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hi shappy, dean appears but not as a featured guest... it after the first two featured guests... cheers...
mr. sano --- getting back to "what is conebeam ct" it probably best just to repost this... i can tell you that as far as which generation conventional CT scanners are most typical, most typical are the 3rd generation scanners. it was good to go through this again...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42630231
read the first article, title, "Conebeam CT of the Head and Neck, Part 1: Physical Principles."
"Data acquisition in conventional CT imaging has evolved through 4 generations of acquisition geometries. First-generation scanners used parallel pencil beams of x-rays and required both translation and rotation of the source and a single-detector apparatus. Second-generation scanners introduced fan-beam x-ray geometry and used a single-detector linear array. In third-generation scanners, the single-detector arc was introduced in conjunction with fan-beam x-ray geometry. Fourth-generation scanners used a fan-beam of x-rays and a circular detector array. In current practice, multidetector helical CT (MDCT) scanning is most frequently used, answering the call for reduced acquisition times. MDCT is loosely based on third-generation geometry, though the detector array has multiple rows of detectors."
--- okay, here's the basic concept of a conebeam...per the same article (see figure 2) to see a picture/drawing comparing fan-beam to cone-beam.
"Data Acquisition
In CBCT systems, the x-ray beam forms a conical geometry between the source (apex) and the detector (base) (Fig 2). This is in contrast to conventional fan-beam geometry (Fig 2), in which the collimator restricts the x-ray beam to approximately 2D geometry. In a fan-beam single-detector arc geometry, data acquisition requires both rotation and z-direction translation of the gantry to eventually construct an image set composed of multiple axial sections. In CBCT systems using a 2D FPD, however, an entire volumetric dataset can be acquired with a single rotation of the gantry. Incident photons on multiple-row detectors in MDCT actually fall on a 2D area of detectors, as with flat-panel detection; indeed, with increasing numbers of rows in MDCT detector arrays, the acquisition geometry actually approximates that of a conebeam system."
--- okay, also make sure you look what can be viewed as a typical non-3d post processed CBCT image... it's figure 3 in the same article. it's really pretty much similar to any non-3d post processed 3d CT image.
*****
here's a picture of a third generation scanner from my fav cyclopedia...not wiki...
http://www.medcyclopaedia.com/library/radiology/chapter04/4_2.aspx
here's a picture of a fourth generation gantry...
http://radiographics.rsna.org/content/22/4/949/F7.expansion
*****
i highly encourage you to take a look at these animation clips...it'll paint a picture of the third generation MDCT... in particular the "detector plate" clip.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=43836146
*****
from my reading it appears as CT manufacturers are attempting to move toward flat planel detectors...meaning perhaps the fourth generation gantry won't really become the norm.
ndforlife re: mammo...
first: there are 3 types of biomedical engineers...but before i list them, it would be good to differentiate how engineers are different than scientist, how? -- engineers are problem solvers to make things happen, they understand the science in the pragmatic sense...
- entrepreneurial (the rarest).
- research.
- clinical.
dean is first and foremost the first of these, therefore when he speaks of mammo, it's not to him (imo) a question of should we adapt the DViS, it's a matter of okay how do we go about to make this happen...
imho, this application would be the most scruntinized -- just by the existing rules/reguations on mammo (see somewhat what i mean below) -- of the three applications he has mentioned going forward after initial clearance... the other two being 1) adjunct to radiotherapy planning, and 2) an applicable application to weight bearing exams... of which the latter is most interesting to me because it would be a new thing, i'm not aware of any CT which can be used to conduct weight bearing examinations... and for all of these we are talking the CT feature of the DViS in my opinion. [by the way, in the world of plain films weight bearing x-rays are typically taken to evaluate the hips and/or knees and/or feet. of which these are ordered sorta frequently. if an apparatus existed to apply weight bearing exams in CT for these joints it would obviously be used for orthopedic surgery planning.]
back to mammo: as has been elluded to here last month the FDA meet to discuss [x-ray digital imagery procurement] mammo and then CAD (computed aided detection)...in mid november... see my post IHUB post number 5451 to get a take on the outcome of that per an auntminnie reporter.
such an indication of the DViS would need to have something set up to follow those recommendations or at least be somewhat in sync with them, etc... would need to meet primary/secondary endpoints i think...
therefore, it would be a bigger hurdle than indications/use for radiation therapy planning and/or a truly new CT application applied for weight bearing exams...
