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No...not in my opinion...i only wanted to post it because some were under the impression a week or so ago that this meeting had something to do with us... i just wanted to share what came of it, what its purpose was...at a little more insight level than i could give earlier...
the only parallels seem to be the longevity...
moreover, we are not a class III issue, we are class II.
and CAD is not applicable to the DViS...
FDA takes baby steps in reclassifying FFDM, CAD systems
By Kate Madden Yee
AuntMinnie.com staff writer
November 23, 2009
Waiting for change from the U.S. Food and Drug Administration (FDA) often requires the patience of Job. Vendors of full-field digital mammography (FFDM) and computer-aided detection (CAD) products are learning this firsthand, as the agency slowly moves toward easing its regulatory approval process for the technologies.
The FDA's Radiological Devices Panel of the Medical Devices Advisory Committee held a meeting last week as the latest step in a review process that initially began in 2006, when the agency said it was considering relaxing the requirements for FFDM products by reclassifying them from class III devices to class II. At the meeting, the panel hinted that it might have final rules ready a year from now -- a date that many industry watchers believe is unreasonable for a review process now entering its fourth year.
During the two-day meeting on November 17 and 18, the panel clarified a few points of a May 2008 draft guidance on FFDM regulation and also tackled the issue of reclassifying CAD systems, for which a draft guidance was issued in October.
While some industry representatives have been frustrated at the agency's slow pace, some feel the fact that the panel meeting was held at all is a good sign.
"[Last week's] meetings were a very positive step in the process of clarifying the regulatory requirements for FFDM and CAD. FDA should be congratulated for holding this meeting," said Stephen Vastagh, director of international and industry programs at the Medical Imaging and Technology Alliance (MITA) in Arlington, VA.
Industry to FDA: Make FFDM clearance less burdensome
The Radiological Devices Panel consists of radiologists, medical physicists, biostatisticians, and other experts who provide advice and guidance to the FDA. Although they can help guide FDA policy, their suggestions are not binding for the agency.
At the meeting, the panel heard from mammography developers as well as academic researchers who lobbied for a less burdensome process to obtain clearance for FFDM devices, according to an FDA summary of the meeting.
"The regulatory requirements for FFDM device clearance have been excessive," said Vastagh. "The message the panel received was that the requirements should be commensurate with the amount of changes that are made in new products under the 510(k) process."
Although originally novel technologies, both FFDM and CAD have become well-established and are part of the routine standard of breast care. The first FFDM system was approved in 2000, and the FDA in May said that FFDM units make up more than 50% of the installed base of mammography systems.
Likewise, the first commercial CAD application was approved in 1998 for breast imaging -- since then, the technology has blossomed into dozens of new clinical applications.
A key issue with the current regulatory pathway for FFDM is the burden of showing the technology's equivalency to analog mammography via clinical trials, as required by the premarket approval (PMA) process, according to Dr. Etta Pisano of the University of North Carolina at Chapel Hill School of Medicine and lead investigator for the Digital Mammographic Imaging Screening Trial (DMIST). Pisano spoke at the panel meeting.
"We know how digital performs relative to film-screen," she told AuntMinnie.com. "We've already double-exposed over 50,000 women for the DMIST trial, and we don't need to do that anymore. It's unethical for FDA to require double exposure of women when we already have so much data on digital mammography. There's just no reason for companies to have to present that same kind of extensive clinical data when DMIST used the same machines."
Specific concerns voiced by the panel about digital mammography were focused on its use as a diagnostic tool. The panel emphasized that because diagnostic mammography includes additional views compared to screening mammography, it should require additional evaluation in a 510(k) process.
But the panel recommended that the FDA take a graduated approach to premarket requirements, noting that DMIST has shown that FFDM is as effective as film-screen mammography and has comparable radiation dose, and that the physical characteristics of the current FFDM devices on the market are well understood, according to the statement.
"The panel advised that for new submissions having comparable technological characteristics when compared to the predicate device, physical laboratory testing with small samples of clinical images is sufficient to show substantial evidence," the FDA wrote.
Is this forward movement? Some attendees weren't sure.
"At the end of the day, the FDA affirmed the same concept [as it did in the 2008 draft guidance]: 'Yes, we want to make FFDM class II instead of class III,' " said James Culley, Ph.D., director of marketing for women's imaging vendor Hologic of Bedford, MA. "The question [the agency still has] is whether to have special requirements for diagnostic FFDM versus screening."
When will the final guidance be published? At the meeting the FDA mentioned fall 2010, according to Vastagh.
"Issuing the final guidance next fall is way too far out," he said. "There isn't anything else to do except take the comments from this meeting and rewrite the documents. The agency isn't starting with a blank page. We hope that by the fourth anniversary of the first hearing [on this issue], in May of next year, the final guidance will be posted."
Four companies sell FFDM units in the U.S. and 12 companies sell units in Europe and elsewhere, Vastagh said. After this much delay, it would be shameful to further hold up the products already in the pipeline.
"This horse is beaten to death," Vastagh said.
Concerns about CAD
After the discussion of FFDM, the panel shifted its direction to discuss its regulation of computer-aided detection technology, according to Julian Marshall, director of R2 product management and principal engineer at Hologic.
"At prior meetings on CAD, there was a lot of emphasis on vendors doing clinical testing," Marshall said. "This time the panel came out in favor of correctly done standalone testing. This is a distinct improvement because in the previous guidance document, the FDA put in a requirement that test datasets could be used only once, meaning that every time a vendor wanted to test the equipment again, it would have to put together another database."
