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Friday's 72% selling and 28% buying convinces me that today is most likely another additional information request from the FDA. Unfortunately, I gave away roughly 60% (465k) of my holding in Imaging3 last Friday based on the situation we are in now. Depending on what Dean has to say today, we will be able to tell for certain if our situation with the FDA is fatal after all. Good luck to everybody!
Mary Sawa
Here's an interesting breakdown of the 510K process...
There are three types of FDA 510(k) Premarket Notifications. The most common is the Traditional 510(k) which is required for most new products. Many people confuse the 1-2 page “Summary” published on the FDA website with the complete application that must be submitted to the FDA. This summary is exactly what it means - a summary. A final 510(k) application when submitted is often 50-100 pages in length, not including any applicable testing reports for your product. The FDA does not publish a template that you must follow for a 510k submission, but it must address the 21 sections shown below.
1.Medical Device User Fee Cover Sheet
2.CDRH Premarket Review Submission Cover Sheet
3.510 (k) Cover Letter
4.Indications for Use Statement
5.510 (k) Summary or Statement
6.Truthful and Accuracy Statement
7.Class III Summary and Certification
8.Financial Certification or Disclosure Statement
9.Declarations of Conformity and Summary Reports
10.Executive Summary
11.Device Description
12.Substantial Equivalence Discussion
13.Proposed Labeling
14.Sterilization and Shelf Life
15.Biocompatibility
16.Software, if applicable
17.Electromagnetic Compatibility and Electrical Safety, if applicable
18.Performance Testing – Bench, if applicable
19.Performance Testing – Animal, if applicable
20.Performance Testing – Clinical, if applicable
21.Other
Here is some additional information on those sections as provided by the FDA.
1. Medical Device User Fee Cover Sheet
The Medical Device User Fee Cover Sheet and receipt of the user fee payment, allow FDA to begin processing your submission; therefore, you should provide a Medical Device User Fee Cover Sheet with your 510(k) submission, unless it is a third-party review submission. Third-party review submissions are exempt from user fees. Although the following 510(k) submissions are also exempt from user fees, we recommend you include a Medical Device User Fee Cover Sheet, and use it to indicate the type of exemption that applies in the case of 510(k) submissions: intended solely for pediatric use (a change in the intended use from pediatric use to adult use requires the submission of a new 510(k) in accordance with 21 CFR 807.81(a)(3); and an associated fee) submitted by a state or Federal government entity (exempt from the FDA user fee unless the device is to be distributed commercially).
2. CDRH Premarket Review Submission Cover Sheet
The CDRH Premarket Review Submission Cover Sheet is a voluntary form used to help provide basic administrative information for all types of premarket notification submissions.
3. 510(k) Cover Letter
We recommend that you include a 510(k) Cover Letter with your submission. See Appendix A for more information on the proposed and suggested content of the 510(k) Cover Letter. Appendix A describes key information that may be useful to FDA in the initial processing and review of the 510(k) submission. In contrast with the CDRH Premarket Review Submission Cover Sheet from Section 2, the 510(k) Cover Letter described in Section 3 is intended to be more descriptive of a 510(k) submission.
4. Indications for Use Statement
We recommend that you use this section to provide the indications for use statement, which is a document where you identify and describe the specific indications for use statement for the device(s) included in the 510(k) submission. Your indications for use statement should be exactly the same as the indications for use listed throughout the rest of your 510(k) submission, including the indications for use in the device labeling. We believe that in order for FDA to adequately review your submission you should identify whether the device is intended for prescription use and/or over-the-counter use.
5. 510(k) Summary or 510(k) Statement
In accordance with 21 CFR 807.87(h), each 510(k) submission must include either a 510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93). We recommend that you use Section 5 to provide the 510(k) Summary or 510(k) Statement. A 510(k) Summary provides a brief summary of the device included in the 510(k) and the supporting information. A 510(k) Statement is a certification that the 510(k) holder will provide a copy of the 510(k) submission, with certain exclusions, to any person within 30 days of a written request.
6. Truthful and Accuracy Statement
In accordance with 21 CFR 807.87(k), all 510(k)s must include a statement certifying that all information submitted in the 510(k) is truthful and accurate and that no material fact has been omitted. The submitter should sign and date the statement.
7. Class III Summary and Certification
If your 510(k) is for a device type classified into class III for which we have not called for PMAs, it must contain a Class III Summary and Certification in accordance with 21 CFR 807.87(j) and 807.94. The Class III Summary and Certification provide a review of the risks and adverse events known and associated with the general category of devices into which the proposed device falls.
