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.
I bet that's not the only thing it's used for.
The app allows viewing of scans taken by other devices by transmitting them to an iPhone or iPad, it doesn’t create them itself, BigSkyFreeper.
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It wasn’t all that long ago when docs were saying that films would never be replaced with digital images.
That must been the General Practitioners that said that....
I never said the app creates them.
But hey...I could be wrong.
"...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."..."
That seems like a hole big enough to drive a truck through. I find it hard to imagine any responsible radiologist doing a diagnostic interpretation on a cervical spine fracture xray from viewing it on an iPhone. I suppose if you are desperate, then sure, you do what you can.
At the very least, they will love it for the consultation potential. I am sure my team will hear about this on Monday morning, first thing...:)
No. Radiologists.
I had a discussion with someone who worked at a hospital that was at the vanguard of the transition to digital imaging.
There was so much resistance, that they took a piece of film, cut out the center of the film and attached it to a monitor on a workstation, so the radiologist could reach up and grab a reassuring piece of film between their fingers while they viewed the digital images.
I think they were joking.
Maybe.
IF the image is of sufficient resolution, then I don’t see why it could not be used as such - it would just take a bit longer with zooming in and looking at each individual area closely.
Most of them would never, ever go back now. Speech recognition, however, is a completely different ball of wax...:)
We have been using it for about six or seven years, now, and there are some who bitch daily about it. They would jettison that in a heartbeat.
Agreed, but...it really does seem like a stretch, when you consider the monitor calibration hassles and record keeping that one is mandated to go through on diagnostic workstations.
It just seems...er...odd.
Orthopaedists routinely consult ER docs by remotely viewing images on laptops/pc’s. Now the technology is pocket sized.
Resolution was certainly one factor, but the bigger factor was the gray scale on CRT monitors. 8-bit grayscale (256 levels) was not sufficient.
True...but a consultation is a much different beast than a diagnostic read.
Heck, people used to put images in email and such for consultation purposes.
Even still, every tool that can give clinicians a little more flexibility is a good thing. Makes our job harder, having to support this kind of thing, but if it is for improving patient care, then...it’s all good...:)
Nah, you are a Freeper! Freepers are never wrong ..... unless I disagree with them. :-)
I still keep one film viewer in the lab, but we recently threw away the last of the ones we still had in storage at the clinic.
What kind of displays are used on current workstations? The iPhone has excellent color fidelity and gamut. Or is it an issue of screen size? Do the workstations have hoods and hardware calibration? (I don't know much about radiology, but in another life I worked in print production on CRT monitors, so I know a bit about display calibration). I find it hard to imagine any responsible radiologist doing a diagnostic interpretation on a cervical spine fracture xray from viewing it on an iPhone. I suppose if you are desperate, then sure, you do what you can. At the very least, they will love it for the consultation potential. I am sure my team will hear about this on Monday morning, first thing...:)
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