here's something to consider now though... while mammo is the term used to describe an x-ray exam... there are ultrasound indications for breast cancer detection... and, in 2007 i believe it was, the american cancer society came out recommending MRI of the breast cancer detection (sorta of a test to make a differential diagnosis) for women at high risk for cancer (familial history and interesting mammo/ultrasound images)... i'm not sure of the exact story behind MRI's evolution into that arena, but nevertheless, we now have that recommendation, afterall MRI is a detector used to examine any soft tissues by providing good contrast imagery of them...
if the DViS could somehow be adapted to provide an exam for this arena it would be at the level of the mammo, not ultrasound or MRI...
mammo requires softer x-rays and in CT mode the DViS would be of a greater advantage than the harder x-rays from most CTs...in fact, there was a study on the risks of breast cancer development associated with CTA (CT-angiograms of the heart), i don't recall the results...
i would image the DViS, if dean decides to pursue some application in this arena would be somewhat scaled...i dunno...like maybe take thinner slices, perhaps 32 slices...
there are strict and stringent regulations on mammo x-ray systems in order to ensure the performance of such systems, i.e., there are greater quality assurance requirements compared to other x-ray systems.
dean is well-aware of all this, as he has frequently mentioned (or touched on it) in cc's, and for which he went on to state in his reply to you in the most recent one...i.e., something about going down that path would muddy up the 510K and so he opted to pursue the most straight and generic indications (i'm very happy concerning the latter change to a more generic wording)...also, the latter being great for everyone here, and the medical community.
on that note: i'm not sure what he'll decide to eventually do...
this post is only merely to provide a little color on the topic...
least we not forget, the underbelly of all of this is the comments from some government committee with what became a highly controvesial issue in women's health -- of recommending guidelines which post pone initial mammo exams until up to 10 years later for women... for whatever motivation the committee had...
haven't you seen the revolving hand/wrist or revolving skull on their website... i think these are what you are referring too. i think these are the rudimentary images... i also think someone who attended RSNA stated the skull imagery was what was used at RSNA.
and note: in fluoro bones are black and on plain films bones are white... with fluoro systems you view bones in black and a white "background," but you can also negate the image... make them look like a plain film... by making the bone white and the "background" black... you can see the negating happen with watching the revolving hand/wrist when you watch...
to people who are used to viewing these things, one can interpolate what a foot/ankle will look like...
mr. sano, to professionals who understand imaging clearly understands what he is saying re: compression ... i'm listening to the 12/9/09 call now, i don't see the compression thing as being a road-block ...
in imaging: diagnostic imagery is often interpretated by radiologist remotely located. the images are sent...either through the hospital by PACS or across continents by PACS/DICOM.
in fluoroscopy: the fluoroscope is a surgerical/interventional tool... the images are interpreted live at the moment of the surgery/intervention as the patient is on the table, as you watch the screen.
the images are like watching t.v., frequently only 1 or 2 case-relevant images [or frames on the monitor] are ever saved/recorded to document the surgery or some remarkable find or complication -- during lets say a 3 minute total fluoro time for a 35 minute total procedure time... there are also "cine runs" which are applicable in some surgeries, usually to check vessel patency.
moreover, while talking to the cardiologist he goes into techno babble to address images and compression... he speaks about DICOM...
now, our 9800 OEC c-arm is not PACS/DICOM capatible, we can not send images to some remote location... it is not necessary for us... we use other means to archive: hardcopies or burning images to a CD...
in the meantime, i want dean to protect his proprietary DViS system til FDA approval/clearance by keeping all relative images in the hands of the FDA, that'll be far more beneficial for us shareholders.
re: labeling: dean clearly provides an example on the 12/9/09 cc at time mark 33:00 as to what he did with the labeling... he made it more generic...
to quote or paraphrase: "say if you just say, orthopedics, ya know orthopedics include orthopedic surgery, it includes sports medicine, spinal surgery, instead of listing out all these typical uses, in a generic sense you're already opening up all those uses."
listening to the 12/9/09 cc, the whole conversation with the cardiologist was golden... it starts at time mark 22:30...
he mentions he thinks the DViS will be beneficial for:
Triple A repairs = AAA = abdominal aortic aneurysm...
CT = cardiothoracic surgery...
Thoracic aneurysm repair...
Abdominal aneurysm repair...
oneoldfish --- sounds like are you talking about spinal cord stimulation via paddle leads or percutaneous (wire) leads ... if so, that is our specialty ... neuromodulation.
borntwice --- part 2 of 2 ... asterisks added by me...
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
borntwice --- part 1 of 2 ...