8. Financial Certification or Disclosure Statement
In accordance with 21 CFR 807.87(i), if you submit information from clinical studies, you must submit a financial certification and/or a disclosure statement for each clinical investigator who participated in your study.
9. Declarations of Conformity and Summary Reports
If your 510(k) is an Abbreviated 510(k) submission, we recommend that you use this section to provide the information regarding any declarations of conformity to a standard or a summary report recommended in any relevant device-specific guidance. As mentioned in the definitions section of this guidance, an Abbreviated 510(k) is a type of 510(k) in which you choose to declare conformance to a recognized standard for any part of the device design or testing or you choose to prepare a summary report to a guidance. If you choose to rely on a recognized standard or a guidance for any part of the device design or testing, you may include either a: declaration of conformity to the standard or summary report recommended in any relevant device-specific guidance; or a statement that testing will be conducted and meet specified acceptance criteria before the device is marketed. Because a declaration of conformity is based on results from testing, we believe you cannot properly submit a declaration of conformity until you have completed the testing the standard describes.
10. Executive Summary
In this section of your 510(k), we recommend that you provide an executive summary of the 510(k), which should include a: concise description of the device, including the indications for use and technology; device comparison table; and concise summary for any performance testing in the submission. The description, although concise, should be sufficient to provide an overall understanding of the device. The device comparison table should outline the differences and similarities between your device and the predicate. We recommend that you also provide a discussion of how this comparison supports substantial equivalence. The summary for each performance testing section (i.e., sections 18, 19, and 20) should be sufficient to provide a broad understanding of the type of testing performed, the methods used, and your conclusion from the results.
11. Device Description
We recommend that you describe the performance specifications and include a brief description of the device design requirements in this section. We also recommend that you identify all models, as well as all accessories or components, included in the submission. If diagrams, dimensions, tolerances, and/or schematics are useful to fully describe and characterize the device, we recommend that you include them for each device, accessory or component included in the 510(k) submission. We also recommend that you provide a list of all patient contacting components and their respective materials.
12. Substantial Equivalence Discussion
In the substantial equivalence section, we recommend that you identify the predicate and identify its trade name, model number, 510(k) submitter/holder, and 510(k) number, if available. You may choose to identify, compare, and test against more than one predicate, if, for example, your device has two features or indications not previously combined in a single predicate. We recommend that you provide a detailed comparison between your device and the predicate sufficient to demonstrate the substantial equivalence of the devices, as applicable, in terms of: indications for use; technology; and performance specifications, including any testing.
13. Proposed Labeling
The 510(k) must include proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). If the device is an in vitro diagnostic device, the labeling should additionally satisfy the requirements of 21 CFR 809.10. Generally, the term “labeling” includes the device label, instructions for use, and any patient labeling.
14. Sterilization and Shelf Life
For devices sold as sterile, we recommend that you follow the guidance, Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA. For devices that are reprocessed single use devices, please refer to Guidance for Industry and FDA Staff – Medical Device User Fee and Modernization Act of 2002 Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices. For a submission that identifies a shelf life for the device, your shelf life should be supported by appropriate bench tests and/or sterilization (packaging) validation.
15. Biocompatibility
If your device contains components that come into direct or indirect contact with patients, you should evaluate the biocompatibility of the patient-contacting materials. You should select biocompatibility tests for the duration and type of contact appropriate to your device design and submit the pass/fail criteria or in some cases, a summary of the results. If identical materials are used in a predicate with the same type and duration of patient contact, you may identify the predicate in lieu of performing biocompatibility testing and state that your device is comprised of identical materials and that are processed by identical manufacturing methods. This is most appropriate if you are the manufacturer of the predicate and you have complete documentation with respect to the manufacturing methods and materials employed.
16. Software
This section should include the appropriate software documentation as described in the guidance titled Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. As discussed in the guidance, we recommend that you identify the “level of concern,” (minor, moderate, or major) associated with your device and provide documentation consistent with that level.
