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FDA approves iPad, iPhone radiology app for mobile diagnoses - Page 2

post #41 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.

The FDA may have approved this but doctors can choose any method they like to diagnose conditions. It is more about malpractice insurance. We've been examining X-rays over the Internet for years.

So about the screen. When taking X-ray you want to minimize the dosage so you never want to capture a larger image than you need. The latest high tech X-rays are digital, no film. 3D digital imaging allows for detailed analysis from multiple views and slices. The largest high resolution X-ray we have is 170 mm x 170 mm at 80 micrometer resolution. That is roughly 7" x 7" at 300 dpi for those using the Imperial system. So as you can see, if a doctor wanted to zoom in and pan around, the iPad would allow viewing the image at a greater magnification than the resolution of the captured data. As far as the image detail is concerned, the original captured data is only 13 bit grayscale so again the iPad has much greater color gamut than needed for this type of work.

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post #42 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.

Your comments prove that you have no understanding of why the FDA was created to begin with.
Artificial intelligence is no match for natural stupidity.

"A common mistake that people make when trying to design something completely foolproof is to underestimate the ingenuity of complete fools."
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Artificial intelligence is no match for natural stupidity.

"A common mistake that people make when trying to design something completely foolproof is to underestimate the ingenuity of complete fools."
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post #43 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.

There is actually real science proving that consumer grade stuff is sufficient. Here is the abstract of a study we did a few years ago to assess whether or not one has to buy $12,000 (at the time) medical grade monitors.
I am NOT surprised that the iPad is good enough, display technology has improved, and the iPad display is really quite high quality.

ROC study of four LCD displays under typical medical center lighting conditions.

J Digit Imaging. 2006 Mar;19(1):30-40.
Langer S, Fetterly K, Mandrekar J, Harmsen S, Bartholmai B, Patton C, Bishop A, McCannel C.

Mayo Clinic and Foundation, Department of Radiology, 200 First Street SW, Rochester, MN 55905, USA. langer.steve@mayo.edu
Abstract
Nine observers reviewed a previously assembled library of 320 chest computed radiography (CR) images. Observers participated in four sessions, reading a different 1/4 of the sample on each of four liquid crystal displays: a 2-megapixel (MP) consumer color display, a 2-MP business color display, a 2-MP medical-grade gray display, and a 3-MP gray display. Each display was calibrated according to the DICOM Part 14 standard. The viewing application required observer log-in, then randomized the order of the subsample seen on the display, and timed the responses of the observer to render a 1-5 judgment on the absence or presence of ILD on chest CRs. Selections of 1-2 were considered negative, 3 was indeterminate, and 4-5 were positive. The order of viewing sessions was also randomized for each observer. The experiment was conducted under controlled lighting, temperature, and sound conditions to mimic conditions typically found in a patient examination room. Lighting was indirect, and illuminance at the display face was 195 +/- 8% lux and was monitored over the course of the experiment. The average observer sensitivity for the 2 MP color consumer, 2 MP business color, 2 MP gray, and 3 MP gray displays were 83.7%, 84.1%, 85.5%, and 86.7%, respectively. The only pairwise significant difference was between the 2-MP consumer color and the 2-MP gray (P = 0.05). Effect of order within a session was not significant (P = 0.21): period 1 (84.3%), period 2 (86.2%), period 3 (85.4%), period 4 (84.1%). Observer specificity for the various displays was not statistically significant (P = 0.21). Finally, a timing analysis showed no significant difference between the displays for the user group (P = 0.13), ranging from 5.3 s (2 MP color business) to 5.9 s (3 MP Gray). There was, however, a reduction in time over the study that was significant (P < 0.001) for all users; the group average decreased from 6.5 to 4.7 s per image. Physical measurements of the resolution, contrast, and noise properties of the displays were acquired. Most notably, the noise of the displays varied by 3.5x between the lowest and highest noise displays. Differences in display noise were indicative of observer performance. However, the large difference in the magnitude of the noise was not predictive of the small difference (3%) in the observer sensitivity for various displays. This is likely because detection of interstitial lung disease is limited by "anatomical noise" rather than display or x-ray image noise.

PMID: 16249836 [PubMed - indexed for MEDLINE]
post #44 of 53
Quote:
Originally Posted by applestockholder View Post

There is actually real science proving that consumer grade stuff is sufficient. Here is the abstract of a study we did a few years ago to assess whether or not one has to buy $12,000 (at the time) medical grade monitors.
I am NOT surprised that the iPad is good enough, display technology has improved, and the iPad display is really quite high quality.