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
i concur lennygoat... i just woke up and was thinking about this... actually i think it has been discussed/mentioned or whatever before in prior calls... which speaks to why i'd stated something similar on my reply (without even hearing the more recent call yesterday)... so for me, this confirms my thinking... thanks...
and mr. sano...about your quesiton on non-human data files/images
#1.// sounds like dean wants best case scenario, i.e., lennygoat's post...
#2.// why put up pictures which aren't of your targeted audience/patient population... (as an shareholder, i would not want that)...
chevyman,
i have not heard the cc, and haven't heard the context or the way it was worded...but read something on that in the post by stock777...
i don't know if he means "placement of images onto a website." i believe i have heard this discussed in the past... i will say i absolutely applaud the fact that he isn't monkeying around with doing that while the 510K review is going on...
regardless stock777's summary post stated the word "compression," which it is merely a transmission thing and not an acquisition thing... THINK OF IT AS A ZIP FILE ON YOUR COMPUTER...
at any rate, this is per a standard by the american college of radiology...I RECOMMEND LINKING INTO THE PAGE PER LINK BELOW...
ACR TECHNICAL STANDARD FOR ELECTRONIC PRACTICE OF MEDICAL IMAGING
I. INTRODUCTION
Increasingly, medical imaging and patient information are being managed utilizing digital data during acquisition, transmission, storage, display, interpretation, and consultation. The management of these data during each of these operations may have an impact on the quality of patient care.
These standards are applicable to any system of digital image data management, from a single-modality or single-use system to a complete picture archiving and communication system (PACS) to the electronic transmission of radiologic images from one location to another for the purposes of interpretation and/or consultation.
This standard defines goals, qualifications of personnel, equipment guidelines, specifications of data manipulation and management, and quality control and quality improvement procedures for the use of digital image data that should result in high-quality radiological care.
In all cases for which an American College of Radiology (ACR) Practice Guideline or Technical Standard exists for the modality being used or the specific examination being performed, that guideline or standard will continue ACR TECHNICAL STANDARD to apply when digital image data management systems are used. A glossary of commonly used terminology (Appendix A) and a reference list are included.
allow me to skip to this...
B. Compression
Data compression may be performed to facilitate transmission and storage. The type of medical image, the modality, and the objective of the study will determine the degree of acceptable compression. Several methods, including both reversible and irreversible techniques (lossless and lossy are also common terms), may be used under the direction of a qualified physician or practitioner, with minimal if any reduction in clinical diagnostic image quality. If compression is used, algorithms recommended by the DICOM standard such as wavelet or JPEG-2000 compression methods should be used. The types and ratios of compression used for different imaging studies transmitted and stored by the system should be selected and periodically reviewed by the responsible physician to ensure appropriate clinical image quality. Regulatory bodies may require the compression ratio used to be indicated on the compressed image. The Food and Drug Administration (FDA) does not allow compression of digital mammograms at this time for retention, transmission, or final interpretation.
http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/med_phys/electronic_practice.aspx
per the glossary:
Compression ratio - the ratio of the number of bits in an original image to that in a compressed version of that image. For example, a compression ratio of 2:1 would correspond to a compressed image with one-half the number of bits of the original.
finally, for tonight... on dose...
we have already touched on this to a degree... in the discussion a couple weeks ago on imaging of obese/morbidly obese... the article which i posted at that time had to do with resetting some common dose parameters on dose charts as the "old school" reference phantoms may not account for the body habitus (i.e., type) in today's population... i.e., a more heavier set population... this would go hand in hand with increasing medical radiation exposure... at a population level... a health physics concept.
however, what else plays a role is medicolegal issues and alternatively healthcare economics --- [although i don't want to discuss the latter] --- you think a doctor isn't going to order at least plain films (an "x-ray") if you come to him/her with some sorta ache or complaint... the doc doesn't want to get sued down the road...for not doing so...
there was actually a really good discussion on this on an NPR program...
an ER doc at a teaching cite did not want to perform a CT on a girl who came into the ER following a car wreck or something...as the doc didn't think it was necessary and the CT wouldn't show anything of relevance. the father went bersek... although, a rational discussion took place... finally, although it was against his medical opninion, the doc finally gave in just to get on with performing other stuff he had to do and not "waste" anymore time and go on to see other patients... the CT scan was negative (i.e., it didn't show anything).
hi, and here's one more thought --- as far as what i said about articles on pedicle screws and occupational exposure to physicians [which ties in to my earlier post on dose and regulations]. the exposure articles on this that i'm thinking about are on hand exposure data...
