FDA approves iPad, iPhone radiology app for mobile diagnoses

Posted:
in iPad edited January 2014
The US Food and Drug Administration has approved the first diagnostic radiology app for use in viewing medical images to make diagnoses using Apple's iPad and iPhone, a title that won the Apple Design Award for "Best iPhone Healthcare & Fitness Application" in 2008.



The announcement, made earlier today, gives a green light for Mobile MIM, an iOS app component of secure medical imaging product sold by the Cleveland-based MIM Software.



The FDA said the app "is not intended to replace full workstations and is indicated for use only when there is no access to a workstation," but William Maisel, MD, MPH, the chief scientist and deputy director for science in the FDA?s Center for Devices and Radiological Health, noted that "this important mobile technology provides physicians with the ability to immediately view images and make diagnoses without having to be back at the workstation or wait for film."



The Mobile MIM app allows radiological images to be securely delivered to mobile doctors using an iPad or iPhone, enabling them to view images and make medical diagnoses "based on computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine technology, such as positron emission tomography (PET)."



The app "allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest," the report stated.



A lengthy evaluation



"In its evaluation, the FDA reviewed performance test results on various portable devices," the agency said. "These tests measured luminance, image quality (resolution), and noise in accordance with international standards and guidelines. The FDA also reviewed results from demonstration studies with qualified radiologists under different lighting conditions. All participants agreed that the device was sufficient for diagnostic image interpretation under the recommended lighting conditions."



MIM Software's chief technology officer Mark Cain stats on the company's website that "establishing a diagnostic protocol for medical imaging is no simple matter for a device like the iPhone or iPad. It is critical to understand the characteristics of the device and to establish methods and tools that are safe and effective, while working within those constraints. There has been a gap in the market for a remote imaging device like this, and now it can be filled."



The app is available in 14 languages and in 34 countries in addition to the US. It is expected to become available in the App Store next week, according to the company's site.



«13

Comments

  • Reply 1 of 52
    Helps make the iPhone and iPad more useful in the healthcare industry..
  • Reply 2 of 52
    iPad is...radiological.
  • Reply 3 of 52
    sflocalsflocal Posts: 5,990member
    Amazing that it took almost three years to get the product approved. The FDA doesn't mess around (usually) in the healthcare industry. Since it's mainly more a hardware reason than software reason, I wonder if there are Android apps in the works as well. The build quality of those units are much lower.
  • Reply 4 of 52
    Absolutely huge. Takes the possibilities associated with this medium to the next level.



    The technological constraints, combined with medical complexities involved, are non-trivial. The CTO's statement that it was ".....no simple matter" is spot on.



    Kudos to the folks involved, the FDA, and not the least, iPad and iPhone.
  • Reply 5 of 52
    This probably won't get a ton of attention compared with other Apple news but this stuff is HUGE.



    A hospital in Ottawa Canada where I grew up has ordered hundreds of iPads for doctors and nurses to facilitate new programs/apps that help with their jobs... This is the type of stuff that makes you realize how deep a penetration these devices are having.
  • Reply 6 of 52
    envirogenvirog Posts: 188member
    Cool!
  • Reply 7 of 52
    Wow...is it anything Apple can't do?
  • Reply 8 of 52
    quinneyquinney Posts: 2,528member
    Another knee to the groin for the "it's only a big iPod touch" crowd.
  • Reply 9 of 52
    Great news! This should be a big money maker for Apple and some developers.
  • Reply 10 of 52
    xzuxzu Posts: 139member
    Very well done. I can see more uses to come as the iPad's feature's increase. Apple is on the top of its game for sure.
  • Reply 11 of 52
    sflocalsflocal Posts: 5,990member
    Quote:
    Originally Posted by rcoleman1 View Post


    Wow...is it anything Apple can't do?



    Apple didn't "do" anything really. They just build high-quality, usable products that anyone can use and developers see the capabilities to capitalize on it.



    When the iPad came out and people were criticizing it for just being a big iPod Touch/iPhone, I immediately saw the iPad as a killer-product for the healthcare industry.



    It's going to be huge!
  • Reply 12 of 52
    mrstepmrstep Posts: 484member
    I'm stunned that a consumer-grade display is good enough for doing medical diagnosis work. I wonder if there's some funky display calibration that the software has built in to make sure everything in those images is displayed with a usable color balance / gamma / brightness.
  • Reply 13 of 52
    addaboxaddabox Posts: 12,665member
    Seems like the very things that some count as negatives for the iPad-- curated OS environment, stately pace of updates, very focused hardware choices-- are the things that make it attractive to corporate environments.