ROC study of four LCD displays under typical medical center lighting conditions.

J Digit Imaging. 2006 Mar;19(1):30-40.
Langer S, Fetterly K, Mandrekar J, Harmsen S, Bartholmai B, Patton C, Bishop A, McCannel C.

Mayo Clinic and Foundation, Department of Radiology, 200 First Street SW, Rochester, MN 55905, USA. langer.steve@mayo.edu
Abstract........

PMID: 16249836 [PubMed - indexed for MEDLINE]

This is one thing I'm not sure about, people don't realize that medical equipment/drugs is often a total scam, there's little way to tell if something is worth its price, and it usually is not. The price paid is negotiated by government bureaucrats, and is usually exorbitantly higher than is needed for R&D and manufacturing costs. There are very little free market forces in medicine (I don't see why giving these same a-holes more power is going to make things better). Anyway, I'm not sure how apple is going to play this game, they could save hospitals TONS of money, not to mention lives, by going to apple and paying consumer prices for superior products, but apple would have to get its hands pretty dirty unfortunately. But, maybe they can invade the system like they're invading enterprise IT departments, from the ground up. I'm keeping my fingers crossed, and I'm going to be implementing apple into my future practice as much as possible (although as a psychiatrist I won't be nearly as encumbered by hospital or government administrators as most of my other my colleagues).

One example: Medicare part D (prescription coverage) is an indisputable scam. Instead of the gov buying in bulk for medicare and getting a discount as is logical, the new law PREVENTS government from negotiating prices with the drug companies. I'm not being hyperbolic when I say that the legislators in charge should be put in prison. Just after the law's passing, the legislator in charge of it took a job working as a lobbyist for the drug companies making $2 million a year (there are multiple other similar examples).

Anybody who is not aware of this, or who has not experienced the wonders of working at a county hospital should not be deciding how much power to give the government and how much to extend the scope of care. I guarantee you these things are not on Obama's mind; he's more concerned about creating a his 'legacy' of healthcare, "for all", than doing the right thing(s).
post #45 of 53
Quote:
Originally Posted by quinney View Post

Another knee to the groin for the "it's only a big iPod touch" crowd.

It is due to the hardware and software validation. If this was written for Android they would need to validate for every platform or only support specified devices. Even here each new iPad iteration would require re validation. So when iPad 2 comes out there will be a delay before that hardware is supported. I would also imagine thhat each iOS update will require some validation work.

I understand the big iPod Touch thing but I've also worked in the medical industry for years and what happens to keep the FDA happy is at times mind boggling. Validation work is demanding, detailed to the extreme and requires deep understanding of the laws rules and regulations. The fact that the iPod is a well defined piece of hardware likely had a lot to do with making approval happen.
post #46 of 53
In fact i would suggest that one of the issues the developers talked about is how to display that dynamic range on an iPad. Especially on a LCD sceen where dynamic range never has been all that great. It is great that they have gotten approval, but we must note that approval is limited in scope and does not eliminate the need for a dedicated workstation monitor.

Quote:
Originally Posted by mstone View Post

The FDA may have approved this but doctors can choose any method they like to diagnose conditions. It is more about malpractice insurance. We've been examining X-rays over the Internet for years.

So about the screen. When taking X-ray you want to minimize the dosage so you never want to capture a larger image than you need. The latest high tech X-rays are digital, no film. 3D digital imaging allows for detailed analysis from multiple views and slices. The largest high resolution X-ray we have is 170 mm x 170 mm at 80 micrometer resolution. That is roughly 7" x 7" at 300 dpi for those using the Imperial system. So as you can see, if a doctor wanted to zoom in and pan around, the iPad would allow viewing the image at a greater magnification than the resolution of the captured data. As far as the image detail is concerned, the original captured data is only 13 bit grayscale so again the iPad has much greater color gamut than needed for this type of work.
post #47 of 53
My Doctor uses since last six months to order medical prescription.
No more papers.It goes straight to pharmacy via internet.
post #48 of 53
Quote:
Originally Posted by wizard69 View Post

In fact i would suggest that one of the issues the developers talked about is how to display that dynamic range on an iPad. Especially on a LCD sceen where dynamic range never has been all that great. It is great that they have gotten approval, but we must note that approval is limited in scope and does not eliminate the need for a dedicated workstation monitor.