the badges i spoke about earlier tonight are typically worn at the collar or chest... however, there are ring badges which are worn on the physicians dominant hand... these dosimeters are what are referred to as TLD... thermoluminescence dosimeters... a slightly different mechanism than OSL dosimeters...
however, extremity exposure has the largest acceptabe occupational dose limit(s) as the skin is technically very radioresistant...
yes, there are many probably well over a hundred or so articles on pedicle screw placements...
both on techniques and on exposure to physicians whom perform this.
in my opinion, this is just the sorta surgical procedure i think the DViS would be beneficial for...
go from 3d realtime fluoro to a CT view using the same machine/system... gotta love it...
in all imaging you absolutely need to have at least two images taken at 90 degrees to one another, i.e., perpendicular...
this is the only way you can observe depth and direction in relation to each picture...
ortho means straight...
orthogonal means right... as in a right angle, 90 degrees...
orthopaedics well, there you have it...
but, along comes the DViS, and you can obtain depth perception in fluoro and simply "spin" the image on the monitor if you want... by "spinning" the 3d fluoro image [on the monitor] you would uniquely be able to judge insertion... however, the CT feature would be very reassuring...
in regard to radiation safety in fluoroscopy...
i had some fun playing tag with a yahoo poster about radiation...
it dawned on me that many probably aren't aware of the regulations...re: patient/occupational exposure...
thus, i wanted to provide some insights...
first off -- there are annual dose "restrictions." all employees wear personal dosimeters, or dose meters... these don't absorb radiation, but rather record it. it is part of the radiation safety program... most large centers have a radiation safety officer. and small centers will have an "individual responsible for radiation protection." but also, often these two titles are co-titles or similar hats worn by the same person.
the most common badge is the Luxel OSL (optically stimulated dosimetry) badge...it is highly sensitive and is a tough little badge as well... it is made by LANDAUER... even, speech and language pathologists will wear these because SLPs assess patients ability to properly swallow (if thought to be at risk, like think stroke patients, e.g.) so as to not put patients at risk for pneumonia, etc... these tests are done in the radiology dept. and it is referred to as a modified barium swallow exam. we actually watch someone chew and swallow... this would be performed in a fixed-fluoro room...
i just wanted to provide this example -- because one may not think of this branch/discipline as being a "badged employee."
here is the pdf on the Luxel OSL badge...
http://www.osldosimetry.com/documents/Luxel.pdf
*****
as well -- here is a good article on radiation safety in fluoroscopy, as a matter of fact -- it's the name of the article... asterisks added by me for emphasis...
*****
Radiol Technol. 2002 Jul-Aug;73(6):511-33; quiz 534-6, 566.
Radiation safety in fluoroscopy.
Norris TG.
Radiol Technol. 2002 Nov-Dec;74(2):132..
Fluoroscopy is an important diagnostic and interventional imaging tool that enables clinicians to view dynamic, real-time images of anatomy and function unmatched by other imaging techniques. However, operators must take into account many factors that impact the amount of radiation delivered, particularly over the course of a lengthy interventional procedure. After completing this review, readers will: Understand basic concepts of radiobiology and fluoroscopy systems. Know the typical doses and dose calculations for patients and fluoroscopic personnel. Recognize the pathology of biological effects and common radiation-induced skin injuries. ***Understand fluoroscopic technique factors to reduce patient exposure. Know the basic methods for controlling occupational exposure for fluoroscopic personnel.***
PMID: 12154656 [PubMed - indexed for MEDLINE]
thanks all for the cc posts... i didn't get to listen and enjoyed the synopsis... i'm looking forward to listening once posted on the website.
this is as i would expect...
i have listed...
portable ct scanners (cone-beam or non cone beam).
c-arms modified to be ct-like.
c-arms modified to give something in 3d (post processed only, not realtime).
then on the medtronic o-arm (again post processed only, not realtime).
all these things above are currently out there...
now for example, i don't feel that the DViS will do CTA (aka CT angiography), and don't feel it was ever intended to go down that path...
the DViS is unique yet substantially equivalent, and my thoughts are that the realtime 3d application will be of value to the big players... i have posted links to articles on trends in CT 3d post processed images...the article shows clear evidence of that... which i only allude to because the trending aspect in imaging is toward 3d...even post processed reconstructed MR images is happening... however, 3d fluoro (fluoro = realtime) is owned by IMGG.
