to read exams for multiple hospitals and imaging centers from anywhere they need or want to. Productivity is another important benefit. With the ability to read remotely, a radiologist is reachable whenever and wherever he or she is needed.
The third major benefit is cost efficiency. The average cost of a PACS workstation with a pair of 3 mega pixels diagnostic monitors is about $8,000. The cost of the EBM Rad@ software is $1,200, and pair of iPad Pros are $1,600 for a total of $2,800. Together with the radiologist’s own computer or laptop, they have an FDA approved diagnostic reading workstation.

HCB News: Are you seeing the migration to mobile devices accelerate?

WP: The ability to use mobile devices to do “review” viewing is already happening in the main stream. I believe once the Rad@ product is in the market and allowing radiologists to diagnose on mobile device, the migration to diagnostic reading from mobile devices will accelerate.

In addition, there are key opinion leaders using our system now and will publish their experiences using Rad@ and the impact to their practices and daily lives soon. The findings and experiences of those KOLs will have great influence in the imaging practices and we expect that to drive change and adoption. Our representative was recently at the AHRA meeting and there was a lot of discussion about Rad@ and mobile devices being the next advancement in reading technology.

HCB News: Can you give some examples/anecdotes from your customers about the benefits of Rad that they are receiving by using your mobile device. Productivity, access anywhere, economic, other?

WP: Yes, recently a radiologist from Japan who uses the Rad@ system said that he had been dreaming for years of a solution that would free him up from his office and hospital. Now he can dictate images with his laptop and a voice recorder without going into the office all the time. This has been productive him and his institution.

As I mentioned earlier the setup is rapid and simple involving connecting two iPads lightning-usb cable to Laptop’s USB ports. This solution can have the potential to significantly reduce radiologist and physician travel time and improve efficiency .

HCB News: What were some of the barriers to adoption of mobile? Clearly the major hurdle was FDA and CE approval, but what were some of the others? What about changing habits, physician preference, and other factors?

WP: You are absolutely right about changing habits and radiologist preferences are the major barriers to the adoption of mobile devices. One of the major concerns from our customer feedback is the iPad pro screen size. Many doctors are not accustomed to seeing X-ray images on a 12.9 inches screen. However, I can give a perfect example about clinicians adapting to a new system - the voice dictation system. Ten years ago, most radiologists resisted using voice dictation system because they were so used to having transcriptionists correct their reports. Back then, exam report turnaround time were based on “days”. It was a very inefficient way treat patients. Today, only handful of hospitals have not adopted voice dictation systems; and the exam report turnaround time is based on “hours”. I see the same kind of user adoption will happen with the use of mobile device to make diagnosis

HCB News: Can you explain how your Rad@ system works with multi-vendor PACS and RIS systems? Is it proprietary?

WP: Rad@ is a unique mobile software product that can turn an off-the-shelf iPad device into an extension of diagnostic quality image display monitor. Radiologists can use current hospital PACS software that runs on a Microsoft Windows OS computer and/or laptop. Rad@ renders image pixels value on the Microsoft Windows platform to IOS device and the DICOM curve is applied to the pixel before it is display on the iPad device. Rad@ runs independently in the background and has no interaction with other software. It work with any PACS and RIS software without interfering. To reiterate, Rad@ is not intended to replace the PACS diagnostic monitor, but rather to offer radiologists a reading solution when there is no PACS diagnostic workstation available.

HCB News: What are some of the limitations to traditional medical displays?

WP: Portability- current diagnostic reading station technology with FDA approved diagnostic reading monitor is bulky, heavy, and difficult to transport. As I mentioned, the average cost of a PACS workstation with a pair of 3 mega pixels diagnostic monitors is about $8,000. It is very costly to deploy to all the locations where radiologists and ED physicians can conveniently read exam images. These limitations can be eliminated with Rad@ solution reading with iPad Pro. It is a much simpler and mobile turnkey solution. An anaology is like the old huge mobile phone and how heavy it was to carry around. Nowadays, cell phones are light, sleek, with functions beyond making calls. It won’t be long before traditional medical displays are seen that way.

HCB News: When reading remotely, what are the issues with HIPAA and HiTech Acts? What about other security concerns?

WP: As stated earlier, Rad@ is an application making iPad Pro a monitor extension and it only deals with screen display. Once the device is turned off, all image pixel data on the screen is erased. Therefore, there is no HIPAA concern. We use lightening cable instead of Wi-Fi to get signal so there is no security concerns.