is lurking...
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
It's not a 2 year old SEC filing...
http://ih.advfn.com/p.php?pid=news&symbol=IMGG&selsrc[0]=edgar
This SEC filing was done 06/01/2010 at 5:36 p.m. It appears to be notification of two transactions that were not recorded back in December, 2008. The amounts and pricing are consistent to that period of time.
Just a thought... but I find it interesting that this filing is being made 1 1/2 years later. Wonder if some sort of audit/due diligence has revealed the prior inconsistency? Hmmm...
hh,
Here's the video/article link to last night's Dallas TV news item concerning radiation exposure...
http://www.wfaa.com/news/health/Safety-Concerns-about-Medical-Imaging-94857154.html
Safety concerns about medical imaging
by JANET ST. JAMES
WFAA
Posted on May 25, 2010 at 11:23 PM
Updated yesterday at 11:28 PM
Medical imaging, including X-rays and CT scans, let doctors see what's happening inside the body in great detail. More than 70 million such images are snapped annually, often with life-saving results.
But, with newer technologies, have come more powerful doses of radiation.
There are now growing concerns over safety.
Fran Gosnell is basically home-bound because of permanent internal injuries from cervical cancer treatment.
"Too much radiation," she explains, "And it wasn't regulated as it should have been."
Gosnell says her bladder, colon, and a major vein were damaged by radiation, more powerful than it was supposed to be.
In high therapeutic doses, experts know there is increased risk of dangerous side-effects.
But now, the FDA is investigating overdoses from diagnostic radiation. Diagnostic radiation is the same energy used in mammograms and X-rays.
In Los Angeles, more than 300 patients suffered radiation poisoning, after having CT scans.
"The effects won't show up for 20 years," says one victim. "I'm only 51. That means what I'll start having problems at age 70?"
There is very little oversight of radiation dosing. A facility typically monitors its own machines.
Experts say a single session in a CT scanner is like having 400 X-rays.
While one scan isn't a worry, multiple scans in a short period of time for some people, might be.
"There is a great potential for over-exposure to radiation, specifically in CT," says Texas Health Dallas medical physicist Messica Clements. "Exposure to radiation can increase your chance of cancer by 1 percent. So one in every 100 people could have an increased chance."
Clements monitors the scanners at Texas Health Dallas for accurate dosing to make sure patients aren't exposed to any more radiation than absolutely necessary.
In fact, medical radiation may cause 29,000 new cancers a year and 14,500 deaths, according to research published in the Archives of Internal Medicine.
Young people are at highest risk, partly because they have many years ahead to develop disease. Larger patients also have higher risk because more radiation is required to image their internal organs.
Doctors say short of radiation poisoning, which can result in lost hair and visible burns, there's no way for a person to know when they've been exposed to too much radiation.
"Much of the work on radiation sickness, radiation dosage, actually came on studies right after the second world war, related to the atomic bomb blast," explains Baylor radiologist Mark Fulmer. "Extrapolating data from an atomic bomb explosion to having your yearly chest X-ray in your doctor's office is kind of a hard, or not necessarily the right parallel to draw."
The best way to calculate even theoretical risks, say radiologists, is to compare imaging doses to radiation people soak up every day from the sun.
According to the FDA, a chest X-ray has the equivalent of 10 days of ordinary background radiation, a mammogram, three months.
An abdominal CT scan is like three years.
Despite that, radiologists say patients are often demanding.
"Radiation is always brought up," says Texas Health Dallas radiologist Dr. Douglas Baker, "And you still have some patients who insist on having exams done."
The potential for side effects is so real that North Texas medical centers are spending millions on new technologies that reduce exposure.
At Texas Health Dallas, there's a Flash CT, which scans faster and with less radiation.
Baylor Medical Center has a radiation safety committee.
"We presume that we might be inducing cancers from CT," says Baylor medical physicist Angela Bruner. "We're not sure yet, it depends on how it hits the body, but we want to do the right thing now to reduce that, so we formed this committee to do so."
For those who are worried, doctors suggest patients keep medical records of prior scans and ask questions before agreeing to medical imaging that might not be necessary.
"It's important that patients discuss this with their doctor," says Dr. Baker, "Ask, 'Why is this exam being performed? How is the information from the exam going to improve their health care? Are there alternative exams that don't require radiation, such as an MRI or ultrasound that can be performed instead?'"
There is no doubt that radiation for imaging and treatment can be lifesaving.
For Fran Gosnell, it has also been life-altering.
"I want them to be very aware of what they're getting into," says Gosnell, who wants others to hear her warning and know that what you can't see, can hurt you.
E-mail: jstames@wfaa.com
Thanks. I'm not sure why more 3D images were not made available from the company. Who knows, Dean may have realized he was providing too much information on the DViS at the RSNA 2008 and placed proprietary restrictions?
---
You bring up another point. With boardmarks on the rise, I believe Mods should update some of the ibox information for all to have quick access to company information.
I think we should replace old press releases with recent pertinent press releases, replace RSNA 2008 photos with RSNA 2009 photos/video, remove the Dominion Prototype photos, remove the Oregon Health Luminary info and update the Share Structure. tia
The DViS 3D Orthographic Perspective Image was taken from the company website and placed in the ibox...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=33897655
The 12/01/08 Press Release referred to the new imagery and the RSNA...
http://www.marketwire.com/press-release/Imaging3-CEO-Opens-RSNA-2008-Conference-With-New-Images-Interview-With-Leading-Trade-925353.htm
'Mr. Janes added, "We are very pleased by the response that we have received for our newest version of the DViS 3D Orthographic Perspective Interface Software and the new imagery that was unveiled today. The reaction of doctors and other radiology professionals to our new images and future product plans was all positive and we are very happy with the way our technology has been received."
"The images that were shown today at RSNA will be available for viewing on the company's web site, www.imaging3.com, mid-day on Monday, December 1, 2008," stated Mr. Janes...'
I think you're right about Mineseeker...
Makes me wonder about the size and scope of this operation?