seems to me to be clear cut. mathematically i can't think of any other way to obtain 3d realtime fluoro without an o-arm (of the gantry type -- the medtronic o-arm is my opinion is not a true gantry it just isn't)... it has to do with the Radon Transform (it is a mathematical tranform of the Fourier type)... btw, Radon is not the radioactive element, it is someone's name. the Radon Transform is the mathematics behind computed tomograhy, and for that matter MRI... i.e., the things that do sectional imaging...
for mri the gantry is termed the bore.
something interesting...on a different note...at the conference i was at over last weekend... steps are progressing to make MRI-guided interventional procedures more commonplace for some procedures...
gates57 we are not a PMA we are class 2.
hi mr. sano, as far as what is cone beam ct -- that's actually a great question... and a timely post by chem #6293 is a good starting point, i've posted on some articles directly dealing with cone beam ct's currently on the market -- radiological type (compared to let's say the dental type) -- with links to those articles as from the american journal of neuroradiology.
i won't have time to write up a more thorough post and compare/contrast to non-cone beam ct's post till maybe thursday night...
thanks, btw, there was a lady who spoke at the conf. on regulatory matters concerning getting a device into review... most stuff for us was relative to PMA and not so much 510k... it was great info, but not really all that new to what many already know...
in general, wanted to show you all an interesting apparatus from a company waiting for the 4th in a line of 4 510K clearances... they were at the conference this past weekend...
they aren't public, so it's not really OT.
and anyways, this is directly related to interventional procedures...however, it has to do with MRI-guided procedures...
don't worry, such image-guidance won't make fluoro-guidance obsolete...heck they've been doing CT-guidance for a while now too...
MRI-guidance is new...honestly, i was sorta disappointed they weren't public...
anyway, here's the link to the website if anyone's interested...
just so you'll note it, the image of the brain on the homepage is an MR image.
http://surgivision.com/
mr. sano, did you come to the conclusion based on that radiology paper, that the DViS is class 2... per my reply to your direct question last week. looks like you never responded back... wanna make sure you saw it...
mr. sano/toughcasey, if you read the post i made today which links to the article from "radiology." i think you'll also agree that the DViS is class II.
i'm trying to comprehend what others are concerned about when it comes to the whole intended use thing...
so, maybe this is just a naive thought, but my logic tells me this...
the DViS is a fluoroscope first... with this in mind, it would seem to me that anywhere a physician will need to have realtime image guidance which is achieved through the assistance of a mobile unit (as provided by mobile fluoroscopy systems), it would be indicated.
what might be the thing which is being clarified with intended use is in regard to it's secondary feature, the cone beam CT technology. however, there are current portable cone beam CTs, which many, not all, are built/designed for an "application of specialty." so, maybe this is it, and i'd say okay, i'll give you that, but again, i really can't get my mind wrappped around that either...
it would seem that a "restriction" of the label would be, say, as compared to, something that is like the aquilion CT scanner... like for instance, okay the DViS is not intended to be used to perform CTAs, or computed tomography angiography, think coronary angios...
however, that just makes sense to me and i wouldn't think it would've been down that road to begin with...
or perhaps, there is discussion about whether the CT feature could be used for CT-guided biopsies... most typical application would be for lung biopsies. but, i don't know, 16 slice scanners were the industry norm til recently.
could it be used to assist radiation therapy planning, i would think yes, maybe... that sorta makes sense, and has been discussed by IMGG in the past...
back to "portable" CT scanners:
are portable CTs used for some surgeries, yes...again, it's one reason that they exist.
*****
unique to the DViS, as far as i'm aware, no one has weight-bearing CT applications... can the DViS do this, we are told yes. is weight bearing done in radiography, yes.
the interesting concept with this application is that...could it be used to help plan orthopaedic surgery on the knee... it would seem yes...
however, it is our understanding that this aspect of intended use will be applied for after initial clearance/approval...
*****
the real-magic, is that 3d imagery is becoming more commonplace. however, all is post processed, but nonetheless postprocessed 3d imaging is becoming more common place...for both CT and MRI...
heck, even i read sony is coming out with a new HD TV with 3d availability for some features... heck, even director james cameron has developed a new camera to film a 3d movie.
it would seem that that is where the value of the DViS and IMGG is herein... it would seem that a realtime 3d fluoroscope would have great benefit to the imaging world's "big brothers".
with respect to fluoro... here's a "can you imagine" scenario... can you imagine your orthopod having the technology to operate under realtime 3d fluoro and [maybe just having the radiologic technologist touching the screen to rotate the perspectives to view all perpendicular angles like many of these new phones have the applications to rotate the image by using your finger to scroll the "3d image."