CAD's regulatory process is in a similar place as FFDM was in May 2008, Vastagh said.
"We are hopeful that there will be a similar discussion for CAD about clinical studies being commensurate with the risk level of the device," he said.
By Kate Madden Yee
AuntMinnie.com staff writer
November 23, 2009
sonomawest re: detector plate concept...
http://www.healthcare.philips.com/main/products/ct/products/ct_brilliance_ict/animations.wpd
this page has three really good three one-minute-long animations of a the working aspects of a CT scanner...
1st animation -- airglide technology.
2nd animation -- the x-ray tube.
***3rd animation -- the detector plate.
hi sonoma...there are a lot of similarities between photograph and radiography...
here's some points on your question...generally speaking first.
there are geometric properties...meaning that if the object to image receptor distance (OID) is great (subjective), then the object will be magnified. it's like how a shadow works on the wall with a flashlight. meaning the closer your hand gets to the flashlight the bigger your hand's shadow looks on the wall.
in fluoroscopy (dynamic: conventional c-arm) we have another option, not available in radiography (static), and that's electronic magnification...
when x-rays leave the tube and go through the body and then strike the image receptor - they turn into light photons, the light photons then turn into electrons (and because only electrons have a charge compared to the x-ray and the light photons), the electronics are then focused to the output screen (and intensified with focusing) --- this is called flux gain --- i always thing of Doc Brown. however, if the focal point (or criss cross) is further away from the output screen, say in mag 1 or mag 2...done by increasing the negativity inside the eye to repel the electrons (like charges repel) and cause them to travel more grouped-together through the I.I., then the image is magnified... the whole process is similar to how the eye works and is why in traditional c-arm fluoro - the image intensifier (receptor) is called (I.I.) or simply the "I," i.e., the eye.
in addition, today's digital processes, in static radiography for example, permit zoom on the monitor by simply clicking and dragging your mouse around the area you want to zoom in on... let's say a radiologist wants to look more closely at something on a chest x-ray...well, on some software packages, they can just zoom in on it without loosing detail.
this would be similar in CT and MRI "screen shots."
as far as the detector size that the DViS uses, by looking at the videos which i'm sure you've watched where dean is near the prototype gantry and the tube/detector plate are revolving...you can sorta get an idea...but i memory serves i think it's always spinning to fast if you don't know what you're looking for/at.
here's a youtube vid...
service contracts...fluoroscopy
include what in the field is refered to simply as an annual PM (i.e., preventative maintenance)...when performed by the manufacturer...
not company related:
the medical physicist also does what is called, physics acceptance testing...to ensure standards are met... this battery of tests includes high contrast / low contrast imagery.
some fluoro machines are done biannually...
by the way, these all above steps ensure that ***Federal and state rules/regulations*** are met.
the same applies to CT...
thus, my reasoning for the high contrast / low contrast images requested by the FDA and sent accordingly by IMGG, that they (the FDA) are taking the CT aspect of the DViS seriously.
it's a QA (quality assurance) thing...
cheers...
hi SJF in a follow up to your comments/questions...
per filing: page 50
Direct Competitors
At this time, we are not aware of any existing devices in the marketplace that provide 3D, real-time diagnostic medical imaging, with the exception of ultrasound equipment by several manufacturers.
Ultrasound is a real-time tomographic imaging modality. Not only does it produce real-time tomograms of the position of reflecting surfaces (internal organs and structures), but also it can be used to produce real-time images of tissue and blood motion. However, ultrasound is a low-resolution imaging modality that does not produce an image as precise and clear as fluoroscopy. Our devices will rely instead on the use of fluoroscopy, a high-resolution imaging modality, to produce "live" X-ray images of a living patients in 3D.
http://sec.edgar-online.com/imaging3-inc/sb-2a-securities-registration-small-business/2005/04/18/Section15.aspx
hey somomawest re: pixel matrix/monitor: as a follow-up to my earlier post in reply to you:
pages 40 and 41:
Real time 3D imaging will require a state-of-the-art computer system with customized software. The computer will be outfitted with customized image processing boards to capture and compute images at lK x lK resolution at 30 to 60 frames per second. The combination of software and hardware will process the image data to create a 3D image map. This map will then be displayed to the physician. The physician will be required to enter reference data to start real time imaging. Once the physician enters the data (most of which is choosing which direction and portion of the body he/she would like to work with), the O-device will be positioned and the image will be updated with any new information, as added by the physician controlling the X-ray generation. Our Technology creates an image map with three dimensions and will update that map with new information, without having to create a new image.
1K x 1K resolution is a term, which is used in many industries to define a pixel matrix of an image. The term is broadly used throughout many industries and is defined as one thousand vertical lines by one thousand horizontal pixels. In the simplest of terms, if a person were to draw one thousand lines on a piece of paper from the top to the bottom starting from the left side of the paper to the right side of the paper, then draw one thousand lines horizontally from left to right, from the top of the paper to the bottom. Where each line intersects there would be a dot, which would represent a pixel. Counting each of these dots, one would find one thousand dots per every line in any direction horizontally or vertically. This drawing represents a matrix. Most
40
--------------------------------------------------------------------------------
devices however use a pixel matrix of 1024 vertical lines by 1024 horizontal pixels. Lay persons in most industries commonly refer to this as 1K x 1K for ease of reference, it is also commonly referred to as 1 mega pixel matrix or 1 million-pixel matrix: one thousand times one thousand equals one million.