---------
John L. Evans has been a Director at Mineseeker since November 2005...
http://uk.linkedin.com/in/johnevans
Current
•Commercial Consultant at COLT Telecom
•Managing Director at One-Fuel Limited
•Director at Diamined Limited
•Moderator / Founder Member at LION™ - The Authentic & Original Open Network™
•Director at The Mineseeker Foundation
•Founder / Director at LinkedInterims™
•Managing Director at LOCRIS
---
John L. Evans’s Experience
Director
The Mineseeker Foundation
(Non-Profit Organization Management industry)
November 2005 — Present (4 years 6 months)
LinkedIn Group: http://www.linkedin.com/e/gis/21041/38609C524E5C
The Sole of Africa:
http://www.linkedin.com/e/gis/21042/450D78701E23
Not-for-profit committed to improvement in technology for humanitarian mine action to reduce the social and economic impact of landmines.
Populations are denied land for agriculture, access to water, health care and communications in more than 70 countries where landmines threaten life and promote fear. The economic and social costs are incalculable.
The MINESEEKER Airship fitted with unique ground penetrating radar detects plastic and metal landmines infinitely faster, more safely and cost effectively than any other method. Its scanning capacity is 100 square metres/second (manual demining 40 metres/day).
Promote and improve technology and develop an effective airship mounted landmine detection system - fast, accurate minefield mapping, allowing conventional de-mining to be concentrated where it is needed.
---------
Managing Director
LOCRIS
(Privately Held; 1-10 employees; Management Consulting industry)
April 1987 — Present (23 years 1 month)
http://www.locris.com Tel: +44 (0) 7957 190186
We specialise in delivering commercial programmes, leveraging purchasing power and resolving difficulties primarily (but not exclusively) in ICT.
Problems of projects, programmes or departments out of control or failing, supplier or 3rd party relationships becoming difficult, contract disputes, or fundamental mismanagement - LOCRIS can fix it.
Managing Director - LOCRIS Limited - Interim Professional Services to 3rd parties: specialising in business efficiency and the exploitation of ICT for business benefit.
Innovative application of mature ICT technologies and novel marketing strategies to create a world beating service to overcome every day business issues.
Identify and recruit Executive.
Secure Enterprise funded support, develop and implement investment readiness plans, identify and solicit technology and marketing partners, identify and solicit channel partners.
---
http://www.xing.com/profile/JohnL_Evans
The new venture is listed with Nevada SOS and the "List of Officers" is due June 30, 2010...
http://nvsos.gov/sosentitysearch/CorpDetails.aspx?lx8nvq=AS6js1%252f07XdhcD7wVJcnpQ%253d%253d&nt7=0
http://www.sec.gov/investor/pubs/rule144.htm
"If the company that issued the securities is subject to the reporting requirements of the Securities Exchange Act of 1934, then you must hold the securities for at least six months. If the issuer of the securities is not subject to the reporting requirements, then you must hold the securities for at least one year. The relevant holding period begins when the securities were bought and fully paid for. The holding period only applies to restricted securities..."
Holding period for restricted IMGG stock is six months.
Here's a couple of postings/links from Feb 2009 regarding the Medtronic O-Arm. The links include Dean's take on the subject...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=35253877
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=35254393
---------
Also, check this Dec 2008 PDF report from OR Manager indicating the higher costs associated with the Medtronic product. The report makes a couple of references to Imaging3's DVIS...
http://www.hayesinc.com/hayes/uploads/2008/12/ormvol24no12oscanner.pdf
"The technology is expensive at nearly $1 million for the O-Arm and Stealth together,and $20,000 should be added for marketing and education, Blatnik advises. Minimally invasive instrumentation will add another $89,000 to the price, in addition to disposables such as percutaneous leads and dilating tubes. A reusable set of dilating tubes is about $20,000..."
Company made a very good move by filing the 10K late... it postpones the SEC Filing by an additional 15 days from 03/31/2010.
http://www.sec.gov/answers/form10k.htm
---------
The company now has the opportunity to complete and submit the FDA package by April 5th.
It seems logical to me that the company has prioritized these two events.
jmo
Notification that Annual Report will be submitted late (NT 10-K)
http://ih.advfn.com/p.php?pid=nmona&cb=1269953627&article=42183292&symbol=NB%5EIMGG
DOTmed Video Profile: Dean Janes of Imaging3
Dean Janes gives very good description of a sharp looking Dominion at the RSNA 2009...
http://www.dotmed.com/news/story/11767/
Here's a post from Dean pointing out the difficulty of achieving real-time 3D via conventional CT...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=27290613
"Great question... It really isn't possible to retrofit their scanners to provide real time 3D imaging. The reason has to do with why it is virtually impossible to perform 3D real time imaging from a conventional CT device and that is fulcrum slice imaging. These slices are, for a lack of a better term, shaved slices which are about .5 to 1mm thin. You have to stack them on top of each other to build a 3D model. This takes way too much time and uses serious computer power, which greatly limit its speed. The increased speed of these new CT scanners means they can acquire these slices faster, but no where near as fast as the imagery we acquire and display. Licensing is definitely a potential for our technology, but I think being acquired is more realistic as one of the big boys wouldn't want this technology to be accessible to their competition...
Dean"
---------
Based on what Dean is saying here... I believe the "serious computer power" needed to attempt real-time 3D with CT would also make it difficult to obtain portability.
(jmo)
It sure is interesting that a CEO would comment about a certain kind of ordinary investors who worried about the company...
“Good riddance!” he declared. “We’re better off getting rid of that type of fickle investor in the first place.”
However, it does remind me of another statement Dean made in a post...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=42430090
"We in management have always tried to provide an open book for investors, recently I started having conference calls to update you on our progress, especially with the FDA. This latest dilution was not mentioned as we had yet to file the 8k. Dilution primarily hurts my position, it boggles my mind how people holding less than a million shares get so worked up about it. Google has over 300 million shares outstanding and it doesn't seem to affect their PPS. We opened this PPM to raise money as we even described in a previous CC, we sent a newsletter out to shareholders and many responded, this was when we were at 4 cents! The response was so huge we ended up having to decide whether to take more or turn money away. Ultimately, I think I made the right choice to take money in the worst economic times of my generations lifetime, especially since we won't need to raise any money in the future and can better position ourselves towards manufacturing once we get FDA approval..."