from what i've heard/read in my dd, that is sorta how the DViS goes from one view to the other perpendicular view (which is an absolute must -- ortho means straight and orthogonal means right angle). of course, i've not read/heard anything in my dd, on the ability to do this by using a finger on screen... however, i believe the image may rotate like that via the operator... that would seem possible.
keep in mind though that current c-arms have touch screen features (not new), and that, again, in computer engineering, there is a trend on doubling computing power every 18 months. so who knows..."can you imagine" that... i can
all, IMO
Re: regulations/labeling, "off-label," etc...
i had had this article saved on another pc of mine and happened acrossed it the other day... it is dated 2001, but i think it is written well enough to give those not too familiar with the process/concepts some good insights...a good "primer" or tutorial if you will... it relates directly to radiology and is a smooth read... REMEMBER the DViS is class II.
*****
http://radiology.rsna.org/content/218/2/329.full?sid=025f65a7-4d62-4146-85cc-3888d7df832b
Radiology February 2001 218:329-335
Regulation of Medical Devices in Radiology: Current Standards and Future Opportunities1
John J. Smith, MD, JD
+ Author Affiliations
1From the Department of Radiology, Massachusetts General Hospital, 55 Fruit St, Boston, MA 02114; Harvard Medical School, Boston; and the Center for Integration of Medicine and Innovative Technology, Boston. Received August 31, 1999; revision requested October 21; revision received November 19; accepted December 17. Supported in part by a grant from the Center for Innovative Minimally Invasive Therapy, a nonprofit consortium consisting of Massachusetts General Hospital, Brigham and Women’s Hospital, Massachusetts Institute of Technology, and Draper Laboratory. Address correspondence to the author (e-mail: smith.john@mgh.harvard.edu).
Abstract
Today’s radiology community depends heavily on cutting-edge diagnostic and therapeutic medical devices to serve patients. These products are regulated by the U.S. Food and Drug Administration (FDA) under a system that grants marketing approval for only those indications for which the safety and effectiveness have been established. Although this complex system is the result of a societal decision to ensure device safety and effectiveness, it has the potential to delay product marketing and impede innovation. Medical device regulation recently has undergone major changes with the enactment of the Food and Drug Administration Modernization Act of 1997 (FDAMA), legislation that is intended to increase system efficiency while retaining the requirement of safety and effectiveness. However, many of the envisioned improvements cannot occur without cooperative interaction between stakeholders in the device development process, including the FDA and the clinical medicine community. The radiology field must continue to build on its strong history of productive dialogue with the FDA to transform the legislative vision of FDAMA into regulatory reality. Such action will ensure timely access to the new device technologies that are necessary for the growth of our specialty and the effective care of our patients.
OT --- yes, me too, i was there in those days, as goldcoast_wpb... if you were a yahooligan you'll remember charon, gprewitt, corstrat, jrm (jim and kermit), scooterpass, bopper, fats, and the gang... it was gprewitt's "move" that got us such good press in the financial news outlets.
yes, when at thestreet.com... she wrote objectively in regard to outing "vulture" bond holders who tried to sink the good ship healthsouth after it's debacle with richard scrushy. these bondholders bought after the "news" and resultant stock price crash. the turnaround team played hardball with those so called vultures.
i have read good stuff from her before -- but, i concur, it read like a junior high school kid wrote it...
here's an interesting link to ge's news on c-arm sells.
i would like to highlight this...
"Normal shipments during the same time period generally range from 1500 to 1700 units."
http://www.genewscenter.com/content/detail.aspx?releaseid=9145&newsareaid=2
now, as the pr goes on to explain OEC was "on hold" per the FDA coming down on them...
we were effected by that, as we had to wait to get some insights on some things being contemplated... OEC wasn't even allowed really to discuss stuff... for example, we were interested in learning more about a digital subtraction imaging upgrade.
i posted on what "digital subtraction" is via one of my posts in a series on image resolution about 2 weeks ago...even with a youtube vid to show you...
it is my understanding that the DViS will/can be equipped with the software for such... as it's customized to meet consumer needs...etc. again, now think about this stuff in 3d realtime...
but, i digress...
the 1,500 to 1,700 per annum doen't include those sold by philips, siemans, ziehm.
29 November 2009
GE Healthcare Delivers More Than 2,000 OEC Mobile C-Arm Fluoroscopic Imaging Systems Total number is nearly twice the volume delivered in the same amount of time in prior 30-year history; includes 13 configurations across general surgical, vascular and orthopedic applications
CHICAGO, ILLINOIS – November 29, 2009 – GE Healthcare, a $17 billion unit of General Electric Company (NYSE: GE), announced today that it has shipped more than 2,300 units of the OEC® 9900 Elite C-arm mobile fluoroscopic imaging systems in the U.S. over the past 18-month period. According to the business unit, the shipment dates extend from June 1, 2008 through October 3, 2009. Normal shipments during the same time period generally range from 1500 to 1700 units.