http://sec.edgar-online.com/imaging3-inc/sb-2a-securities-registration-small-business/2005/04/18/Section15.aspx
OEC's workstation monitors are for most models out there, 1000 x 1000. on the 9800, for example, the left monitor is this, the right monitor doesn't have the same resolution...the last image remains on the left monitor, and you can flip last images back and forth between the left/right monitors to compare the next image to the prior image on the right, for example. the left monitor is the one you watch under live or single image imaging. new flat panels look nice all the way around.
some say that the pictures from the Philips' c-arms look a little prettier though, don't know if it is related to the monitor only though, don't think it is. Philips is or is becoming biggest c-arm name after OEC.
hey joe... it's all good... i watch for posts where i can provide informative information... such as my post #4984 on "quantum mottle" to the rascal inquiring about grainy pictures...post #4978 -- i'd like to know where he heard his concern about realtime clarity... maybe he took the prior QA picture request the wrong way... but that request had nothing (as we understand it) to do with the real-time feature...
as you can appreciate all my posts are based on my educated understanding...i don't have much to add til i hear the interview tomorrow. however, i think that it's likely the IMGG-start to ramping up for RSNA.
dean stated in his last cc/or on the last interview, he wanted to provide updates prior to or during RSNA (but that the later would be worked out as they went along -- as i paraphrase -- sorta played by ear). i imagine he's got a pretty tight schedule right now...
i've been trying to dig up some good RSNA stuff from the auntminnie website just for some entertainment but so far haven't really found anything applicable.
by the way, i crack up hearing from some of those yahooligan scare artists... as far as i'm concerned if someone is long common shares then we're all in this together...
i seriously ROTFLMAO at carmin3d looking up the internet information on dear ole auntminnie.
an fda advisory committe met yesterday and today to talk about mammo and CAD...those things aren't related to the DViS...
hi, i'm getting ready for a procedure here and don't have time to go into it right now... maybe you can read some of my posts on the QA images (high contrast / low contrast) for CT... it's par for the course to obtain such data during physics acceptance testing done either annually or biannually for both fluoro and CT.
sometimes pulsed fluoro can be somewhat grainy, it's called "quantum mottle," it depends on patient thickness usually, however, we perform all our procedures in pulsed mode with an OEC c-arm... diagnostic images require better contrast...
however, pulsed fluoroscopy can also provide very clear images, again depends on patient thickness... the machine typically adjusts milliamperage to compensate...
long story short, likely not an issue at all...imho and per my dd and experience.
i refer you to please read about pulsed fluoroscopy:
http://radiographics.rsna.org/content/21/4/1033.full.pdf
The AAPM/RSNA Physics
Tutorial for Residents
Fluoroscopy: Patient Radiation
Mahadevappa Mahesh, PhD
Fluoroscopic procedures (particularly prolonged interventional procedures) may involve high patient radiation doses. The radiation dose depends on the type of examination, the patient size, the equipment, the technique, and many other factors. The performance of the fluoroscopy system with respect to radiation dose is best characterized by the receptor entrance exposure and skin entrance exposure rates, which should be assessed at regular intervals. Management of patient exposure involves not only measurement of these rates but also clinical monitoring of patient doses. Direct monitoring of patient skin doses during procedures is highly desirable, but current methods still have serious limitations. Skin doses may be reduced by using intermittent exposures, grid removal, last image hold, dose spreading, beam filtration, pulsed fluoroscopy, and other dose reduction techniques. Proper training of fluoroscopic operators, understanding the factors that influence radiation dose, and use of various dose reduction techniques may allow effective management of patient dose.
hi, not directed to me, but if i may interject, the DViS represents the next generation in fluoroscopic guided procedures/surgery.
the medtronic's o-arm does not do realtime 3d imaging.
dominion - what it is...
the DViS provides 16 slice capabilities via cone beam CT technology... nothing new...although cone beam CT came about 15 years ago or so... such units can run approx. $300,000.00.
the DViS is first and foremost a fluoroscope, many of the mobile fluoroscopes today, e.g., the 9900 OEC can cost up to $250,000.00. these fluoroscopes are single planar multi-direction... i.e., the conventional c-shaped c-arm. in the past there have been biplanar c-arms...these didn't really gain favor.
No existing fluoroscope does what the DViS does, the biplanar models tried to gain an advantage in 2D imaging...
the DViS is like having your cake and eating it too, the cone beam CT aspect of the DViS is like the icing.
simple as that...
more importantly or interestingly, despite that biplanar c-arms didn't really gain favor, but granted they are used accordingly, but there is a neurosurgeon in florida that uses, two conventional c-shaped, i.e., multi-directional, c-arms to produce a make-shift biplanar c-arm...
a single DViS could provide so much better benefit for this neurosurgeon imho.
now, let's talk orthopedic surgeons...they could easily adapt to use of the DViS imho.
madtig, isn't it eerie the way in which the fib lines have landed on significant levels...i don't think that happens all time...
thinking back to that gap in mid-sept., and current.
that meeting will only discuss mammo and CAD (computer-aided detection). likely the FDA is going to continue their push for "outcome measures."
which sorta means that okay if something is shown to work now go a little further downstream and tell me - okay now we now it works compared to one thing (whatever) but what might that mean in tne bigger picture...
for example, CAD can be used to assist radiologists in diagnosing breast cancer. thus, it may increase specificity and sensitivity --- but will the increased specificity/sensitivity translate into preventing unnecessary tests or other medical cost during/after workup, etc.
i think the CAD discussion will be broadly based, i.e., not just pertain to mammo.