17. Electromagnetic Compatibility and Electrical Safety
If your device design includes an electronic component , we recommend that you evaluate its electromagnetic compatibility (EMC). EMC encompasses both emissions (interference with electronic products) and immunity (interference with device performance created by emissions from other electronic products). We recommend you test your device according to IEC 60601-1- 2 Medical Electrical Equipment — Part 1: General Requirements for Safety; Electromagnetic Compatibility — Requirements and Tests (Second Edition, 2001) or equivalent method to demonstrate the EMC characteristics of your device. If your device design results in patient contact with any electrically powered component, FDA recommends that you follow IEC 60601 1 (1988): Medical electrical equipment – Part 1: General requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995) or an equivalent method.
18. Performance Testing – Bench
If you submit bench test results to support substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B. You should describe the bench testing and provide the results that support the performance characteristics of your device. Generally, all submissions should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. We also recommend that your conclusions describe any comparison testing with the predicate in terms of substantial equivalence.
19. Performance Testing – Animal
If you submit animal test results to support substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B. If you conducted animal testing, we recommend that you describe the tests and provide the results that support the performance characteristics of your device. Generally, all submissions that describe animal testing should include the information below; however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. The branch or team responsible for the review of your device is also available to assist you with any questions about animal testing. We also recommend that your conclusions describe any comparison testing with the predicate device in terms of substantial equivalence.
20. Performance Testing – Clinical
If you submit results from clinical studies to demonstrate substantial equivalence, we recommend you include the following information in this section. If the device is an in vitro diagnostic device, refer to Appendix B. FDA will always consider alternatives to clinical studies when the proposed alternatives are supported by an adequate scientific rationale. Our recommendations for clinical testing typically depend on many factors including device type, intended use, design, safety profile, and clinical experience. Generally, all submissions that describe clinical studies should include the information (required by FDA); however, if a relevant device-specific guidance is available, you should follow the recommendations in that guidance document. The branch or team responsible for the review of your device is also available to assist you with any questions about studies. If your submission describes clinical studies, we recommend that you provide the clinical protocol. We also recommend that your conclusions discuss any comparison testing with the predicate device in terms of substantial equivalence.
If your study is considered significant risk, the study must be conducted under the IDE regulation, 21 CFR Part 812 if it is conducted in the United States. If, however, your study is considered non-significant risk, the study is subject to the abbreviated requirements of 21 CFR Part 812.2(b) only. In all cases, sponsors of clinical trials must comply with the regulations governing institutional review boards (21 CFR Part 56) and informed consent (21 CFR Part 50).
From what it sounds like, we are at the end of the process and still arond the 150 day window!
IS_guru, this is breath-taking DD! Excellent work you are a great contribution to this board and investors!
I'd be a fair candidate...
Wall Street Report Interview with Dean Janes
Imaging3, Inc. (Imaging3) is a medical device manufacturer, distributor and third-party service provider. The Company has developed a technology, known as Dominion, which utilizes photo-fluoroscopy to produce three dimensional (3D) medical diagnostic images in real time. Imaging3 is also a remanufacturer of C-arms. The Company offers new, demonstration, remanufactured, refurbished and pre-owned systems in all price ranges from every manufacturer, including OEC, General Electric (GE), ISI, Philips, Siemens, FluoroScan, XiScan and Ziehm. The Company supplies full-size, compact and mini C-arms.
TRANSCRIPT:
WSR: Good day from Wall Street. This is Juan Costello, Senior Analyst with the Wall Street Reporter. Joining us today is Dean Janes, CEO of Imaging3 Incorporated, also Chairman of the Board. The company, Imaging3, trades on the OTC Bulletin Board, the ticker symbol is IMGG. The company is a medical device manufacturer, distributor as well as a third-party service provider. Thanks for joining us today Dean.
Dean Janes: Thanks for having me.
WSR: Start off by giving us the highlights of the recently filed 10-Q.
Dean Janes: The 10-Q that we just recently filed represents our first quarter financials. As you know, we are an emerging technologies company. We fortunately have an existing business, which is C-Arms and C-Arm tables where we re-manufacture them. I believe we posted a loss, but the big picture in this company is our proprietary technology, the Dominion Vi Scanner, which is pending FDA approval, which we hope to have approved soon and head into the marketplace. So, for investors that are looking at this potential company, they need to look at the long-term picture of this — the potential of the Dominion Vi Scanner into the marketplace.
WSR: Bring us up to speed on Dominion, give us some of the uses in applications in the market as well as talk a little bit about the 3-D technology?