A C-arm uses fluoroscopic x-rays to produce a 'live' image feed displayed on monitors during a wide range of surgical procedures. For more than three decades, GE Healthcare has been a leader in mobile C-arm surgical imaging with 7 out of 10 surgeons choosing GE systems to help them visualize internal body structures during surgery.
Customers Waited
Nearly three years ago, the future of GE’s Surgery business unit was in jeopardy as a consent decree with the FDA prohibited the business from manufacturing or distributing OEC surgical equipment to customers until quality system processes were improved to meet FDA standards. Remarkably, hundreds of OEC C-arm customers who wanted an OEC C-arm made the decision to wait. When the Surgery business unit resumed shipping in May 2008, more than 300 systems were delivered in the first 10 days. “Some customers placed orders for an OEC system prior to our stoppage, and many preferred to wait. Some waited more than two years for an OEC system rather than purchase one from an alternative vendor,” said Pete McCabe, President of GE Healthcare Surgery. “Our customers expect more and know that GE can fulfill their specific imaging needs.”
Cottage Hospital in Woodsville, New Hampshire purchased an OEC 9900 Elite in 2006, before shipping stopped. As the Director of Radiology for this 25-bed critical access hospital, Marcy Rushford (BS, RDMS, RTRM) and her staff desperately needed a new C-arm and had to make a tough decision. “We had a lot of faith in the OEC products and were willing to wait – which was really hard especially towards the end,” says Rushford. “But now I’m so glad that we did. The technologists love it and seem to have a lot more confidence especially in difficult cases. And the surgeons continue to comment on the phenomenal images they are getting from the OEC 9900 Elite.”
Surgical Solutions
GE’s OEC family of products provide superb fluoroscopic X-ray images in general, orthopedic, cardiac, vascular and urologic surgical procedures. The time, resources and expertise invested have elevated the quality and reliability of the OEC products, with the 9900 Elite’s uptime during testing increased to 98 percent. A dedicated group of 200 service engineers and 60 clinical application specialists are committed to ensuring that every OEC system’s performance is maximized through world-class service and customer-recommended service training and support programs.
The GE Healthcare Image Intensifier (II) technology helps healthcare professionals capture clear, accurate surgical images in both large and small patients during most surgical procedures. OEC systems’ II technology offers a Detective Quantum Efficiency (DQE) rating - the rating used to measure image quality - consistently at 65 percent, even in dense anatomy cases.
McCabe is proud of OEC’s progress and is encouraged by the ability of the business to deliver systems to so many customers during tough economic times. “Our customers know that the quality fluoroscopic mobile imaging provided by GE can positively impact patient outcomes, while reliability and support can impact productivity and maximize their investment.” He adds that the business is expanding, a development made possible by proven customer loyalty and the backing of GE and GE Healthcare. “We have a plan for growth, both in the U.S. and globally, that will help ensure that more facilities have access to the high quality imaging they need to be able to provide the best patient care,” said McCabe.
Hm -- and all... first, my thanks to those who have traveled to RSNA... again, wish i could've been there...
now, a little help here...
the world of high finance is not my specialty...
but, please any comments, etc., sought and appreciated...
my idea here is to do the back of the napkin math on some numbers, nothing more nothing less...
if up 1000 by 3rd or 4th year...
$550,000.00 x 1000 = $550,000,000.00
now take 45% on profit margin and you get...
$550,000,000.00 x .45 = $247,500,000.00
now divide by 400,000,000 shares (rounded up)...
and you obtain...
0.61875 cents
multipy by a 20 p/e... and you obtain...