    Conversely, Android's "openness" may play well with a certain subset of consumers, but could be a barrier to entry in business environments, where endless proliferation of hardware, seemingly random OS updates per device, and the somewhat scurrilous vibe of the Android App Store probably aren't seen as huge wins.



    For instance, given the process of approving this app for medical diagnostics, how would you go about making a similar determination for "Android Tablets"? Is there even any way to define that, in the ways it would need to be defined for a specific application like this? And if not, if you would be obliged to try and certify "Medical Imaging for Xoom" (or whatever), would there be much point to that?



    It didn't matter, much, if PCs differed in trivial ways, because so much of how they operated was set in stone. Big monitor, small monitor, faster or slower CPU, more or less memory.



    Tablets are way more sensitive to the specifics of the implementations. A small screen makes it a different kind of device. Custom UIs make it a different kind of device. Resolution makes it a different kind of device.



    The iPad is one kind of device. In a few months, there will be a somewhat improved version of this device, but it will remain largely unchanged, in the ways that matter to user interaction. It's understandable that certain businesses are comfortable planning on iPads for their needs. It's not exactly clear to me if those same businesses would be comfortable planning on "Android Tablets", since that's likely to be a catchall phrase involving a number of different kinds of device.
  • Reply 14 of 52
    Cool. I have been waiting to hear more about hardware attachment since the equipment and API was demostrated 2 years(?) ago.



    I realize it's not as easy as programing an app for The Store. I hope there are more creative development to come.
  • Reply 15 of 52
    eulereuler Posts: 81member
    Everyone is congratulating Apple, but the App's developer deserves some "props" too.
  • Reply 16 of 52
    sflocalsflocal Posts: 5,990member
    Quote:
    Originally Posted by mrstep View Post


    I'm stunned that a consumer-grade display is good enough for doing medical diagnosis work. I wonder if there's some funky display calibration that the software has built in to make sure everything in those images is displayed with a usable color balance / gamma / brightness.



    I'll take Apple's version of "Consumer Grade" anytime over the cheap, plastic junk that the other vendors spew out.
  • Reply 17 of 52
    Quote:
    Originally Posted by addabox View Post


    Seems like the very things that some count as negatives for the iPad-- curated OS environment, stately pace of updates, very focused hardware choices-- are the things that make it attractive to corporate environments.



    Conversely, Android's "openness" may play well with a certain subset of consumers, but could be a barrier to entry in business environments, where endless proliferation of hardware, seemingly random OS updates per device, and the somewhat scurrilous vibe of the Android App Store probably aren't seen as huge wins.



    For instance, given the process of approving this app for medical diagnostics, how would you go about making a similar determination for "Android Tablets"? Is there even any way to define that, in the ways it would need to be defined for a specific application like this? And if not, if you would be obliged to try and certify "Medical Imaging for Xoom" (or whatever), would there be much point to that?



    It didn't matter, much, if PCs differed in trivial ways, because so much of how they operated was set in stone. Big monitor, small monitor, faster or slower CPU, more or less memory.



    Tablets are way more sensitive to the specifics of the implementations. A small screen makes it a different kind of device. Custom UIs make it a different kind of device. Resolution makes it a different kind of device.



    The iPad is one kind of device. In a few months, there will be a somewhat improved version of this device, but it will remain largely unchanged, in the ways that matter to user interaction. It's understandable that certain businesses are comfortable planning on iPads for their needs. It's not exactly clear to me if those same businesses would be comfortable planning on "Android Tablets", since that's likely to be a catchall phrase involving a number of different kinds of device.



    You hit the nail on the head.
  • Reply 18 of 52
    Quote:
    Originally Posted by anantksundaram View Post




    Kudos to the folks involved, the FDA, and not the least, iPad and iPhone.



    Quote:
    Originally Posted by euler View Post


    Everyone is congratulating Apple, but the App's developer deserves some "props" too.



    Excuse me?
  • Reply 19 of 52
    Just wait til you can "Bump" your iPhone or iPad with the doctor's device and transfer your records so you can keep them with you or have them transfer to a secure cloud-based storage environment.
  • Reply 20 of 52
    Quote:
    Originally Posted by mrstep View Post


    I'm stunned that a consumer-grade display is good enough for doing medical diagnosis work. I wonder if there's some funky display calibration that the software has built in to make sure everything in those images is displayed with a usable color balance / gamma / brightness.



    This is an example of an industry where a double-resolution display on the IPad would be a real win.
Sign In or Register to comment.