Dean Janes: We’re talking about a truly revolutionary product. We have two patents on this device. When we decided to go down this road, we did an extensive patent searching and found nothing in this space whatsoever, which was reaffirmed when our patents allowed on its first office action in all of its claims and subsequently, same happened with our continuation patent. There was a lot of office action in all of its claims. What this device is? It’s a circular gantry device, it scans around the body in 360 degrees, every two-tenths to eight-tenths of a second. It takes images, puts those into a 3-D construct and then again updates those every two-tenths to eight-tenths of a second thus giving you real-time 3-D imaging. Our device is portable, it plugs into regular wall power and fits through regular room doors. So, there is no exotic power requirements or construction requirements to use this device. It can be used throughout the facility in BOR and ER and interventional radiology for spinal surgery, vascular surgery, for diagnosis procedures in minimally-invasive surgical techniques. The price point of our product is very attractive as well, 550,000, which is one-third the cost of a new CT scanner. Our higher-end product also provides CT imagery as well. So, it’s a really exciting technology and a truly innovative and breakthrough technology that is pending FDA approval, which we hope to have relatively soon. We’ve taken the time to process to build our manufacturing requirements, potential customers as well as financing requirements.
WSR: Talk about some of the market trends as far as medical imaging? How well positioned the company is to capitalize on some of the emerging trends?
Dean Janes: The current trend today is the economy, it’s economy driven, but that actually works to our advantage where people are looking for bargains. They’re looking for high-value added products that don’t perform just one function and aren’t fixed into a single room. As I’ve mentioned, our product can be used for several different types of procedures both diagnostic and for interventional use. Also our product is mobile, it can be used throughout the facility. So, it’s not fixed to a single location to only perform urology. It can do urology plus interventional radiology plus surgery plus trauma. This multi-functionality adds to the attractiveness of a hospital wanting to purchase this. It can also be used in smaller surgery centers and even in a doctor’s office.
WSR: What differentiates Imaging3 from other players in your sectors, your patented technology, is it the service or both?
Dean Janes: It is. It’s a truly differentiated product. It’s the only product that performs three-dimensional imaging in real time. Every competitor out there has 3-D, but it’s all post-processing, which is usually hours or days old information. Ours is doing this in real time. We’re in three dimensions and when doctors are trying to perform procedures using a 2-D fourier system, they can only see depth or direction. They can’t see both. They can’t be able to see and guide anything invasive into the body or do diagnostic procedures without having to move you or the imaging equipment around you, whereas our device instantaneously generates these images and instantaneously updates those images in less than a second.
WSR: Talk a little about the company’s growth Dean in terms of growth, you continue to grow organically or look for M&A activities?
Dean Janes: There are some ongoing talks in M&A, but mainly we will grow organically. We will grow through the leads of the potential purchasers that we’ve been building from our trade show appearances and through our installed base. We have over 700 active customers that we’ve installed over the years since 1993. I actually founded this company to do re-manufacturing work and have a very good attractive customer base, which we can build off of from there, referrals from there, as well as actively pursuing customers. Like our trade show, we were at just last year, and we will be again at this year’s Radiological Society of North America in Chicago and attract 70,000 physicians from all over the world and we’ve been there for a few years and have attracted great interest in this product.
WSR: Walk us through your background and experience Dean as well as that of some of the key management team at Imaging3.
Dean Janes: I’m the founder of this company. I founded this company out of the back of my car in 1993 to form service and re-manufacture of X-ray equipment. I am a biomedical engineer and I work for most of the major manufacturers as either an engineer or a support technician to assist with high-end products like CT, MR and cath labs. I have my President and COO who is a UCLA grad who helps us with international distribution issues as well as partnerships for manufacturing. His name is Chris Sohn. Xavier Aguilera has over 20 plus years of experience in banking and in healthcare. He is on the boards of few banks and also few hospitals. Mike Nessen, my VP of Business Development, has been in business for decades with experience in building sales and management teams. He brings a lot to the table as well. We have a really good group of management that is focused on taking this product to the marketplace and making it a success.
WSR: Talk a little bit about what specific milestones and objectives has the management team set for the company over the next year?
Dean Janes: As far as sales?
WSR: As far as overall company objectives.
Dean Janes: Basically, we have our major milestone with FDA approval, which we hope to have relatively soon. The next milestone will be distributing the product to what we call luminary sites. We will have a dozen, half dozen sites that will be high profile sites with esteemed facilities like, I can’t really name names, but major facilities all over the United States where we can draw from their strengths as far as having the exposure into the medical community. From those sites, we’ll use those as demonstration sites to have other facilities, potential buyers go and visit, call, do site visits to see this technology in action. That’s our first year milestone of what we expect to do in sales. Now, we have many, many more sales lined up from there. We hope to have in our first year, roughly between a dozen to three dozen systems installed throughout the country. We could go much further beyond that, but I think initially, we’ll have a slower entry pace, but we’ll definitely start going into the hundreds of systems beyond that.