---------
I'm not sure "what kind of person would utter such nonsense," but CEO's should not be making negative statements about shareholders. Time will tell if this company "won't need to raise any money in the future."
There appear to be recent changes to the Alliance Acquisitions Inc. website. I didn't realize that both Dean Janes and Xavier Aguilera were part of this new "acquisitions" company...
http://www.alliance-acquisitions.com/about/
KEY MANAGEMENT BIOS
..."Dean Janes
Co-Chairman, President
Mr. Janes has been Chairman and CEO of Imaging 3, Inc. (OTCBB:IMGG) for 10 years, successfully taking the company from development-stage to publicly-trading entity. Mr. Janes is the principal inventor of Imaging 3’s real time 3D medical diagnostic imaging technology which received a patent in less than 18 months and is currently in final stages of FDA approval process. He has over 25 years of experience as a biomedical electronic engineer and he served for 9 years in the U.S. Army as a biomedical technician.
Mr. Janes’ work experience includes serving as a National Tech Support Engineer for Toshiba and Senior Engineer for Kaiser, COHR and OEC. He was responsible for integrating a CCD camera with a mobile fluoroscopy into the C-arm, a system that is used throughout the medical diagnostic medical imaging industry today. He majored in Bio-Medical Electronic Engineering at the University of Colorado Technical Institute. Mr. Janes is a member of MENSA and is listed in Who’s Who of Executive Business.
Xavier Aguilera
Chief Financial Officer
Mr. Aguilera has over 30 years of experience in finance, marketing, international finance and administration. Having served as both a domestic and international banker, his experience in administration has enabled him to help companies achieve high levels of success. For the past 7 years, Mr. Aguilera has been the Executive Vice President/CFO for Imaging 3, Inc. (OTCBB:IMGG), overseeing many early financing rounds for the company and all financial filings for the SEC.
For approximately 10 years prior to his employment by Imaging 3, Mr. Aguilera served as a consultant in the medical management field. He holds a Bachelors degree in Business from California State University at Northridge and a Certificate of Medical Management from the University of California at Los Angeles..."
---------
I wonder if Dean & Xavier have their own office space in Los Angeles?
Alliance Acquisitions, Inc.
11400 W. Olympic Blvd., #1400
Los Angeles, CA 90064
Stay tuned folks... there's probably some kind of explanation right around the corner...
It appears corrections were made to yesterday's Form 4 with an amended Form 4 issued today...
http://ih.advfn.com/p.php?pid=nmona&cb=1266974589&article=41689932&symbol=NB%5EIMGG
- Amended Statement of Changes in Beneficial Ownership (4/A)
Common Stock 2/12/2010 J (1) 2600000 D $0.71 59576328 D
Explanation of Responses:
( 1) Mr. Janes conveyed 2,600,000 shares to a lender in repayment of personal debt of $1,858,714.
---------
It will be interesting to see the 10-K towards end of next month...
Imaging3 also pays MoneyTV to continue that format... they also pay BlueWave Advisors, LLC; the parent of Stock Preacher...
It's my understanding that MoneyTV is cash only... not sure about BlueWave, which could be paid in IMGG shares...
(jmo)
It could be an Off-Shore Hedge Fund...
Or, you may want to check with NITE with well over 1/2 billion ZENG shares served in 2009... they may have an answer to your problem.
ZENG Monthly Share Volume Report
http://www.otcbb.com/asp/tradeact_mv.asp?SearchBy=issue&Issue=ZENG&SortBy=volume&Month=12-1-2009&IMAGE1.x=20&IMAGE1.y=8
NITE
Knight Equity Markets, L.P.
December 2009 November 2009 Year-to-Date
Volume Rank % Volume Rank % Volume Rank %
106,970,060 1 68 31,600,024 1 69 608,086,109 1 54
_____________________________________________________________________
You're quite welcome.
I noticed a post on 2/17 pointing out that ZENG was taking a beating... no wonder... two-thirds of the volume was shorted on that day.
ZENG Short Volume and Daily Volume for February 2010:
http://regsho.finra.org/regsho-February.html
February 2010 Reg SHO Daily Files (ORF)
Pursuant to a Securities and Exchange Commission request, FINRA has agreed to make reported short sale trade data publicly available. Daily Short Sale Volume File
Date|Symbol|ShortVolume|TotalVolume|Market
20100218|ZENG|1238644|2688094|O
20100217|ZENG|4781679|6943439|O
20100216|ZENG|224300|356932|O
20100212|ZENG|80000|540500|O
20100211|ZENG|53500|238700|O
20100210|ZENG|482325|659199|O
20100209|ZENG|335000|494000|O
20100208|ZENG|420300|1107701|O
20100205|ZENG|139710|584350|O
20100204|ZENG|391225|1757825|O
20100203|ZENG|564300|1643300|O
20100202|ZENG|66250|762891|O
20100201
http://www.reuters.com/article/idUSTRE61H6CR20100218
FDA staff say agency may need new device powers
WASHINGTON (Reuters) - U.S. Food and Drug Administration staff said they face difficulties in reviewing certain medical devices, hurdles that may call for additional regulations and authorities, even as the industry defended the current approval process.
Health
At a public meeting Thursday, held to discuss possible changes to the FDA's device program, agency staff said it is difficult to weigh new products under the accelerated review process used for products similar to those already approved.
It can be hard to tell if a new device is truly similar to an approved product or if there are enough differences to classify it as an entirely new product, they said. Difficulty inspecting devicemakers and a high number of proposed new products are also an issue.
"Developing clear definitions, guidance and additional authorities may be required," said Heather Rosecrans, director of the FDA office that oversees such reviews, known as 510(k).