Tomography And Inverting The Radon Transform.
http://www.academicearth.org/lectures/tomography
for anyone interested this is a lecture on the mathematics behind tomography...radon transform is a type of fast fourier transform...radon is someone's name not the radioactive element.
as the prof states, it's "godsmackingly amazing." sorta entertaining to just have on in the background.
fluoro tables are radiolucent...vs. radiopaque. and such tables are either made to be used in fixed fluoro suites... or there are mobile tables that go with mobile c-arms.
in surgery, the tables are also radiolucent but sometimes some of the stuff about them get in the picture...it just depends on which angle it's necessary for the operator of the c-arm to come in from.
CT tables or couches, of course, like MRI couches, move the patient into and ouf of the CT gantry or the MRI bore.
let's assume, i dunno for sure, that IMGG will use a similar approach... or they could also move the machine in to the region of interest and go from there, i dunno.
i do know that there are portable [cone beam] ct's and some of these are used in neurosurgery/brain imaging. i have posted links to some of these units in msg's here per articles in the american journal of neuroradiology while compiling my dd...
hi joe -- first i'll say this:
i actually posted a brief reply to supercleetus, on that thread... i recognized his moniker as he was interested in an ultrasound contrast agent for myocardio-perfusion that went to an fda advisory committee last december (2008)... it got shot out of the water by the nuc med industry reps there... and plus a really unreal biostatisician on the advisory committee... regardless i digress... actually superc was either in that or was/is in NEPH...
anyway...
i also posted the link to the medison isi-2500 korea connection here... isi-2500 is a mobile fluoro/c-arm unit.
link:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42168509
a few replies that followed my post as linked above helped me to better understand the relationship between medison and the company imaging services (the "prequel" to IMGG).
now, it is correct that the medison company today specializes in ultrasound... back when i posted that link to them here (the link above) i tried to dig up any current interest with which they (medison) might have in fluoroscopy... i couldn't find any... it was merely my speculation, as i had posted, that when dean talks about overseas/asian markets as far as production goes, he probably perhaps is speaking about his ties/or inroads through medison... a few posts i believe after that earlier post (link above) i think mentions that the relationship may not be all that happy today... but nonetheless, in roads are laid imho to provide insight to his overseas/asian statements, i think even specifically mentioning korea at one point... as far as manufacturing if they (IMGG) so choose to go that route.
ultrasound is realtime, and 3d/4d ultrasound imaging is not new. anywhere i don't mention 3d/4d in this post, you can assume that the word ultrasound refers to 2d ultrasound.
the ultrasound imaging chain (from acquisition to image viewing) is vastly different from that of x-ray (in this case, fluoro). the physics are completely different, echo vs. x-ray photon attenuation... this means that as there are differences between MRI and CT, although each does sectional viewing, the goals of each device are different...as are the goals different (and thus reasons for ordering/prescription for) between ultrasound and x-ray/fluoro.
there is no conceivable way that IMGG, stole technology for the DViS from them (medison), as that dillusional poster on yahoo claims.
moreover, although i don't know this for sure, it is a safe bet on my part that medison did not invent 3d/4d ultrasound...
moreover, 2d ultrasound has been called thee functional imaging modality for soft tissue...even moreso than MRI (a soft tissue image modality). the reason why is this... you can look at soft tissue in dynamic/motion... in other words... imagine if you will, the athletic trainer (either trained specially in diagnostic ultrasound) or a sonographer for a NFL franchise looking at the rotator cuff of an injured quarter back on the side lines...some are doing this. with ultrasound it's possible for the injured arm to be moved to let the viewer (trainer/sonographer) inspect/examine the rotator cuff (soft tissue) at the shoulder joint under a dynamic/functional situation. with MRI, if you move the shoulder while acquiring the image, you'll utterly ruin the image.
4d ultrasound is most notably being used to get a "pretty picture" of babies in the womb... the diagnostic component of 4d is not clearly delineated yet to my knowledge... and actually it is a "convoluted" image...and doesn't have good contrast resolution - in laymans terms it really just stacks images up to make up a pic in 4d mode.
it is also true that ultrasound can be used for interventional procedures... particularly needle-guidance... yet, most spine specialist aren't really using it per se yet. the image contrast leaves something to be desired. the best needle-guidance i've seen is to place an i.v. in a patient that's a hard stick... i.e., hard to get a tap for whatever reason, could be as simple as said patient is dehydrated.
or how bout this, let say someone is going to have prostate seeds implanted... well, here's a situation at this time in the O.R., that involves nuclear medicine, fluoroscopy, and ultrasound...
to sum up, 3d/4d sonography has its place...2d ultrasound can be used in realtime to assess things (the things being soft tissue). ultrasound does not provide anything close to the contrast resolution or clarity that fluoroscopy does... i'll say this though, that ultrasound is gaining in areas of applications... but its role won't replace x-ray based imaging. while there are somethings that lend themselves well to being imaged in ultrasound (such as heart valves, babies, and bladders) there are many things that don't...
a final plug for the x-ray side of the house, really because of the use of contrast media (iodinated contrast dye) most things ultimately can be viewed by plain films, fluoro, or CT...
hi cchackal, IMGG will be at the annual meeting of the radiologic society of north america the week following thanksgiving. RSNA is not only a [medical] tradeshow but the largest physician conference in the world. the CEO of IMGG used to work at Toshiba's medical arm. hope this helps. my field of specialty is interventional spine care and have been published in respected medical journals, including the journals, radiologic technology and neuromodulation. i don't know who/what beacon equity is -- but i did a cursory read of their report per your link -- it read like a bunch of 5th graders wrote it...