WSR: In terms of investors, do you believe that investors understand the general direction of the company?
Dean Janes: I believe so. We’ve had a very strong following since we became public, I think about three years ago and very strong following with investors. Many of our investors, friends, family and others that came along through our private offering have been following us before we were a public company, before we even had a patent. Obviously, they are all anxiously anticipating our FDA approval and getting ourselves towards a development company to a production company.
WSR: Once again, joining us today is Dean Janes, Founder, CEO and Chair of Imaging3 Incorporated and the company trades on the OTC Bulletin Board, ticker symbol is IMGG, once again IMGG on the OTC Bulletin Board currently trading at $0.05 a share. Before we conclude Dean, what are some of the key reasons why Imaging3 represents a good long-term investment opportunity to potential investors?
Dean Janes: That’s a really good question and I think this is a type of company every investor is looking for. A company on the verge of a major milestone and having a truly revolutionary product that’s patented and not just with a single patent but multiple patents and multiple claims. So, I think that’s really the attractive aspect. Our share price is still right now at $0.05 a share, it’s a bargain. I think this is a very attractive investment for people that are looking for a breakout company.
WSR: We certainly do look forward to continue to track the company’s growth and I’d like to thank you for taking the time to update our investors today.
Dean Janes: I appreciate you for having me.
5/14/2009
And for those that didn't believe me when I listed all of those facts just listen to this conference call http://www.imaging3.com/State_of_Company7-6-09.mp3.
The reason why many machines can be built and assembled fairly rapidly is because the blueprint is fairly simple. The parts that make up the DViS are off the shelf and are available in high volumes. The manufactering company and Imaging3 headquarters will basically be doing an assembly job putting the Dominion together. However, a certified Imaging3 employee or contractor will be in charge of installing the software and troubleshooting the device for any potential errors or issues. Imaging3 will not serve as a repairing or service company either. They will provide this option to the customer by introducing them to a 3rd party service provider that will be certified by an Imaging3 engineer to work on the Dominion if it has any issues. However, Imaging3 will be directly dealing with any software issues or updates. Customers will also have the option of upgrading firmware or upgrades either free or for a one-time fee based on the company's progress with the FDA and how many 510k claims they can get approved after the initial submission has been cleared. I believe the company will begin production as soon as approval is granted but will most likely be purchased by a larger company because the potential of the DViS is great! This is a great stock to be holding right now especially if you're in at the price I've been in for a while now :). Good luck to you my friend.
IMGG Post-FDA Facts
- Imaging3 has married a deal with a overseas Korean manufacturing company that can produce up to approximately 1000 units per month.
- Imaging3 can produce up to 10 units per month approximately in their own facility.
- Imaging3 CEO Dean Janes consulted with an M & A (Merger & Acquisition) Attorney regarding the company's future plans.
- Imaging3 has several non-disclosure agreements with several companies including Toshiba and General Electric.
- Rumor that Medtronics is interested in buying Imaging3 as a replacement and upgrade of their O-Arm product which was recently recalled by the FDA.
- 150 days closing in on FDA's determination of decision.
- Imaging3 CEO is not going to sit back and wait to be bought out. He is ramping up production status in order to 1.) produce the DViS as a company themselves, and has setup deals with different distributors and venders in the United States and overseas as well and 2.) increase the value of the company by being a company with sales and a great reputation and evidence of demand for their product. Dean does not know if the company will be bought out but is certainly open to the best option for the shareholder.
- Imaging3 has picked up numerous venders and hot leads (demanded buyers) from RSNA trade shows especially. The number stands at 500 instant buyers and afterwards 500+ potential leads. The exact number has not been determined yet.
The information above has been confirmed and are facts.
Mary Sawa :)
Pretty nice but old video of the DViS in action...
I don't deny this but based on poor Dean's luck we may be that 2% unforunately. I just don't want anybody creating a false hype and allow the stock to tank in case we don't satisfy this date and prediction for a response.
FDA 1st quarter performance report for 2010 510K
90% within 90 days 100% within 150 days decision issued...