Devicemakers, industry consultants and investors said some smaller changes could improve the current process. They cautioned that a major overhaul could stifle innovation and prevent newer technologies from reaching patients and doctors.
FDA is weighing potential changes to the way it evaluates medical devices after a number of high-profile safety problems with heart defibrillators, contact lens solution and other products raised public concerns. Critics say the accelerated process is used too widely and can lead to problems after devices are sold.
Devicemakers are worried they could see longer review times, higher costs and other hurdles that may make it harder to get their products on the U.S. market. The threat of greater regulation affects smaller manufacturers as well as larger ones such as General Electric's GE Healthcare and Siemens AG's Siemens Healthcare.
Unlike traditional new drug and device applications, 510(k) reviews do not necessarily require clinical data on use of the device in patients. Just 8 percent to 10 percent of expedited device applications have patient data, FDA staff said.
Agency officials have said the meeting will help inform an internal task force charged with highlighting changes the agency can make with existing powers. An outside report from the Institute of Medicine, due next year, will focus more broadly on the FDA's device division and what additional power or changes it needs.
Industry representatives were heavily represented at the meeting, something noted by the few practicing physicians and consumer advocates who also spoke.
Mark Leahey, president and CEO of the Medical Device Manufacturers Association, called the 510(k) process "one of the great successes" of the FDA, noting that "There are always areas for improvement."
FDA staff said most devices are recalled because of manufacturing or design problems, something Medtronic Inc Senior Vice President Susan Alpert said would not change even if the agency implemented changes to the approval process.
The FDA could issue more guidelines for companies to follow and focus more on staff training, other industry experts said.
Diana Zuckerman, the only consumer advocate to speak at the meeting, said newer, slightly different products are not necessarily better for consumers and can sometimes cause injury and death. She cited recent problems with Baxter's infusion pumps and massive recalls in 2007 of contact lens solution by Advanced Medical Optics, now part of Abbott Laboratories.
"In many cases these innovative devices are either not as safe as other products on the market, or not as effective," said Zuckerman, president of the research and advocacy group National Research Center for Women & Families.
FDA officials have said they will accept public comments for the next month before making its task force's recommendations public in June.
The meeting is part of the agency's broader reevaluation of its device division under the Obama administration. After the meeting, Jeffrey Shuren, the new head of FDA's Center for Devices and Radiological Health, said the agency could make some changes before the IOM releases its report next year.
Any substantial new FDA authority over devices would require action by Congress.
(Reporting by Susan Heavey; Editing by Tim Dobbyn)
That's your opinion...
The article covers possible changes to the FDA review process, which involves all medical devices; including the Dominion.
Imaging3 has had the Dominion under FDA scrutiny for well over 2 1/2 years... any changes in the FDA's approval process will certainly affect the company and its shareholders.
Articles found in the area of medical devices is definitely on-topic and should be posted. Anyone investing in this company, or any other medical device company, should have access to this FDA information.
Here's another article from the Star Tribune regarding concerns over the FDA's probable changes to its medical devices review process...
http://www.startribune.com/business/84521802.html?elr=KArksLckD8EQDUoaEyqyP4O:DW3ckUiD3aPc:_Yyc:aUUsZ
Med-tech group to discuss FDA's 510k process
Med-tech execs say changes are ill-advised
Last update: February 17, 2010 - 10:00 AM
A group of top guns from Minnesota's medical device industry will gather Wednesday to discuss the prospect that the U.S. Food and Drug Administration (FDA) is about to tighten its scrutiny of new medical products.
The newly formed Minnesota Medical Device Alliance will host a panel discussion about the FDA's 510k program, which regulates medical devices. The 510k process, which accounts for the majority of medical device approvals, is under review by the influential Institute of Medicine, a policy research branch of the National Academy of Sciences.
In addition, recently named FDA Commissioner Margaret Hamburg has called for changes in the operation of the 510k program.
Critics contend that the program doesn't require enough clinical studies of devices before they are approved for use in humans.
Minnesota's medical device community is concerned that a tougher 510k process could hamper new research and the introduction of innovative medical devices.
A steering committee for today's event includes CEOs from several local start-up companies, device entrepreneurs, legal experts and venture capitalists.
The event is at HGA Architects & Engineers in Minneapolis, with a reception at 4 p.m. and a panel discussion at 4:30 p.m.
JANET MOORE
"Your title there is a little misleading."
You mean the title of the Wall Street Journal's article...
FDA Memo Hints at Curbs to Approval Process for Medical Devices
Well, there's nothing misleading in the writer's title regarding WSJ's access to an internal FDA memo. It has been documented in recent months that changes are coming to the FDA's medical device approval process. It's doubtful the FDA, or anyone else, really knows what those changes will be.
FDA Memo Hints at Curbs to Approval Process for Medical Devices
http://online.wsj.com/article/SB10001424052748704398804575071791464778482.html?mod=googlenews_wsj
FEBRUARY 17, 2010, 7:12 P.M. ET
By ALICIA MUNDY And JARED A. FAVOLE
WASHINGTON—The Food and Drug Administration may tighten or eliminate several pathways for getting a medical device approved quickly amid concerns they have been overused by industry, according to an internal agency memo reviewed by The Wall Street Journal.
The proposals came in a Dec. 22 briefing involving officials in the FDA's device division.
According to the memo, officials questioned the increasing use of private companies that are hired by device makers to pre-review products. If the third party signs off on the device, the FDA may approve it without much further scrutiny. The memo notes the "Real value to industry may be that this is perceived as a way to 'sneak things in."'
Jeffrey Shuren, head of the FDA's device division, said in a statement that the Dec. 22 meeting discussed "initial findings" about possible changes.
The industry will have a chance to air its views at a public meeting Thursday. Dr. Shuren declined to discuss specific moves the FDA might make, saying he doesn't want to influence the meeting "by emphasizing any particular point that has been part of very preliminary staff discussions."