$12.375 per share.
is this an exceptable way to approach this...?
particularly, if there is financing via some m&a...
supercleetus is a good guy... he helped me on another stock which had to do with ultrasound imaging, by his insights... that is what he was referring to...
your second link...
they mentioned the LODOX Statscan... just a little history... that thing was developed by the South African diamond mine industry to check workers to make sure they weren't stealing the diamonds on their way home... it does a whole body scan with very little dose... like less than a chest x-ray or something... it uses a pencil beam/cone beam... it's radiography...
it got plugged into the Maryland area emergency centers...called Shock Trauma... i think...
but hasn't really made headway the last i knew.
just thought you guys might find that interesting...
hi joe/superc/frank/pablo et al... i've been a busy bee this long weekend... i have just uploaded a revised manuscript for an article submission on radiation exposure... and also, we finalized our posters and had them sent ahead of time to our symposium starting later this week.
i will have limited time to check in/post on the board this week... (but will be lurking to catch any updates)... the only day i could've went to RSNA would've been today... with dean we are all in good hands though. :)
frank, getting back to that question on penetrating power, you're pretty much correct in your thinking... such a scenario may possibly mean "exploratory" sugery, in my opinion.
pablo, i've posted somewhere a link which discusses the whole CT radiation dose thing that Cedars went through -- it is a podcast via the american society of neuroradiologists (i think), but it is via their journal cite... the podcast link is probably still current... but it is technical... i really only mention it to state that yes while pediatric dose is always a big topic, the whole topic of CT dose, with the Cedars thing as you can imagine, will be even more front page at this year's RSNA i'm sure...
hey, superc, good to hear from ya...
quick post...no, the aquilion isn't portable, but there are portable ct scanners...most of the them are head ct oriented...ceretom is most well-known...
frank and others my thoughts on bariatric patients...
i am actually going to use this reference in one of my presentations next week...
http://radiology.rsna.org/content/252/1/128.abstract
but with respect to imaging via CT or MR...
currently, open MRs exist as does "open" bore MRI... open MRs don't have the circular ring/bore and are typically low-field strength (something around 1.0 or less Telsa, but typically anything at or less than 1.5 T is considered low field)...although some manufacturer (i forget is bringing out a high-field open)... "Open" bore MRs are just larger bores...for these, seimen's accomodates up to 450 lbs. apparently.
i prefer closed MRs or "open" bore MRs, in my opinion, unless your claustrophobic and don't want to be knocked out for the exam.
regarding CTs and for that matter the DViS...i was impressed with the perspective offered by the latest picture on the website... what impressed me was the open-ness of the DViS gantry...
nevertheless, i would be cautious to think that the CT aspect of the DViS would image a bariatric patient sufficiently...but, i dunno...
generally speaking: c-arm fluoroscopic x-ray tubes are designed for low "power" (a good choice of word, i use it to describe it to laypeople) over long time, relatively speaking. it's the nature of the business... however, they can put out up to ~300 milliamperage (mA, or a component of your "power"), used for what are called spot films, however, most mobile units don't have the spot film feature.
that means that you still have the issue of being able to penetrate appropriately a bariatric patient...
c-arms units do have what is called "boost," which automatically doubles the mA with the touch of a button, but this is only practical for up to so big of a sized patient...
going back to diagnostic stuff, a lot of times, you'll see radiology reports state that because of body habitus, the image is unconclusive or something like that...
now, a last point in my not very organized post, because the DViS has the CT feature... the tube is probably, "'better' than your average c-arm tube."
just random thoughts, gotta run...
i just saved the new picture to my pc, and made it my desktop background...use the stretch option and it fits perfectly...sorta coool to see it enlarged.
new picture of DViS (with "patient" inside the gantry), and a new style-lized workstation/cart are on the homepage of IMGG... actually, even the base and arms of the gantry are newly style-lized...
looks like *high quality* to me...i wonder if this is what a production model might look like...
http://www.imaging3.com/State_of_Company...
asterisks added by me for emphasis...
The Dominion Volumetric Imaging Scanner, the DViS, is a patented breakthrough mobile fluoroscopy technology that produces *high quality* 3D images in real-time. It is the only product in existence that can produce a combination of *high quality* 2D, 3D real-time, and CT imagery in a single device. The unique engineering design accomplishes these capabilities while dramatically reducing exposure to radiation, and providing a small, mobile footprint for easy transport, all at a cost of about one third of existing CT devices
look here to see what the earlier version of the cart and gantry base looked like...
http://www.imaging3.com/photo5_imaging3dominion.html
can anyone say, Road to RSNA.
joe, did you happen to catch my post about the video animations on CT...
specifically it was directed to sonomawest but to all also...
i think i posted it like at 5am today... so click my moniker and search my posts...
my thoughts after watching it...
i was excited because i was dreaming about the "what if's."
like we own the intellectual property of 3d real-time... including but specifically related to medical imaging...it's what the DViS is all about...right...
i was thinking about our technology integrated with say the high-technological nano-detector system that Philips' uses for their CT scanner as shown by the animation...
or what if that type of technology was put into the DViS detector plate...
that is what i would like to see down the road...i.e., if such "deals" are struck, etc. etc.