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FDA approves iPad, iPhone radiology app for mobile diagnoses

post #1 of 53
Thread Starter 
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 FDAs 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.

post #2 of 53
Helps make the iPhone and iPad more useful in the healthcare industry..
post #3 of 53
iPad is...radiological.
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post #4 of 53
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.
post #5 of 53
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.
post #6 of 53
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.
post #7 of 53
Cool!
post #8 of 53
Wow...is it anything Apple can't do?
post #9 of 53
Another knee to the groin for the "it's only a big iPod touch" crowd.
post #10 of 53
Great news! This should be a big money maker for Apple and some developers.
post #11 of 53
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.
post #12 of 53
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!
post #13 of 53
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.
post #14 of 53
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.
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post #15 of 53
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.
post #16 of 53
Everyone is congratulating Apple, but the App's developer deserves some "props" too.
post #17 of 53
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.
post #18 of 53
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.
post #19 of 53
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?
post #20 of 53
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.

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post #21 of 53
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.
post #22 of 53
The best is yet to come. Wait until the next iPhone comes with faster processor and bigger ram.

iPhone got its name just to get the public to buy into it. But the capability of the iPhone is beyond regular consumer. Phone call is less than 5% of what it is capable of doing.Many corporations are using iPhone in ways they don't want people to know because of business competition. The App Store is just like a fast food joint. Expensive cuisine is prepared for the rich and powerful, in hidden places. Surprisingly, one instrument makes everything possible. It is the magic of the iPhone.

And only Apple can invent such a genius and put it in ordinary person's reach.
post #23 of 53
I'd like to know by what right the FDA prevents the use of technological marvels (for several years) while countless people suffer and die in the interim.

Hooray! It only took a little more than a couple years to approve Mobile MIM! The FDA sure don't mess around! Kudos to it!

Such positive response to one of the most detestable bureaucracies makes me shiver.

Make no mistake: people are dying while they wait on the FDA to authorize their pursuit of happiness. The justification for the institution is as bogus as the war on drugs. The FDA does nothing that market forces, principled self-interest, and enforcement of existing fraud laws can't do and do more efficiently.

Nothing is guaranteed in this world and no one understands this better than the ill. It's a sick joke to use their protection as an excuse to prevent them and their doctors from exercising their own powers of thought and choice.

It is shameful.
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post #24 of 53
I work in a hospital and I had this same discussion with a co-worker today before I even heard of this story. Nurses, therapists, and doctors now have to walk around the hospital dragging a laptop suspended on a big cart or go to a work station. Our hospital is spending the money to put a work station in every patient room. I can't even imagine how much that is costing and it is taking years to implement. They could use iPads, give me a raise, and still significantly cut the cost of healthcare. I definitely see a day when everyone just carries a tablet (iPad or otherwise but hopefully iPad for the sake of my AAPL shares) and quickly and easily gets their documentation and ordering done. You can't imagine how many doctors already carry iPads around for quick reference of information. Most of them have iPhones also. In fact the first and only Samsung Galaxy tab I have seen was being carried by a doctor. This imaging software is just a start. I saw it when the iPad first came out and hoped Apple would get behind these kind of solutions. I am not one for catch phrases but in health care tablets are going to be game changers.

Brian
post #25 of 53
Quote:
Originally Posted by SpamSandwich View Post

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.

Why do you think Apple is putting in the near field chips that is all over the rumor mills? It isn't just for your credit card numbers.

Brian
post #26 of 53
Quote:
Originally Posted by sflocal View Post

I'll take Apple's version of "Consumer Grade" anytime over the cheap, plastic junk that the other vendors spew out.

Easy there! Without a doubt its better than the screens on other brands.

Now that we got that out of the way, I'm still surprised you don't need more than 8 bits per color channel (there are certainly 10 and 12 bit-per-channel displays out there) for this type of application + some decent color calibration, which certainly isn't accessible in the standard Settings in any case.
post #27 of 53
Quote:
Originally Posted by SpamSandwich View Post

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.

So many possibilities. Unlike the Samsung Nexus S I would expect NFC HW to accompany a usable app and probably an API for accessing the NFC.

For medical, a doctor could come in with their personal iPad and when they get near the passive chip in the wristband of the patient it sends the simple data of the patient’s ID to the device which then check the on-board databas or LAN database for chart info, which he can then look over and update as needed with text and/or audio. It would auto add his name and date without and inform him or a nurse immediately if a drug interaction or procedure was in conflict. Hospitals could service more people, faster, and with less incident thus saving more lives and risking less in malpractice… potentially.
post #28 of 53
Mobile access to positron scans is awesome.
post #29 of 53
Quote:
Originally Posted by mrstep View Post

Easy there! Without a doubt its better than the screens on other brands.

Now that we got that out of the way, I'm still surprised you don't need more than 8 bits per color channel (there are certainly 10 and 12 bit-per-channel displays out there) for this type of application + some decent color calibration, which certainly isn't accessible in the standard Settings in any case.

Interesting, but if you had a spectrum consisting of 255 shades of red, samples three or four apart would be indistinguishable, certainly for all intents and purposes, to the human eye wouldn't they?
post #30 of 53
Quote:
Originally Posted by anantksundaram View Post

Excuse me?

My point is that this is a story about an approval by the FDA of an app. Not FCC approval of the iPhone or iPad. Perhaps some are congratulating Apple for being to support such an app; I am trying draw the distinction between the hardware and the software.
post #31 of 53
Quote:
Originally Posted by sflocal View Post

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!

i hope they make an ad free version.
post #32 of 53
Agreed. Apple is on the high end of consumer grade. Further, if the iPhone is any indication of where the iPad screen quality is eventually going, the quality will soon be even more amazing.