The FDA began a review of device approvals last fall after stories in The Wall Street Journal about a knee implant called Menaflex. The ReGen Biologics Inc. device was approved in late 2008 using a fast-track process called 510(k) over the objections of a half-dozen FDA scientists and managers during a four-year battle. The 510(k) process is designed for products that are similar to earlier devices, known as predicate devices.
The FDA report on the Menaflex decision noted that the 510(k) process was subject to abuse because in some cases the link between the new product and earlier devices was tenuous. More than 3,000 devices get approved through 510(k) annually.
Device company executives and industry analysts have said they expect regulations to tighten this year. The industry says the FDA shouldn't erect excessive barriers to innovative products. It says the 510(k) process is an effective way to get devices to patients quickly.
Analysts at Washington Analysis said in a research note, "The changes (to 510k) will undoubtedly increase the cost of device development, a clear advantage for larger companies."
In its memo, the FDA questioned how much leverage the agency has under existing law to demand more data from companies that use the 510(k) process.The notes say, "How do we deal with predicate devices after we decide to raise the bar?" and add that current regulations pose "challenges" for the FDA.
FDA officials said one option is to eliminate a program known as special 510(k), in which device makers can declare that their new device conforms to an earlier one they make except for a specific modification. This lets them get approval decisions within 30 days. The officials also discussed keeping the program while tightening the rules. The memo noted that roughly a quarter of all 510(k) approvals go through the specials program.
The memo noted that FDA reviewers often can't check the veracity of summaries made by companies in real time, and said that there had been at least one rescission of a special 510(k) device "based on false information."
The memo says the FDA also has concerns about abuses in its third-party review program. It says third-party reviewers often lack expertise and "often just repeat what is in the submission" from the device company without analyzing it. As a possible solution, the memo says the FDA may limit devices eligible for third-party reviews.
In fiscal year 2008, the FDA received 301 devices through the third-party program, up from 185 in 2003, according to its annual report.
In the memo, FDA officials acknowledge that there is confusion within the division about what approval standards to apply, and sometimes inconsistency in what is demanded of companies and how their products are judged. The industry has often complained that the FDA sends mixed signals about regulations to device makers.
The FDA's 510(k) working group has scheduled a briefing for device division employees on Feb. 24.
Write to Alicia Mundy at alicia.mundy@wsj.com and Jared A. Favole at jared.favole@wsj.com.
Geneva International Centre for Humanitarian Deming
http://www.gichd.org/links-information-database/overview/
Mineseeker & QinetiQ:
http://www.gichd.org/links-information-database/technologies/linksdb/projects/mineseeker/
http://www.gichd.org/links-information-database/organisations/linksdb/organisations/qinetiq/
Info links:
http://www.gichd.org/links-information-database/technologies/linksdb/technologies/multi-sensor/
http://www.gichd.org/links-information-database/technologies/linksdb/technologies/radar/
---------
http://en.wikipedia.org/wiki/Ground-penetrating_radar
The "Mineseeker Project" seeks to design a system to determine whether landmines are present in areas using ultra wideband synthetic aperture radar units mounted on blimps.
Info links:
http://en.wikipedia.org/wiki/Synthetic_aperture_radar
http://en.wikipedia.org/wiki/Ultra_wideband
Here's a link to the FDA's CDRH 2010 Strategic Priorities noted in the article. Looks like government gobbledygook...
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHVisionandMission/ucm197647.htm#Strategy1_1
Looks like the Class of ‘57...
Brikk, it appears that Mr. Ray is an alumnus of Mount Union College located in Alliance OH, which is consistent with your patent link showing Springfield OH, and ozz112’s bmpcoe.org link showing the old glcc.org email...
http://www.muc.edu/alumni_email/alumni_email?do=show_year&year=1957
"James (J.D.) Ray jrglcc@glcc.org" (old email address)
There's some additional info to indicate Mr. Ray, at some point, was located in Blythewood, South Carolina.
---------
South Carolina:
http://www.city-data.com/elec2/elec-BLYTHEWOOD-SC.html
JAMES RAY (GLCC INC) ROGER FOUNTAIN (GLCC)
http://www.city-data.com/elec2/02/elec-WEST-COLUMBIA-SC-02.html
JAMES D. RAY
Wisconsin:
http://www.city-data.com/elec2/94/elec-RACINE-WI-94.html
JAMES D RAY (GREATLAKES COMPOSITES CONSORTIUM) ROGER FOUNTAIN (GREATLAKES COMPOSITES CONSORTIUM)
---------
http://www.linkedin.com/pub/roger-fountain/1/74/4a5
Mr. Fountain is a Past President of Great Lakes Composites Consortium. One will need to sign on to linkedin, in order to view the full profile.
(jmo)
Blog article on medical devices and software issues...
SterlingTech offers software development & validation services for medical devices. I don't remember if the software company that Imaging3 uses has ever been mentioned on this board?
http://www.klocwork.com/blog/?p=609
Developing Software for Medical Devices – Interview with SterlingTech
I had a chance to speak with Bruce Swope, the VP of Engineering at SterlingTech, an ISO13485 Registered full-service medical device software organization offering software development and validation services. SterlingTech has developed software for an array of medical products including implantable devices as well as external support and monitoring equipment. Their team has worked on Class I, II, and III devices that resulted in successful FDA 510(k)s, PMAs, and CE submissions.
Bruce has extensive experience in medical device software development and he is an expert in leading Class III medical software products to commercial release. His depth of experience also spans the development of enterprise solutions, security applications, internal applications, and process control systems. He has been an early adopter of quality practices including ISO 9000 processes, Common Criteria Certification and Capability Maturity Model implementation.
I wanted to talk to him more about the challenges developing software in an FDA-regulated context and what all this means to medical device software development teams.
[Brendan] Given your experience working with a variety of medical device companies, what do you see as the biggest business challenge they face?
[Bruce] The biggest challenge is developing a medical product in a cost effective manner that meets FDA and international regulatory regulations. Most companies have very limited resources available and have boards or investors that are not used to the rigors of regulated development. This often leads to a gap between investor expectations and the reality of getting the product ready for market.