Yes that's right. But that was only for 2010 510K. The FDA's overall statistics (shown on the FDA's website in the link I provided in my previous post) indicates that 98% of all 510K submissions are decided within 150 days. I certainly hope that we will have approval as soon as possible, but I don't want anybody to create a promise and hype which may not entirely be true.
<<Assyria_Will_Rise - No this is not correct. Nothing is 100% especially not with the FDA. They aren't held accountable to any deadlines on a 510K submission. They have guidelines, but not deadlines. 150 days comes into play and statistically 98% of the submissions receive an answer.
90% of 510(k)s in 90 days
98% of 510(k)s in 150 days
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109319.htm
Absolutely I agree. Only time will tell but I think we're in really good shape. Good luck to you my friend!
Nobody knows maybe Dean did botch the submission, we certainly hope not! However, with all the circumstances surrounding our submission now, in my opinion, we have a great chance.
I don't want to point any fingers, I just want this process to come to a conclusion. You're absolutely right that only time will tell.
The other day I went to my local DMV/MVD for a simple request. They were so slammed and busy with seemingly barely any employees working. It took me about two solid hours to get what I wanted done. But initially I thought it would only take maybe at most 30 minutes. I know this has no direct comparison to the FDA, but it just goes to show that the government (both state and national) are hurting more than ever now. The fact is we're very much in debt and cutting costs has been very crucial lately. I can only assume that the FDA is suffering this problem as well. I bet they are over-loaded with applications and limited on reviewers, equipment, etc... That's just an assumption though.
We'll see what happens here very shortly IMO.
AWR
kimble, my post didn't concern any luminary sites or anything of that sort. I was directly referring to their timing with the FDA in the 510k submission process. It's great reference for us investors because this is reality. It took them about 5 months and this is where we find ourselves at today as well.
Nothing in life is 100%, but BSDM's news today revealed great news for us as well! I saw many similarities comparing the two companies' submissions.
IMO we're in great shape for approval this time around.
Good luck to all.
- AWR
Let's take a close look here...
IMGG'ers we must congratulate our friends over at BSDM on their 510k approval today. However, let's take a close look at the timing duration in the FDA's 510k process.
Here is a copy & paste of their press releases (start from bottom and read your way up)...
******BSD Medical Receives FDA 510(k) Clearance to Market the MicroThermX Microwave Ablation System August 18, 2010******
BSD Medical Sells Hyperthermia System to Oregon Health & Science University August 2, 2010
BSD Medical Submits Grant Applications under the Qualifying Therapeutic Discovery Project Program July 26, 2010
******BSD Medical Provides Information Requested by FDA for the MicroThermX Ablation System 510(k) Submission July 21, 2010******
BSD Medical Announces Presentation at ASCO of Duke University Clinical Study Using Hyperthermia with Chemotherapy to Treat Bladder Cancer July 15, 2010
******BSD Medical Reports Progress in the FDA Review of MicroThermX Ablation System 510(k) Submission July 12, 2010******
BSD Medical Exhibits MicroThermX® Microwave Ablation System at World Conference on Interventional Oncology June 23, 2010
BSD Medical Reports Hyperthermia Use with Particle Therapy Highlighted at German Society of Radiation Oncology Meeting June 17, 2010
BSD Medical Reports Presentation of Cochrane Review on the use of Hyperthermia in Cervical Cancer Treatment at ESHO 2010 Meeting June 8, 2010
BSD Medical Reports Impressive Results from Clinical Study on Pancreatic Cancer Presented at ESHO 2010 Meeting June 2, 2010
BSD Medical Reports Press Release Issued by The Lancet Oncology on Significant Sarcoma Study using BSD-2000 Hyperthermia System May 4, 2010
******BSD Medical Announces Registered Direct Offering of Common Stock and Warrants in Aggregate Amount of $2.5 Million May 3, 2010******
BSD Medical Reports Study Results Published in Lancet Oncology Demonstrate Improved Survival for Sarcoma Cancer Patients Treated with Hyperthermia April 29, 2010
Clinical Study using the BSD-2000 Hyperthermia System Combined with Chemotherapy to Treat Pediatric Tumors Shows Promise April 22, 2010
TV News Coverage Reports on Duke University Hyperthermia Research Using BSD Medical’s Equipment March 25, 2010
******BSD Medical Files FDA 510(k) Submission to Market Phase II MicroThermX Ablation System March 23, 2010******
Therefore, it took from March 23, 2010 to August 18, 2010 for them to get their 510k clearance! That comes out to about 5 months (aka 150 days - 30 x 5)! And if you notice, the FDA came out with questions and delayed the process somewhat as well. Doesn't that kind of sound familiar to you guys?