yes, well in one of the cc's, dean stated himself that the realtime aspect of 3d imaging had been failed to be grasped by these other companies... so, one's gotta ask oneself why did these multibillion dollar companies fail to realize realtime 3d...
the patent/intellectual property is titled, "apparatus and method for three-dimensional imaging." again, broad language...however, you should look up the patent and then obtain the u.s. patent documents under the "references cited" as appears in the cover sheet/page 1.
it is patent # 7317819.
http://www.google.com/patents?q=7317819
borntwice do you 1) understand what an interventional procedure is; 2) understand what fluoroscopic guidance is; 3) when or where #1 and #2 take place; and 4) the differences between multidirectional single plane fluoroscopes and biplanar fluoroscopes.
also, do you understand what the term fluoroscope means, i'll give you this one...to view by light. think medical terminology...scope means to view, hence an otoscope views the ear...an arthoscopic procedure is viewing the joint...and an endoscope is to view the insides...
nonsurgical intervention can be used interchangeably with interventional procedures...
fluoroscopic guidance is done for both interventional and surgical procedures...
these occur in the operating room and/or fluoro suites.
all x-ray imaging is based on orthogonal views...look up orthogonal...then think about the term orthopedics.
a fluoroscope is a c-arm, a tool used by physicians during surgical- or nonsurgical- intervention.
all single plane multidirectional c-arms view things in one plane at a time to see things in 2d.
all biplanar c-arms allow 2 plane of views of 2d imagery each. for the most part, these didn't really catch on.
nothing produces 3d, except the IMGG's DViS.
you should view my prior messages to see exactly why this off the shelf product isn't a commodity and rather unique and protected by a wide patent.
there is a trend developing in medical imaging which is going toward 3d imagery... for example, for his interventional procedure, we had someone on thursday bring in his lumbar spine MRI films, and the center where his MRI was performed included an MRI myelogram (these are typically post processed to become 3d, however, these particular images where shown on film and thus typical 2d appearance -- water weighted images).
***but as to more on this trend, again, please view my prior posts and look for the abstract on this concerning CT 3d postprocessing trends which i link you to the journal, radiologic technology.
so, in summary, the DViS by IMGG represents the next generation apparatus in fluoroscopic-guidance -- which is indeed new (not a commodity) and if a maker of a fixed fluoro suite (as opposed to mobile c-arms) wants to integrate the REALTIME 3d nature that IMGG created, then they (other makers/manufacturers) will need to play ball in IMGG's court.
by the way, c-arms are not just mobile units, the fluoroscopes in fixed fluoro suites are also technically c-arms...
but what we got with the DViS is an O-arm...but not to be confused with the medtronic O-arm...AS THE MEDTRONIC O-ARM DOES NOT DO REALTIME...
well the "pre-approval $2.00" mark has been hit...and thus the correction...now, it'll just be that much easier to go there for pre-appproval/clearance going forward into RSNA [and what comes after].
do not concur why would i sell half now? in at and under .035.
we were in procedures all day today and finished around 6pm, i about fell over when i saw the pps...i'm just getting more excited the closer we move toward clearance...
"intended use" has been an ongoing thing during the review process as the FDA has tried to better understand the paradigm shif in fluoroscopic guidance that the DViS represents.
on the 9/23/09 cc...in reply to the caller's question asked at the 10:24 time point, dean references this (i.e., ongoing dialogue) by stating he addressed the caller's question at the last cc (i.e., the one prior to 9/23/09), and specifically states the phrase "intended use" at the 10:51 time point...
so, in so many words, in my opinion, my take is that we are just dotting i's and crossing t's at this point...again, it's been ongoing dialogue...and i'm sure he's not caught off-guard by the clarification request...it certainly doesn't have the feel of a revision, modification maybe, but certainly not revision...
looking forward to the next generation in fluoroscopic-guided surgery and interventional procedures.
they say the "smart money" buys in the last 1/2 hour and the first 1/2 hours is amateur hour...
when we moved our practice we insured our 9800 c-arm for $250,000.00.
The American Journal of Neuroradiology’s latest Special Collection “Radiation Dose in Neuroradiology CT Protocols” gathers recent research and guidelines on this topic in one convenient resource. Collection Editors Max Wintermark and Michael H. Lev also hosted an accompanying half-hour podcast with Pina Sanelli and Pamela Schaefer. Their discussion addresses CT quality assurance, dose reduction strategies, clinical indicators for perfusion CT, acquisition parameters, and repeat studies.
Radiation Dose in Neuroradiology CT Protocols:
Collection Editors: Max Wintermark and Michael H. Lev
By now most neuroradiologists are aware of the US Food and Drug Administration notification regarding dangerous levels of radiation exposure produced in one facility while performing CT perfusion. This unfortunate event has been front page material for the media, leading to patient anxiety and, more important, to questions regarding the use of this valuable technique. It should come as no surprise that by the time of this writing, legal action against that facility and the equipment manufacturer have been initiated. Shortly thereafter, in a different facility, a technologist scanned the same region of a child’s head 151 times! Because radiation exposure from diagnostic tests has received considerable notice—even before these 2 incidents—it behooves all of us to employ our equipment judiciously.
