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exactly. sorry I never specified what I was trying to point out. There are a few other things in the release that can be gleamed from this approval as well. good luck to all. package perfect, step by step, issue by issue=patience.
FDA NEWS RELEASE
For Immediate Release: Feb. 11, 2011
Media Inquiries: Erica Jefferson, 301-796-4988 , erica.jefferson@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves first 3-D mammography imaging system
Selenia Dimensions System may boost accuracy in breast cancer detection, diagnosis
The U.S. Food and Drug Administration today approved the Selenia Dimensions System, the first X-ray mammography device that provides three-dimensional (3-D) images of the breast for breast cancer screening and diagnosis.
A mammogram is a safe, low-dose X-ray of the breast that is the best tool for early detection of breast cancer. However, with the limitations of conventional two-dimensional (2-D) imaging, about 10 percent of women undergo additional testing after the initial screening exam for abnormalities that are later determined to be noncancerous.
The Selenia Dimensions System, an upgrade to Hologic’s existing FDA-approved 2-D system, can provide 2-D and 3-D X-ray images of the breasts. The 3-D images may help physicians more accurately detect and diagnose breast cancer.
“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The National Cancer Institute recommends women ages 40 and older have a mammogram every one to two years. Nearly 40 million mammograms are performed each year in the United States.
As part of the approval process, the FDA reviewed results from two studies where board-certified radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone.
While the combination of the Selenia’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having both a 2-D and 3-D exam is expected to be less than 1.5 percent compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography.
The Mammography Quality Standards Act requires that all health care professionals obtain eight hours of training prior to using new mammography technology on patients. The FDA also requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic, and yearly quality control measures.
According to the NCI, nearly 200,000 women will be diagnosed with breast cancer this year. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.
The Selenia Dimensions System is marketed by Bedford, Mass.-based Hologic Inc.
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ofcourse it could and did sano. i commend you for using your foi right. whether this needs to be kept secret due to reasons we can only surmise, the fact is we now know the exact issues to be worked on; with this, we can fully expect a clear direction and the ultimate results and corresponding timelines (approx. ofcourse)
once again, thk u for forcing the hand of i3 for the transparency WE SO DESERVE
BRAVO
thanks sano
wow. lots of housekeeping.....i am hoping all can andd will be resolved in time. dang
"Mr. Cohen spent more than 17 years in senior FDA regulatory positions, including as Deputy and Acting Director, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, and as Associate Chief Counsel for Enforcement, Drugs, and Biologics. He joins McDermott from the Washington office of a national law firm." end quote
we will soon know if Dean (all of us)is sweet dreaming or not. Would he really bring his shell to this man's division?
wow. HEAVY HITTER IS CORRECT. good luck to everyone, even the traders.
GOOD BUY KIMBLE.
Bust understands the situation. I prefer real people, real consultants to those that have no real effect on the outcome of this ground breaking machine.
Bust is and was a major supporter developer of the confidence of this board, however, the real life lawyers and consultants that will move this forward can ACTUALLY DO SOMETHING ABOUT THIS.
who knows, maybe bust is one of those real people.
Thanks bust, isguru, mugs, benny, hubris etc
if you are real or not, you helped out. thanks.
this is a great step for what we have on our plate; i wish i wouldve seen the value @7cents. gl2all
Actually, that is great!
Dean getting professional help is what is best.....CORRECT?????????
Well Shaka, we got our answer. Yes, it will be ugly today. I'm not sure how this will shake out, but if I was willing to invest alot of money (for me), I will have to keep hoping the dominion makes it to market.
Today the stock stopped aging me. Out of limbo, is better than having no direction at all.
GOOD LUCK TO ALL
Just putting to rest that they will need capital to get through next year. It's only 1.2% of the o/s, give or take.
Bad timing.....maybe.
or it could just be the best headfake ever. So 1 million dollars to get through next year. Timing doesn't always have to be against you.
let's go FDA!!!!!!!!!!!!!!!!!!!!!!!!!!
how do you know???
care to divulge that info?
unfortunately, or fortunately, I am an all in type of guy. no sitting on the outside looking in. I want to be in the game from the start, so I have made my bed, and I will lay down in it.
I have added since the start, only because if I have come this far, I might as well add to get my number; I guess that number is 20,000 shares.