[Brendan] What about technology challenges?
[Bruce] The hardware platforms that the systems are developed for are very expensive in time and money to update once fielded. Often, the hardware is impossible to update without dramatic impact to the patient such as surgery. This creates a need for software developers to find creative ways to extend the life of the hardware by introducing new functionality without updating the hardware. This can often cause the software to become much more complex than planned.
Further, device manufacturers must balance the expectations of customers against the rigor and security required with making a medical product. Consumers are very accustomed to seeing feature rich devices reach the palm of their hand and wonder why their heart pump can’t double as a PDA or MP3 player or why they can’t plug their device into the internet to download new alarm tones.
[Brendan] What’s the most common problem your firm is hired to solve?
[Bruce] Many of our customers are looking for an organization that has experience in working with a given technology to create a product that will be approved by the FDA and international regulatory authorities. They are looking for someone that has the experience to deliver a quality product and a complete design history file without wasted effort or significant delays.
[Brendan] In your experience, do most medical device companies have a clear understanding of the regulatory environment or is there still confusion in the market?
[Bruce] Many of our customers are early stage companies that are looking for us to provide the knowledge of the regulatory environment. Other clients may have an understanding of some aspects of the regulatory environment such as mechanical or electrical but need assistance with the software aspects.
Unless companies invest in dedicated regulatory resources early on and get the FDA or notified body involved sooner rather than later, there will always be confusion and opportunity to misdirect effort.
[Brendan] Any common misconceptions related to compliance issues you can share?
[Bruce] Companies have come to us with a misunderstanding of the impact “level of the concern” will have on the development process for their proposed device. Companies will often put in place a Quality System that is overly burdensome on the software development process.
The result of these mistakes is often that either too much or too little is done to develop the software. Either outcome is damaging. In the case where too much is done, extra cost is incurred and the project completion and entry to the market is delayed. In the case where too little is done, a rejected submission could result leading to further cost and delays.
[Brendan] What’s the #1 recommendation you give to clients as it relates to the intersection of compliance issues and software development?
[Bruce] Make sure that your company has a good solid Quality System as it applies to software development. Do not put a Quality System into place that you can not follow. This is the cause of most audit problems. Use automated tools in your process to allow your developers to focus on the creative parts of the software development. Keep things as simple as possible. Drive out risk early.
[Brendan] Where can people go to get more information? Any good online resources out there?
[Bruce] For an executive overview for determining whether a new device is a medical device or for ideas on how to use a static code analysis tool in medical device development, we have a library of whitepapers people can download.
[Brendan] Thanks!
January 5th, 2010 at 11:58 am
---------
http://www.sterlingtechsoftware.com/html/
This company is attending a Trade Show:
MDM West February 9-11 2010
Booth Number #1256
Anaheim Convention Center
Anaheim, California
gftb,
An interesting video interview of Saxon Ruddick (Managing Director - Designer and Inventor) of Tigerfish Aviation. He said, "floatation around Chicago is ideal for our long term plan of introducing seaplanes back into regional transport..." Mr. Ruddick also mentions they'll be looking to bring technology into the composite floats area...
http://my.wrex.com/_Saxon-Ruddick-Tigerfish-announcement-Paris-Air-Sow/video/690241/29419.html
---------
Here's an older article that includes comments by Mr. Ruddick regarding seaplanes in the New York area...
http://www.nysun.com/new-york/new-plan-on-air-traffic-here-envisages-rivers-as/52668/
World Intellectual Property Organization (WIPO)...
(See documents tab for Tigerfish Aviation)
http://www.wipo.int/pctdb/en/wo.jsp?wo=2002016198
Canadian Intellectual Property Office (CIPO)...
http://brevets-patents.ic.gc.ca/opic-cipo/cpd/eng/patent/2420106/summary.html
http://www.medcitynews.com/index.php/2010/01/new-minnesota-med-device-group-seeks-to-save-510k-program/
New Minnesota med device group seeks to save 510(k) program
January 13, 2010 by Thomas Lee
MINNEAPOLIS, Minnesota– For months, the medical device community has been fretting over what they see as the Food and Drug Administration’s increasingly heavy handed way of approving new technologies.
Now a newly formed grassroots group wants to fight back. The Minnesota Medical Device Alliance Steering Committee, made of some of the state’s most prominent investors, attorneys, and executives, is hosting a meeting in February to discuss ways to push back against critics of the 510(k) program.
They have a lot of work to do. The 510(k) program allows the FDA to approve devices that are similar to other technologies on the market. Yet under pressure from the Democratic-controlled Congress and Obama Administration, the FDA has made it increasingly difficult to win 510(k) clearance by imposing costly and unnecessarily strict testing requirements on start-ups who can least afford them, said Mark DuVal, a local attorney and FDA specialist seeking to mobilize Minnesota’s med tech industry.
The 510(k) scrutiny has received the same amount of attention than, say, the proposed $20 billion medical device tax to fund health care reform. But the issue matters far more to the med tech industry because toughening or even eliminating the 510(k), as some people fear, will stifle innovation by blocking companies from delivering promising technologies to market, DuVal said.
Not sure how the new alliance will differ from industry organizations like LifeScience Alley and Advanced Medical Technology Association. But judging from the group’s roster, it’s clear that some of Minnesota’s most prominent brains feel more needs to be done.
A Call-to-Action: Make Your Voice Heard on the 510(k) Program
Wednesday, February 17, 2010
Brought to you by the Minnesota Medical Device Alliance Steering Committee
* Jim Bullock – Atritech
* Mark DuVal – DuVal & Associates
* Kris Johnson – Affinity Capital Management
* Tom Letscher – Oppenheimer Wolff & Donnelly LLP
* Rich Lunsford – Anulex Technologies
* Mark McKoskey – MedTech Resource Alliance
* Pete McNerney – Thomas, McNerney & Partners
* Dave Stassen – Split Rock Partners
* Eric Timko – NeuroVasx, Inc.
