Posted on 02/05/2011 8:13:52 PM PST by Swordmaker
WASHINGTON -- The FDA has moved into the "got an app for that" market by approving the first diagnostic radiology application for the iPhone and the iPad.
In announcing the approval, the FDA said the application can be used to view results of CT, MRI, and PET scans on the mobile devices and use those images to make diagnoses.
But the agency noted that the app was "not intended to replace full workstations and is indicated for use only when there is no access to a workstation."
"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," said William Maisel, MD, MPH, chief scientist and deputy director for science in the FDA's Center for Devices and Radiological Health in a statement.
The new "device," which is designed for use with Apple products, is a software program called Mobile MIM, made by Cleveland's MIM Software.
The software allows radiology images taken in the hospital or physician's office to be "compressed for secure network transfer then sent to the appropriate portable wireless device," according to the FDA statement.
The images are then viewed on the iPhone or iPad in a format that "allows the physician to measure distance on the image and image intensity values and display measurement lines, annotations and regions of interest."
The FDA said it evaluated the app by testing its performance on a number of devices, measuring luminance, resolution, and noise against international standards and guidelines.
The FDA said it, "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."
In announcing the approval, the FDA noted that mobile devices have a wide range of variation in luminance even among the same model devices.
"The Mobile MIM application includes sufficient labeling and safety features to mitigate the risk of poor image display due to improper screen luminance or lighting conditions. The device includes an interactive contrast test in which a small part of the screen is a slightly different shade than the rest of the screen. If the physician can identify and tap this portion of the screen, then the lighting conditions are not interfering with the physician's ability to discern subtle differences in contrast," the FDA said.
MIM is including a safety guide within the application.
Nice for showing patients whats up at bedside or in your Docs office but I doubt many radiologists will be diagnosing by reading from their Ipad.
Not approved for high res imaging. But I agree with you that most radiologists will be reading from monitors that cost 10 times what an Ipad cost and are DICOM gray scale compliant.
The FDA also regulates medical devices.
No real surprise that Kodachrome was the first to go -- the process for it is seriously gnarly, and not shared by any other film, so it took a lot of infrastructure to process it. Your corner one-hour photo lab couldn't do a thing with it. Other films like Ektachrome are still in use.
News photographers were among the first to switch over. For them, fast, cheap and good enough trumps slow, expensive and perfect. The first event the AP shot in all digital was Super Bowl XXX, in 1996 (yes, I had to google that).
Glossy magazine covers were another matter. Depending on the film used, and how you define the comparison of analog grain to pixels, 35mm is roughly equivalent to 15-20 megapixels, a threshold that took digital cameras a while to reach.
Film is still useful for things like disposable cameras, but we're getting to the point where only artists will be interested in it.
That's an interesting and plausible theory... however, there are over twenty apps that do this already—ranging in price from free to over $400, some from top name companies—and radiologists are already doing it without FDA approval. . . just as they were doing it on Macs years ago prior to FDA bureaucratic approval.
The radiologists are perfectly capable of making a judgement as to whether the images are sufficiently clear or not to make the diagnosis. They read images far more often than do the desk bound bureaucrats who will determine whether to approve or disapprove the devices based on testimony from entrenched industry lobbyists and lunches and expense paid trips footed by eager new device/software developer lobbyists. It is, after all, the radiologists, who place their practices, reputations, and assets on the line when they make their diagnoses, risking mal-practice lawsuits if they misdiagnose the case, not the bureaucrat.
This app is nothing but hype. I guarantee you that NOT ONE radiologist will use this app for diagnostic work. Not one. I know.
>>This app is nothing but hype. I guarantee you that NOT ONE radiologist will use this app for diagnostic work. Not one. I know.<<
You may be right, but it is a good tool to be able to view diagnostic quality images so conveniently.
Then why would the FDA approve the application for diagnostic purposes?
We use very, VERY expensive high resolution monitors and graphics cards (for example, see this website that I just grabbed at random, MedicalDisplaysForLess.com, a title I found somewhat humorous...:) If you are reading mammography, you have to buy even higher resolution monitors, and two of them can run $15-20,000! I guess if you get them from MonitorsForLess, they might throw in free shipping, but I doubt it!
I am not a radiologist, and I don't play one in the movies either, so my eyes are not discriminating enough to see the difference unless the monitor calibration gets completely out of whack, but the radiologists can certainly tell, so it does make a difference to them.
To be honest, my specialty is not PACS (Picture Archiving and Communication System) I am responsible for the RIS (Radiology Information System) which the PACS is dependent on to get the information about the type of exam performed, who it is being performed on, who ordered the exam, when it should be done and so on.