In a timely fashion that only electronic publication allows, Drs. Max Wintermark and Mike Lev, experts on CT perfusion, have put together a wonderful editorial (to appear in the print edition of AJNR, too) and an informative Special Collection on radiation exposure-related articles. Our series of Special Collections is biannual but when we believe that our readers and society constituency need further information, we can rapidly act and deploy educational materials that will keep us all well versed and up-to-date.
At my hospital, for nearly 3 years we have used CT protocols specifically designed to deliver the smallest possible radiation dose. Although their esthetic quality is not the finest, they contain diagnostic information that is no different than those obtained with full dosages. I believe that in most patients who need a vascular CT study—perfusion and/or CT angiography—the benefits far outweigh the risks because these diseases carry significant morbidity and mortality if not diagnosed and treated promptly. As suggested by Max and Mike, the creation of a repository of ideal CT protocols is a laudable idea. AJNRBlog.org would be the ideal place for it. Further information regarding radiation exposure may be found at the Image Gently campaign.
M. Castillo
Editor-in-Chief
http://www.ajnr.org/specCol/specCollPCTToc.dtl
M. Wintermark and M.H. Lev
FDA Investigates the Safety of Brain Perfusion CT
AJNR Am J Neuroradiol 10.3174/ajnr.A1967 [PDF]
http://www.ajnr.org/cgi/reprint/ajnr.A1967v1
Podcast:
http://www.ajnr.org/misc/Podcast.dtl
hi joe/dandrew -- imho, above my paygrade, i think that it would not be "illegal" i think they'd/whomever would just need to file to make public knowledge of ownership...if said purchase is at the at/greater than the 5% level of outstanding shares...
e.g., i see no reason it wouldn't be the same as say a hedge fund taking ownership...or say, carl icann taking a 10% stake in a co. just to make sure his voice is heard by the boardof directors...
i know i've heard of it before, maybe, i think banks have done this...when buying up other banks, but i'm just going by hazy memory there...
however, as to why wouldn't any of the biggies put a bid in prior to FDA approval... all speculation...
however, as i pointed out previously, i'm interested in finding out as the picture unfolds if any of say -- makers of fixed fluoro suites (non-mobile/non-portable) will adapt realtime 3d fluoroscopy/fluorography, as the patent is wide... and would need to be walked through.
btw, thanks for asking about my abstracts...they are prepared and we are at the stage of either having medtronic and boston scientific cover the cost of posters/prints or if we'll just cover the expense ourselves... minor issue... the abstracts are good stuff...
fda video on 510k submission tracking decision... toward the end of the video they tell you what the clearance/approval letter is all about - why/how it's mailed etc. etc...
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm
scroll down to fda's "log-in procedure" and watch...
fink - on 3d images here's what i think...
they will look like...using an educational guess...
this isn't real-time 3d but it's sorta what i spoke about in a post over the weekend on the DViS making the modified c-arm obsolete....
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=43107944
anyway, have fun looking at the images below...
http://www.ajnr.org/cgi/reprint/18/8/1507
also you ought to look up "digital subtraction" imaging as the DViS can and should have those capabilities...
yes, thx, just wanted a 2nd opinion on the current state of neurality... i also agree news trump ta...
fda video on 510k submission tracking decision...
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm
scroll down to fda's "log-in procedure" and watch...
madtig, looking at the secondary indicators (or whatever they are called), do you think in the event of an upside breakout...that that breakout would occur from -- a not oversold environment...
more on cone beam CT... surgical applications. i've posted earlier on it here with respect to head and ENT applications viat the american journal of neuroradiology articles -- of which the portable CT article discuss high and low contrast imagery...just click my moniker and you can get to that post under my name.
but, everyone's gotta look at this commercial product available...and think to yourself -- wow the DViS could make this obsolete...
the link is embedded in my post i'm posting here which i'm "borrowing" from the yahoo thread...
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i think DViS does not do 32 or 64... the 16 slice was the industry standard for a long time. the advantage of more slices is that smaller things could be detected...
however, what i don't know is if future models may.
likewise, here's an interesting thing:
there's an ED (emergency department) in a hospital in florida... it has the Siemen's Somaton Sensation CT scanner...this particular scanner is configured to be a 32 slice MSCT, although the model was available, a few years ago at the time of purchase, as either a 32 slice or 64 slice.
16 slice will be ample for surgical intent... and i gotta pause and link this article...
again wait'll they get ahold of the DViS
http://download.journals.elsevierhealth.com/pdfs/journals/1051-0443/PIIS1051044309003236.pdf
i would image that the DViS would make this direction obsolete.
back to slices:
sure there are advantages and disadvantages...but, i wonder if a 32 slice DViS would be plausible... for example, Hitachi, i believe, has the capacity to scan in 64 slice and reconfigure either way, 32 or 64.
my biomedical engineer states that computing power (i.e., via silicon chip technology) is doubling every 18 months, what i don't know is if that would be noteworthy to be applicable here.
also, similarly interesting, that same hospital in florida upgraded its MRI scanner to a Siemens’ MAGNETOM Harmony 1.0 T (tesla). most people would laugh at that 1.5 tesla could be considered the industry scanner of superconducting MRI's (there are different types)...a high-field magnet is 3.0 tesla. what was upgraded was the software...
regardless this is the hospital's MRI.
there are some types of MRIs which are "low" field but enable weight bearing applications... the issue here though is that it take a lot of electricity to run and images aren't as pretty as the higher field strengths. but, we send a lot of people to it because it is the ultimate open MRI at this time... important for claustrophic patients. it is by FONAR, the company of the guy who invented the MRI.