As we all know, the 510(k) program has been under siege for some time and is facing greater challenges than ever in the wake of proposed administrative and legislative changes. Because the end product will have an enormous impact on Minnesota’s medical device and investment communities, we must act now and make our voices heard at FDA and Congress.
The FDA wants to be transparent with a new 3 phased "Transparency Initiative" (FDA Kool Aid anyone?)...
http://www.dailyfinance.com/story/fda-made-easy-new-site-shows-how-agency-works/19315382/
FDA Made Easy: New Site Shows How Agency Works
MELLY ALAZRAKI
Posted 3:54 PM 01/13/10 Healthcare
Ever wonder whether the U.S. Food and Drug Administration approves cosmetics? Or how a new prescription drug is approved? How often the FDA inspects food manufacturing facilities? Or how the FDA assesses the safety of vaccines? Now, you can find answers to all these questions and more at a new web resource launched by the FDA.
On Monday, the FDA unveiled the first phase of its Transparency Initiative, which aims to help consumers gain better understanding of the regulatory agency. It's designed to explain the agency's operations, how it makes decisions, and the drug approval process, among other things.
Through the new FDA Basics page on its site, the public can get an overview of what the agency does, said the chairman of the FDA's Transparency Task Force, Dr. Joshua Sharfstein. The site's resources include questions and answers, short videos, and conversations with agency personnel. In the future, the agency intends to add online sessions in which senior officials will answer questions on various topics.
Making the Information That Was There More User-Friendly
The Transparency Initiative was launched in response to the Obama administration's commitment to "an unprecedented level of openness in government," the statement noted. But beyond Obama's goal to increase transparency, the move is a response to long-standing critiques regarding the FDA's operating style. Just recently, the Government Accountability Office noted concerns about the FDA's oversight of post-market drug safety. It's not surprising, then, that one of the first moves by FDA Commissioner Dr. Margaret A. Hamburg -- appointed in May of last year -- was to increase transparency at the agency.
As Dr. Sharfstein noted earlier, "The FDA website currently contains significant amounts of information, but the content may be best understood by those who are familiar with the agency." To begin to address that problem, in recent months, the task force solicited public input on improving agency transparency. The result was the creation of the FDA Basics page. "This initiative will make information about the FDA more user-friendly and accessible to the public," said Dr. Hamburg. Whether that's accurate, though, remains to be seen.
One of the first questions on the FDA Basics site is: "Can I tell if FDA has approved a product by looking at the label?" The answer starts with a simple 'No,' accompanied by phone numbers, email addresses and a url for where the public can find the information. But, inevitably, things get complicated. For example, vaccines, medical devices and animal products are separate categories, and the information about them is on other pages on the site. The information is all there, but it would be difficult to simplify.
Two more phases in the transparency initiative are upcoming. In phase two, the task force intends to make recommendations regarding how to make information about agency activities more transparent while protecting confidential information. These recommendations will be released at the end of February. Only in the final phase, the task force intends to make recommendations regarding the FDA's regulated industries, including how to provide information on the status of an application under review by the agency. This phase is expected to be completed two months after the second phase.
By the way, if you're curious about the answers to the questions posed at the beginning of this article: No, the FDA does not approve cosmetics, although it does approve color additives used in cosmetics; its process for new drug approvals consists of several stages; its frequency for inspecting food manufacturing facilities is based on several factors; and vaccines undergo extensive testing to determine their safety and effectiveness.
---------
Link to FDA news release dated 01/12/2010:
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm197222.htm
The FDA's Center for Devices and Radiological Health regulates radiation-emitting products...
http://www.fda.gov/Radiation-EmittingProducts/default.htm
From what I've read... even non-medical devices that emit forms of radiation "must comply with radiation safety performance standards" set by the FDA's CDRH.
http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/default.htm
"Q4) What gives FDA the authority to regulate manufacturers of radiation-emitting electronic products?
A) The FDA’s statutory authority to regulate these products is granted by the United States Federal, Food, Drug and Cosmetic Act, Chapter V, Subchapter C, Electronic Product Radiation Control. Federal Food, Drug, and Cosmetic Act, Chapter 5, Subchapter C - Electronic Product Radiation Control
Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 through 1050 (21 CFR 1000 – 1050) contains radiation safety regulations for manufacturers of radiation-emitting electronic products. Manufacturers are responsible for producing products that do not emit hazardous and unnecessary radiation. All manufacturers must comply with the applicable requirements in Title 21 CFR 1000, 1002, 1003, 1004 and 1005. If a mandatory radiation safety performance standard applies to a manufacturer’s product, then the manufacturer must also comply with Title 21 CFR 1010 and the product must comply with the requirements of the standard. Mandatory radiation safety performance standards are found in 21 CFR 1020 – 1050."
(jmo)
Thanks mr_sano!!
Last week, there was discussion concerning unscreened cargo at airports, specifically American Airlines that has approximately 10% of their cargo screened.
Please link back to when the discussion began with a post made by Nina4900. I don't remember any comments regarding human screening...
mr sano,
You previously acknowledged my original request of 01/19/2010...
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=45029010
I agree. Imaging3 has been on the FDA waiting list for 2 1/2 years. Any new company will probably have to go through the same FDA hoops as the Dominion, whether it's for medical or airport security applications...
It also seems that after the Dominion's FDA Clearance as a medical device, there should probably be little delay in extending their application to Homeland Security.
goldcoastoh,
Please review this recent article & the technical information found for this "new X-ray device." There is no Realtime 3-D claim for this machine with "super imaging power."
Nesch,LLC is a private company in Merrillville Indiana looking for applications of their X-ray device to be used in airport security. Eventually, it appears they will be seeking FDA Clearance for the DEXI-LRM1 in the medical industry.
Also, please check the links below and let us know your opinion of their X-ray device, patent portfolio and the radiation dose calculations for their DEXI-LRM1...
http://www.post-trib.com/news/1970235,scanner-machine-0101.article
New X-ray device has super imaging power
DEXI can detect guns, explosive powders
January 3, 2010
BY TERESA AUCH SCHULTZ, (219) 648-3120
The workers at a Merrillville company have spent the past six months developing their own form of airport security -- a machine they say is superior to the metal detectors and body scanners making the news.