Further, I suspect the original poster lacks understanding how medical images such as X-Rays are usually viewed and the iPad's potential. Not always, but generally X-Rays are not displayed on a computer screen. The film is essentially placed in a light table whereby the light illuminates the film. In such cases, the iPad is a better method for three reasons, 1) it is cheaper then the light tables, 2) the X-Ray can be manipulated easier to focus in on an area (think of the iPad's pinch and zoom features), and 3) the lightening on the iPad can be changed to suit the needs of the viewer.

Also, using an iPad allows people to view medial images such as the X-Rays sooner as they can be send to the device via Wi-FI as opposed to a Dr. having to wait for image or have to go to a see station to view it. In addition, the iPad has the potential to bring health care cost down.


Quote:
Originally Posted by sflocal View Post

I'll take Apple's version of "Consumer Grade" anytime over the cheap, plastic junk that the other vendors spew out.
post #33 of 53
It only take 1 app to be written and approved before everyone jumps on the bandwagon - and that is not a bad thing at all. Showing a patient their scan on an iPhone or iPad is a quantum leap for all.
post #34 of 53
Quote:
Originally Posted by euler View Post

My point is that this is a story about an approval by the FDA of an app. Not FCC approval of the iPhone or iPad. Perhaps some are congratulating Apple for being to support such an app; I am trying draw the distinction between the hardware and the software.

Without the hardware, there would be no software. And without the software there would be no FDA.

If that's not obvious, I don't know what to say....
post #35 of 53
You are probably generally right. Sometimes, however, Apple actually does lend particular developer's hands on support. Take for instance Apple recently supporting Cherokee as a language on iOs devices. Apple will often times change APIs and its developer tools if an important developer needs changes.

Quote:
Originally Posted by sflocal View Post

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!
post #36 of 53
Quote:
Originally Posted by WIJG View Post

I'd like to know by what right the FDA prevents the use of technological marvels (for several years) while countless people suffer and die in the interim.

Hooray! It only took a little more than a couple years to approve Mobile MIM! The FDA sure don't mess around! Kudos to it!

Such positive response to one of the most detestable bureaucracies makes me shiver.

Make no mistake: people are dying while they wait on the FDA to authorize their pursuit of happiness. The justification for the institution is as bogus as the war on drugs. The FDA does nothing that market forces, principled self-interest, and enforcement of existing fraud laws can't do and do more efficiently.

Nothing is guaranteed in this world and no one understands this better than the ill. It's a sick joke to use their protection as an excuse to prevent them and their doctors from exercising their own powers of thought and choice.

It is shameful.

With all due respect, you'll be the first person to sue the FDA if goes terribly wrong, making the argument for something having been rushed to market.
post #37 of 53
Quote:
Originally Posted by anantksundaram View Post

Without the hardware, there would be no software. And without the software there would be no FDA.

If that's not obvious, I don't know what to say....

I can appreciate the symbiotic relationship between software and hardware. I am "sure" that app developers will be congratulated just as vociferously when the iPad2 comes out.

My point was through my original comment there had been 20 mentions of Apple/iPhone/iPod. 0 for MIM (excluding your reference to "the folks involved").

Can you expand on your comment that "without the software there would be no FDA.". This is not obvious to me. The FDA has been around for much longer than software has.
post #38 of 53
Quote:
Originally Posted by WIJG View Post

I'd like to know by what right the FDA prevents the use of technological marvels (for several years) while countless people suffer and die in the interim.

Hooray! It only took a little more than a couple years to approve Mobile MIM! The FDA sure don't mess around! Kudos to it!

Such positive response to one of the most detestable bureaucracies makes me shiver.

Make no mistake: people are dying while they wait on the FDA to authorize their pursuit of happiness. The justification for the institution is as bogus as the war on drugs. The FDA does nothing that market forces, principled self-interest, and enforcement of existing fraud laws can't do and do more efficiently.

Nothing is guaranteed in this world and no one understands this better than the ill. It's a sick joke to use their protection as an excuse to prevent them and their doctors from exercising their own powers of thought and choice.

It is shameful.

If you don't know where the FDA gets its mandates from; or how it works, you shouldn't be making hyperbolic statements.

Market forces gave us the housing bubble, the internet bubble, the Great Depression, pollution. The diagnosis on market forces are not good. Principled self-interest is an oxymoron. Like James Madison said, "If men were angels, no government would be necessary. "
post #39 of 53
Quote:
Originally Posted by euler View Post


Can you expand on your comment that "without the software there would be no FDA.". This is not obvious to me. The FDA has been around for much longer than software has.

It's obvious when you read things in context.

(I.e., I was referring to this app, not 'software' in general or the 'FDA' in general.)
post #40 of 53
Quote:
Originally Posted by pembroke View Post

Interesting, but if you had a spectrum consisting of 255 shades of red, samples three or four apart would be indistinguishable, certainly for all intents and purposes, to the human eye wouldn't they?

No, it's definitely not indistinguishable depending on the width of the band or color. Assuming a reasonably well calibrated monitor, you can certainly see banding in some 24-bit color images on similar-color-gradients (and I just did a quick 4 band image with red varied by just 1 level between each section as a double-check in PS, and yes, you can see the bands). 3-4 steps apart would be very apparent.

You can see the difference when rendering to 16 bits per channel vs 8 bits per channel on certain types of output (sometimes you'll do a 16-bit per channel and then dither it down to 24 or 16 bit color to avoid seeing banding), but again, maybe this medical software lets you select ranges in the original images to 'expand' across the 256 levels to enhance visibility (no need to try and just preserve the original xray or whatever - it's a computer, so let it enhance it, right?). Or maybe the originals are only 8 bits per color anyway. Or they dither it. Or... maybe it's just good enough for these images, even if you'd work with more depth for some graphics work.
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