Due to the way things are now, I find myself having to provide on-call support for PACS, and it is nerve-wracking to me, because it is not my specialty, and cross-training into it is not possible. I guess it would be like working your butt off as an orthopedic surgeon 70 hours a week, taking call, doing surgery and such, and deciding to become a neurosurgeon so you could cover for them when needed. (Okay, that is clearly an over-dramatization, but you get the idea)
But out of necessity and to maintain some level of sanity, I am trying like hell to learn that end of it on the fly. When the pager goes off at 0100 (as it did last night) and the problem is with the PACS, not the RIS, well...I am not ashamed to say it ratchets up the stress level in me by a factor of ten.
I really detest this aspect of the job. I have been working in medicine now for 26 years, the first 10 of them in clinical, now I am in informatics, and I have been on call the entire time. for at least ten out of those years, I was on call 24x7 every other week, and there were extended periods where I was the only one. I am notable in my group of acquaintances for having thrown my pager over a house at a party. When I was doing clinical, if I got paged, I was driving in to the hospital, no matter the time or the weather, and it was usually about a 2-3 hour interval before I got back home, and had to get up the next day and be at work. As clinical practices changed, and my specialty became more utilized by ER specialists, I began to get paged several times a night. It became so stressful for me that, if I was just listening to the radio or watching TV, and there was the sound of a pager in the movie or a commercial, I would flinch and literally jump.
At that point, I concluded I had to find a different line of work, it became too stressful for me, and at that point, I was fortunate enough to get in at the ground level as our hospital began the transition to digital radiology.
Now, if my pager goes off, it is still stressful, but not the same way. Granted, I cannot have my pagers (I am stupidly carrying three of them right now) set to make sound, because if I am sleeping and a pager goes off, I will literally levitate out of the bed. And that is not an exaggeration. My heart will race and pound, and it is extremely uncomfortable and a little scary. I set them all to vibrate, and keep them in a glass dish next to my bed. My heart still pounds when they vibrate, but...just a little bit.
And, hey. When I get paged, I put on my bathrobe, pad into my man-cave and turn my computer on, pick up the phone and call in. I can fix most things remotely, and the instances where I have to get dressed and jump in my car are rare indeed. This is FAR preferable to clinical call.
That said, it is a great job. With my sharing call with the PACS specialists, I am on backup call for one week (if the PACS guys get something they cannot figure out, they call me) then Primary call for a week, then two weeks off. Two weeks seems like luxury.
But most of all, the work is interesting, engaging, challenging and meaningful. I feel that what I do has a direct influence on the quality of care we give our patients, and...not everyone gets to say that in life. I'm lucky.
It is puzzling, I agree. bkopto is right, I don’t see it being used that way either. But, I am guessing the FDA is full of liberal political flunkies like every other agency, and the gee-whiz aspect of having approval for being able to diagnostically interpret studies from a small device in your pocket might have been way more important than actually being able to safely do it.
Hey, if a call is missed because it was interpreted primarily on an iPhone, the FDA won’t get sued, right?
I don’t know. I will be interested to hear what is said on Monday, because it will likely be the prime topic of discussion amongst some radiologists. I would not be surprised to see several messages on my phone when I get in. I guess that is good, radiologists who are engaged and constantly looking for ways to deliver service in a more timely fashion is an asset, but I know for a fact there are some who will be hit by the whizzy technical aspects of it, primarily...:)
LOL...here we go!
I think the difficulty on such a small device would be that you were zoomed in that much, and you pan the image in one direction...how do you know you didn’t pan a little to much and miss a quarter inch of the image...that quarter inch that shows the key point of fracture or whatever.
The iPad might be a good thing, though. This is fascinating, all the factors around this that one has to consider. I am interested to hear what the rads think of it.
On Monday. Tomorrow...:) Today is Super Bowl day!
LOL...it was a policy of ours to keep one lightbox on the wall next to each workstation. Now, we just use them for general illumination, such as when you drop your iPhone on the floor in the dark!
Radiology consists more than viewing images - there is reporting software which is tightly integrated with the image viewing software. This app has none of that integration - it is a viewer only. Besides, where are you gonna put the comparison images? You don’t have enough screen real estate. This app will be used MAYBE for quickly showing patients their exams at the bedside.
Again: NOT ONE radiologist will use this.
This app is for 2 main purposes.
One is consultations. Physician X sends an image to Physician Y across the country and asks for an opinion. This is done all of the time and apps like this just make it easier to do.
The second purpose is for when Patient Z comes in on an emergency basis to see Physician X who is away for 3 days attending a conference. Physician X asks his/her staff to send images ASAP. This is now being done more often in the last year.
Many docs have settled on the iPhone platform, so you seeing a ton of medical apps available across all specialties. Some of the apps are being created by large medical device companies who see the apps as a way to market and sell their imaging systems.
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