.....it's no 2 million like some people here.
then I would release a few and swing. but my number doesn't match with my wishes (i.e 2 million). so i sit and wait like the rest of the buy and hold crew. gl2all
wow. chill a bit, and remember why you laid down those dollars on this company. patience my friend.
No offense, but I read your email to them that you posted. Awhile back someone said if you word it professional and actually provide more than 1 sentence, you might just get a response...I'm just sayin'. These people cannot answer to everyone, and their policies might even be in violation if they answer certain questions.
I just thought maybe that was why you did not receive an answer. good luck to you for sure.
hence, why ultimately the 2+ years. early days, inefficient review team. start clock over. re-read 2 Benny's four post ago. wait it out people; ignore all rehashes pertaining to these solid facts. thanks BennyJ!
this is great dd. skepticism aside, this should be top posted no doubt.
remember, if it is that good it can become the predicate. how else does technology evolve. =new predicates.
asking for the % gain is a bit much, but I definitely agree about the amazing news attention.
Lets go FDA! can't rush a good thing I guess. If there was not a new review team I would not feel this good, albeit cautiously optimistic.
We soon will know if we need more tweaks, or hoops to jump through.
The waiting is the hardest part-Tom Petty
sheer public/investor skepticism, and let's not forget the lack of knowledge of the average joe.
once this gets approved, here come the biggest and best marketable stages of the dominion known possible. we are going to be saving lives more efficiently, and safer than any other company/product.
cha ching!
thanks for the d.d
nice to read that document and picture the dvis going through the motions. I still think this will take a little longer as we are going to be the new predicate!
i say sept 9th for the 150 (adding 5 calendar days to receive package, then tallying up to the 150), but accounting for minor pauses I would say no more than September 17th to give this new review team 100% for meeting their 150 day response time objective.
This is a great time to be an imgg shareholder, as we are possibly going to enter a whole new echelon of the company life cycle in the not so distant future.
Thing is, I don't think the company imgg, as we know it, will ever get to see it's training wheels come off.
Cheers to deep pockets and good luck to all!!!
BOO Yah!
Just doing some reading and awhile ago there were some concerns (some would say ALOT of concerns) whether the Dvis fit into a predicate slot behind some other similar device.
Talk was that because this is so revolutionary that the FDA would have trouble ultimately matching it, and ultimately approving it for market.
read this from the link from the fda website I just posted earlier
"The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate." Although devices recently cleared under 510(k) are often selected as the predicate to which equivalence is claimed, any legally marketed device may be used as a predicate."
will the Dvis BE THE STANDARD PREDICATE and that maybe is why this is taking so long because the template and fine tuning has to be set. this is a great thing to read.
gl2all
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm224401.htm
accountability measures
upon clearance of this device, 50 million volume if announced at the start of the day maybe...
definitely a GAP^^^^ if announced after the bell.
a pull back or not, this will move as we magnet towards that 150 time horizon. bring on September.
I hate chasing this, but i had to call this bugger in. 47.5
now done and done >20,000. gl2all
Serious Volume....
Check the volume in the past major run-up. 40 milly+
I wish I had the kahunas to sink more $ in @ .16
18,000 shares and holding...
small, in comparison to others, but a huge bet for me with my dca.
If I could have discovered this gem back in the .10 days I would have 180,000 of those coveted beauties.
That is just the way things go. Learn from it.
good for you, if you feel this train is gonna slow down into September.
so much for .24 Shaka. gl2all!
Why not?
Those who don't want to buy into this ride @30 can now do it at 24.
a 20% discount.
like the guy says.....what is the share price indicative of right now anyway. Everything is in the hands (for the most part) of the FDA....oh, and the day traders.
This might be your last chance to hit that valley before the pending outcome. Isn't that what you were waiting for?
no doubt...
the timeline, if all holds well with the "no public requests for additional info" can't be ignored with the new review team.
then it is a question of which side of the fence are u on? The non-believers are sure putting alot of negative energy into this. I'm asking myself why? but we all no why!!!!!!!!!!!!!!!!!!
we will see, hopefully, one way or another in the next 30 days imho.
good luck.
The bashers are sure on it today. Wow. This will all play out soon, so all this rekindled caustic dribble is laughable, yet so weak.