i'm not that all surprised a resident/fellow/new doc wouldn't have heard of the DViS. they got a boatload of stuff just to be concerned with for passing exams...
however, to post this post again... the trend is apparent, 3D imaging is catching on...this article pertains to CT and doesn't include MRI 3d imaging (although the later isn't all that hot yet)... these though are post processed...just like the title of the article says... a lot of times 3D CT post processed images are used for preparing surgerical cases... i.e., for certain cases they have the patient get a CT scan so they can plan out the surgery...virtually.
so, wait'll they get ahold of the realtime 3d fluoro machine...
trends in 3d imaging...
http://radiologictechnology.org/cgi/content/abstract/81/1/24
Radiologic Technology, 81:24-31 2009
Trends in 3-D CT Postprocessing
LAURA PIERCE, MPA, R.T.(R)(CT), JARRETT ROSENBERG, PhD and SANDRA NEUSTEL, PhD
Purpose The increasing number of multidetector CT scanners in radiology departments has intensified demand for 3-D imaging. This study sought to reveal the frequency and type of postprocessing tasks being performed by computed tomography (CT) technologists by discussing the longitudinal results of the American Registry of Radiologic Technologists (ARRT) CT practice analysis surveys from 1993 to 2007.
Method In 1993, 2001 and 2007, the ARRT mailed CT job analysis surveys to a national randomized sample of 1000 radiologic technologists per year who were employed full time in CT, for a combined total of 3000. A usable sample of 1476 responses from the 3 surveys revealed technologists’ level of responsibility for a variety of CT tasks, including 3-D imaging.
Results The proportion of respondents responsible for 3-D imaging increased from 47% in 1993 to 74% in 2001 and to 82% in 2007 (P< .001). This increase occurred in all employment settings (P < .001) and department sizes (P < .001), including small departments. Daily frequency of occurrence grew from 4% in 1993 to 11% in 2001 and 53% in 2007 (P< .001).
Conclusion Routine 3-D postprocessing has become typical practice in radiology CT departments across all employment settings.
fda wants clarification, not revision, and not a big deal...
the fda requested clarifiation of intended use...
not what is the intended use... yes, philosophically maybe one in the same but not technically.
i had stated on thursday night that dean's originally submitted intended use statement (from back in the day) had been narrowed during the review process...i got that from the context of the prior calls, things said, and the context of the current cc...
(i encourage everyone who has concerns to go ahead and listen again to the cc and i believe you will understand this.)
i truly believe i'm right about this...and we will get what we know the DViS is all about...because due to the original and revised intedned use statement, the fda is just asking for clarity on the topic.
WHAT THIS MEANS: the fda wants only clarification...
i think that the recently submitted QA images were key:
i think we get what we want...
1.// fluoroscopic guidance
2.// cone beam CT: uses where 16 slices are sufficient.
interventional (image guided procedures/use for minimally invasive and invasive type sugeries) and presurgery planning, perhaps even reassessment of radiotherapy progress...this is all about image-guidance.
i think we get the digital subtraction feature on the DViS... important for angiographic procedures.
other uses, such as mammo, weight-bearing, and hybrid imaging (i.e., PECT/CT) are down the road...
i think so --- it appears so... which is what i had inferred from the initial reasons on request for the QA high contrast low contrast imagery by the FDA... knowing what high contrast and low contrast means, i thought well the FDA is getting it, the concept of the device... by at least wanting to look at what we inspect annually or biannually for CT (as well as fluoroscopy). however, i don't want to take a guess as to what the predicate substantially equivalent device(s) is/are going to be as appears on the application... although, in the clearance letter by the FDA, it will state it, and thus we will find out.
pertaining to the concept of the device as a combo device, i really don't even know if the FDA allows an applicant to list more than one predicate device. i can't remember for sure ever noting that on the one's i've looked at. i know patents do allow this, as it is critical to the application process for patents... regardless if the FDA wanted to look at high low contrast imagery for the CT feature of the DViS then i still think they get the point...that this is a mobile fluoroscope/cone beam CT device.
bottom line: i can't imaging the labeling aspect cutting off one or the other... as there is such a thing as CT-fluoroscopy, simply put, that is just running a CT scanner continuously and updating the slices continuously through the imaging chain as viewed, it isn't nearly the same thing as a fluoroscope and doesn't even come close to what the DViS does in fluoroscopy mode...
chevyman, on that page to the medical devices site...from the link.
on your computer do a (ctrl "f") with your keyboard keys hold down the contorl key and then the f key... this means "control find" and brings up a small window to type in a keyword(s) search on a webpage...
to this and then type in the word "label." you'll find a little more insight on "labeling" and "use."
as far as finding an equivalent... i presume yes...in the bigger picture...
thus, i again think the labeling thing is dotting i's crossing t's.
however, as simple as this dotting i's and crossing t's can be, i think it is wise that dean is going to reply to the FDA thoughtfully (i.e., not just send in a working prefab templated indication statement), and consider the FDA progress pertaining to the DViS and take a week and a half or so as his time-point goal to reply to them...
ask yourself this, did you ever have an idea and then try to put it down on paper and then have the pencil/pen in your hand and not be able to write... i've submitted manuscript for peer-reviewed medical journals... to write an abstract of the article is sometimes sorta tough depending on the article content. the abstract tells the readers what the article is... but the editor for the publication want the author(s) to also submit a cover letter telling them what it is... but wait isn't this what the abstract is... which is already a necessary piece of the manuscript pie... it can sorta hard to again paraphrase what you've already paraphrased... and the authors are speaking as the experts who have an intimate insight of the topic... i'm drifting but hopefully you get my point...