No image makes it to workstation or iPad without being converted to 8 bit grayscale tiff. Most of the time film scanned to digital has already degraded to a degree that the examiner needs to adjust the contrast histogram to try to reveal the crucial information that is not immediately obvious. There is an art to analysing X-rays that has less to do with resolution and gamut and more to do with experience.

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post #49 of 53
The more important aspect of this article is the fact that iPad has made its way into the back office part of storing and distributing medical information. The total office management of patient records and treatment planning has been entirely windows up until this point.

Life is too short to drink bad coffee.

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post #50 of 53
I'm not a radiology research (anymore). but it's not a scam. We did double blind testing on visualization devices, and a 'perfect' replicate of an XRay to the eyes of a Practicing Radiologist is 12bits grey and 4096 dpi. To get the software on the iPad to meet FDA requirements [likely lower for 'non-diagnostic use' (ie: something a surgeon can look at prior to operating)], while less rigorous, is non-trivial.

The key issue with computers in today's medical practice is that MD's Move around the office... often working in 20-30 rooms in one day. Couple in patient privacy and authentication demands, having a portable device like an iPad (I was looking at windoze tablets in 1994) is a major breakthrough, as it completely changes the IT requirements for a MD. Tthe most simple example... a Doctor never wants to see bad news in front of a patient.... and that requires a workstation outisde the door of every exam room, and one in the exam room (for placing orders... you've just reduced 4 workstations per MD (office, exam room, diagnostic room , and hallway)... to 2 (desktop and portable), while improving his workflow (remember, to a clinic, the critical billing path is 'Dr Visits per hour'... if you can get 4 in, instead of 3, by just eliminating authentication in and out of all the systems she must use... you've reduced the fixed cost of MD (200K fam practice MD) care from $33/visit to $25/visit [26%], while improving patient privacy, and lowering HW costs as well. Serious Savings.
post #51 of 53
Quote:
Originally Posted by mstone View Post

No image makes it to workstation or iPad without being converted to 8 bit grayscale tiff. Most of the time film scanned to digital has already degraded to a degree that the examiner needs to adjust the contrast histogram to try to reveal the crucial information that is not immediately obvious. There is an art to analysing X-rays that has less to do with resolution and gamut and more to do with experience.


agreed. Trained Radiologists 'see' 12 Bit Grey at 4096 DPI (our double blind was not quite that much, back in 1990's). Hence most 'online views' are considered 'non-diagnostic' (for use by surgeons or to display to patients prior to procedures). Diagnostic Radiologists will still prefer high(est) resolution displays costing $5000 or so.
post #52 of 53
Quote:
Originally Posted by hiphilly View Post

My Doctor uses since last six months to order medical prescription.
No more papers.It goes straight to pharmacy via internet.

probably in clear text ;-)
post #53 of 53
Quote:
Originally Posted by TheOtherGeoff View Post

I'm not a radiology research (anymore). but it's not a scam. We did double blind testing on visualization devices, and a 'perfect' replicate of an XRay to the eyes of a Practicing Radiologist is 12bits grey and 4096 dpi. To get the software on the iPad to meet FDA requirements [likely lower for 'non-diagnostic use' (ie: something a surgeon can look at prior to operating)], while less rigorous, is non-trivial.

The key issue with computers in today's medical practice is that MD's Move around the office... often working in 20-30 rooms in one day. Couple in patient privacy and authentication demands, having a portable device like an iPad (I was looking at windoze tablets in 1994) is a major breakthrough, as it completely changes the IT requirements for a MD. Tthe most simple example... a Doctor never wants to see bad news in front of a patient.... and that requires a workstation outisde the door of every exam room, and one in the exam room (for placing orders... you've just reduced 4 workstations per MD (office, exam room, diagnostic room , and hallway)... to 2 (desktop and portable), while improving his workflow (remember, to a clinic, the critical billing path is 'Dr Visits per hour'... if you can get 4 in, instead of 3, by just eliminating authentication in and out of all the systems she must use... you've reduced the fixed cost of MD (200K fam practice MD) care from $33/visit to $25/visit [26%], while improving patient privacy, and lowering HW costs as well. Serious Savings.

All excellent points.

Proud AAPL stock owner.

 

GOA

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Proud AAPL stock owner.

 

GOA

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