Guns, explosive powders, plastic weapons -- the machine can show them all, no matter where they're at.
Even if they're inside a human body.
If everything goes according to their plan, the Purdue Technology Center incubator-based Nesch LLC will see its product in airports worldwide helping to stop terrorists from using airplanes as their personal weapons.
The device called Diffraction-Enhanced X-ray Imaging, or DEXI, is basically an X-ray machine on steroids -- but with far fewer X-rays. A normal X-ray machine will use three sources -- light absorption, refraction and scattering -- to produce one image. Because the light refractions and light scatterings don't mix well, the result is a blurry image, one that picks up on bones but not soft tissue.
Ivan Nesch, CEO of Nesch LLC, says that DEXI creates a separate image from each of the sources that makes for not just clearer pictures but allows people to see softer material -- including powders like the one a Nigerian man supposedly brought with him on a Christmas Day flight to blow up the plane.
"(With conventional X-ray machines,) you could not even think about this," Nesch said.
Pictures provided by Nesch show various objects taken with a conventional X-ray and the DEXI system. In conventional X-rays, plastic bags filled with powder are obscured but are clearly seen in images taken by DEXI. Another DEXI image shows a plastic knife hidden in another object.
No comment from U.S. Rep. Peter Visclosky, who has thrown his weight behind the incubator, was available as of Thursday.
Carol Muehleman, an anatomist and professor at Rush University's Department of Biochemistry and an adviser for Nesch LLC, says the images are a significant improvement of conventional X-rays' capability.
"For the first time, soft tissues can be seen with X-rays," she said. "Not just bone, but soft tissues, ligaments, tendons, skin even."
DEXI's original use was for medical testing. A small machine has been made to take images of lab animals such as rats and fish. Nesch said he and his co-workers started thinking about other applications for the product, though, and began focusing on security uses about six months ago. Since then, they've come to realize how it could benefit air travel safety, he said.
"We're the only technology that can pick up drugs and explosives hidden inside the body," Nesch said.
DEXI also doesn't get confused just because an object is behind, say, a bag of water, which Nesch claims happens to other body scanners. Powders and water absorb X-rays at about the same rate, meaning the picture created is one big blur. DEXI can distinguish the two, Nesch said.
Another benefit, Nesch said, is that the machine uses less X-ray radiation than a normal X-ray machine does -- about 50 times less. Even for a person who flies frequently, the machine gives out a fraction of the X-rays that a person picks up just by flying, Nesch said.
As for privacy concerns, Nesch said his product is superior because it doesn't reveal body shapes. His company is also working on creating an elemental analysis program, meaning a computer can do any initial scans to see whether something is showing up that officials need to look at more closely, Nesch said.
The hope is that the images will also be simple enough so workers will not have to be specially trained to view them, he said.
Using the machine in airports also could help the company get approval from the Federal Drug Administration to use it on humans for medical purposes. The company can collect data as the device is put to use in airports, Muehleman said. The data could then be submitted to the FDA. The machine could eventually be used in mammograms and other clinical testing.
Although DEXI isn't cheap -- the main component will likely cost around $160,000 -- it will be in the same price range of other full-body scanners, Nesch said. The company expects to be ready to start taking orders by March and producing machines by the second half of 2010. So far, Israel, India, Saudi Arabia and other countries have shown an interest in purchasing the machines. Nesch LLC also has a contract with a company to sell them in Latin America, Nesch said.
http://www.neschllc.com/index.html
http://www.neschllc.com/products/documents/dose-calculations_DPF.pdf
Found someone interesting that works with Vincent & Rees...
http://www.linkedin.com/pub/lisa-demmons/9/4b4/31a
Current•Of Counsel at Vincent & Rees
Greater Salt Lake City Area
Past•Of Counsel at Fabian & Clendenin
•Attorney at Sole Practitioner
•Associate Attorney at Parsons Behle & Latimer
see less...
Education•Thunderbird School of Global Management
•Willamette University College of Law
•University of Puget Sound
Connections 48 connections IndustryLaw Practice Websites•Fabian & Clendenin
•Vincent & Rees
---------------------------------------------------------------------
Lisa Demmons’s Summary
Lisa Demmons’s Specialties:
Mergers & Acquisitions; Venture Capital Financing; Start-up Companies; Techlaw
---------------------------------------------------------------------
Lisa Demmons’s Experience
Of Counsel
Vincent & Rees
(Law Practice industry)
April 2007 — Present (2 years 9 months)
Of Counsel
Fabian & Clendenin
(Privately Held; Law Practice industry)
2005 — January 2009 (4 years )
Attorney
Sole Practitioner
(Law Practice industry)
2002 — 2005 (3 years )
Associate Attorney
Parsons Behle & Latimer
(Law Practice industry)
2000 — 2002 (2 years )
---------------------------------------------------------------------
Lisa Demmons’s Education
Thunderbird School of Global Management
MBA , 1998 — 1999
Activities and Societies:Commercial Chinese Language
Willamette University College of Law
JD , Law , 1995 — 1998
Activities and Societies:President, International Law Society
Managing Articles Editor, Willamette Bulletin of International Law and Policy
China Law Summer Program, Shanghai
University of Puget Sound
BA , Comparative Politics , 1991 — 1993
Activities and Societies:Varsity Ski Team
Scholar Athlete
---------------------------------------------------------------------
Additional Information
Lisa Demmons’s Websites:
Fabian & Clendenin
Vincent & Rees
Lisa Demmons’s Interests:
Mergers and acquisitions, venture capital financing, start-up businesses, skiing, hiking, fly-fishing
Lisa Demmons’s Groups:
Thunderbird Alumni
Willamette University College of Law Alumni
---------------------------------------------------------------------
Lisa Demmons’s Contact Settings
Interested In:
•consulting offers
•new ventures
•expertise requests
•reference requests
•getting back in touch