dean's gotta take in all the recent inquires by the FDA on the DViS and act accordingly to what the DViS is...in his reply.
for example, i've looked at this post 3 times in preview and made some corrections before submitting it.
dominion - what it is...
the DViS isn't going to replace MSCT (multislice ct) scanners, as these can produce way more slices (thinner) slices...and thus chop up organs to detect things...
the DViS provides 16 slice capabilities via cone beam CT technology... nothing new...although cone beam CT came about 15 years ago or so...
the DViS isn't going to replace MRI machines: the two things CT and MRI are completely different... these two types of imaging have different goals and utilize different physics (way different) to achieve these goals.
the DViS is first and foremost a fluoroscope, many of the mobile fluoroscopes today, e.g., the 9900 OEC can cost up to $250,000.00. these fluoroscopes are single planar multi-direction... i.e., the conventional c-shaped c-arm. in the past there have been biplanar c-arms...these didn't really gain favor.
No existing fluoroscope does what the DViS does, the biplanar models tried to gain an advantage in 2D imaging...
so, as one of the rare posters on the yahoo board (who is a medical physicist) and i agree, the DViS is the *** next generation apparatus in fluoroscopically-guided surgery/procedures.
the DViS is like having your cake and eating it too, the cone beam CT aspect of the DViS is like the icing.
simple as that...
more importantly or interestingly, despite that biplanar c-arms didn't really gain favor, but granted they are used accordingly, but there is a neurosurgeon in florida that uses, two conventional c-shaped, i.e., multi-directional, c-arms to produce a make-shift biplanar c-arm...
a single DViS could provide so much better benefit for this neurosurgeon imho.
chevyman -- under the medical devices section...
NEW DEVICES THAT ARE COMBINATIONS OF OLD DEVICES
A new device is a so-called "combination" device when it claims to have the same intended uses as two or more different types of predicate devices. Normally, this is achieved by combining two or more predicate devices into a device that is sold as a unit, e.g., a urinary catheter may incorporate a temperature measuring device; or a cardiac monitor, electrocardiograph, and blood pressure computer that were sold separately prior to May 28, 1976, might be combined into one electronic monitoring device.
When a new device combines types of devices from different classes, questions have arisen about what classification the new device will have.
In its review of the 510(k), the Center will subject the combination device to the same sorts of questions and documentation requirements that are applied to a single device. When such a device is found to be SE, it combines devices from different classes and is classified in the highest of the predicate device classifications unless the combined devices are regulatable as separate articles, e.g., they are detachable. In that case, the separately regulatable articles will be regulated in separate classes.
1/ H.R. Rep. No. 94-853 pp. 36-37. The Amendments, as enacted, are comprised primarily of the bill H.R. 11124 as drafted by the Subcommittee on Health and the environment of the Committee on Interstate and Foreign Commerce and adopted by the House of Representatives. This report provides the only Congressional guidance on the criteria for substantial equivalence.
2/ This document does not provide guidance on what changes in marketed devices are significant enough to require the submission of a 510(k), but the Center plans to issue such guidance in the near future.
3/ Ordinarily, intended use is determined by reference to "labeling" or promotional claims; only in rare cases might it be necessary to infer intended use from other types of information.
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081383.htm
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thus, as i've stated:
the fda wanted QA data = high/low contrast data for the cone beam CT specifically...
i took that to mean that the FDA was seriously considering the cone beam CT aspect of the DViS...
now = it sounds like the FDA has hammered out the comparable issue and got some objective data from those images which were sent in...please refer to number 3 above.
new device = dominion DViS:
a combination of
1.// fluoro
2.// cone beam CT.
a mobile combination of these two things...
new because it is the only device/mobile device to provide realtime 3D imaging.
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from my earlier post:
yes images were QA (quality assurance), and remember they were pertinent to the CT (i.e., cone beam CT) feature only...as we understood from previous...
in the world of CT, the QA aspect is what an operator would do for documenting the units are calibrated to standards for quality control.
however, annually or biannually a medical physicist ensures high/low contrast (among other batteries of tests, referred to as physics acceptance standards), and annually companies do PM, i.e., preventative maintenance.
i take the actual requested images (now old news, as they were submitted and now the FDA just wants to finalize labeling) this to mean that the FDA took the CT component seriously.
by the way, both acceptance testing and PMs are done in fluoro too. so the same concepts would apply to the fluoro features. QA as far as imagery isn't really necessary for daily/weekly performance in mobile fluoro...
the concepts of these tests are to provide objective data (both for the FDA and for the real world ultimately upon clearance), and is why patient or clinical images aren't necessary.
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in the prior cc's, he stated he "narrowed the use" or maybe more specifically limited the application by not applying for use in mammo or in weight bearing applications...in order not to muddle the waters...and that those two uses could be applied for after initial clearance.
i suspect two uses will the two uses will be:
1.// fluoroscopically-guided procedures/surgery -- i would think this would be all inclusive, and not state which types.
2.// cone-beam CT -- any part of the body or some part of the body, etc.
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i'll have to wait to listen again to the cc to pick up on the context of any mention of '...narrowed the use...', i had get out of the call early. i remember that that synopsis post posted by nihonto chicken state weight bearing so perhaps that was the context for the narrowed the use comment here again, or even as PET/CT hybrid use...but all these surely are plausible future indications.