Bashers are going to say oh well IMGG has taken 3 years or whatever. You have to remember this is a new review team and a new submission that is interactively in communication with Dean Janes!
We are in excellent shape for approval guys! Let's cross our fingers for it to come any second now!
Good luck to all fellow IMGG'ers!
Here's a simple information sheet of Imaging3's ground-breaking technolgy...
http://www.warda.me/users/136/DViS%20Info.doc
No, the DViS is considered a Class 2 device (medium-risk). Many people blatantly throw the "PMA-route" reference out there when it comes to the Dominion's FDA 510k progress, but this is just misleading, false, and unnecessary. According to the text below, the DViS would definitely be classified as a Class 2 device which would only require a 510k marketing clearance with the FDA...
Device Classification
There are 3 FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, the risk to the patient and FDA regulatory control increases. Accessories to medical devices, devices used with a medical device to support use of the device, are considered the same classification as the medical device.
The FDA classification of medical devices is based upon classifications for devices currently legally marketed in the United States. The FDA determines the device classification by the device intended use and risk the device presents to the patient. New medical devices are compared to legally marketed medical device classifications with the same intended use and technological characteristics to determine the device classification.
Class I medical devices have the least amount of regulatory control. Class I devices present minimal potential harm to the user. Class I devices are typically simple in design, manufacture and have a history of safe use. Examples of Class I devices include tongue depressors, arm slings, and hand-held surgical instruments. Most Class I devices are exempt from the premarket notification and may be exempt from compliance with the good manufacturing practices regulation.
Class II medical devices are devices where General Controls are not sufficient to assure safety and effectiveness and existing methods/standards/guidance documents are available to provide assurances of safety and effectiveness. In addition to compliance with General Controls, Class II devices are required to comply with Special Controls. Special Controls include:
Special labeling requirements,
Mandatory performance standards, both International and United States
Postmarket surveillance
FDA medical device specific guidance
Class II devices typically require pre-market notification by submission and FDA review of a 510(k) clearance to market submission. A few Class II devices are exempt from the premarket notification. Information on Class II exempt devices is located within the device regulation, 21 CFR 862 through 892. Examples of Class II devices include physiologic monitors, x-ray systems, gas analyzers, pumps, and surgical drapes.
Class III medical devices have the most stringent regulatory controls. For Class III medical devices, sufficient information is not available to assure safety and effectiveness through the application of General Controls and Special Controls. Class III devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient. Typically a Pre-Market Approval (PMA) submission to the FDA is required to allow marketing of a Class III medical device. A few Class III medical devices are required to only have a 510(k) cleared by the FDA to be marketed. Examples of Class III devices that require a PMA are: replacement heart valves, silicone gel-filled breast implants, and implanted cerebella stimulators.
Also, there are no set deadlines with the FDA and 510k submission. Unfortunately this has taken a while, but we are still on track for approval I think fairly soon. I've justified the duration of time this has taken throughout this process by examining the following from the FDA's website...
510(k) Clearance to Market
The majority of Class II medical devices are cleared to market by submission and FDA review of a 510(k) Pre-Market Notification submission. The 510(k) submission identifies characteristics of the new or modified medical device as compared to a medical device with similar intended use, currently legally marketed in the United States. The currently legally marketed device is referred to as the “predicate” device.
The information required in a 510(k) submission is defined 21 CFR 807.87. A 510(k) submission includes:
Device trade or proprietary name, common or usual name or classification, Class of the device (Class I, II, III)
Submitter's name and address, Contact person, telephone number and fax number, Representative/Consultant if applicable
Name and address of manufacturing/packaging/sterilization facilities, Registration number of each manufacturing facility
Action taken to comply with the requirements of the Special Controls.
Proposed labels, labeling, and advertisements to describe the device, its intended use, and the directions for its use.
510(k) summary or a 510(k) statement.
For Class III medical device, a Class III certification and a Class III summary.
Photographs of the device, Engineering drawings of the device.
Identification of the marketed device(s) to which equivalence is claimed including labeling and description of the medical device.
Statement of similarities and/or differences with marketed device(s)
Data to show consequences and effects of a modified device, performance Data (bench, animal, clinical)
Sterilization information (as applicable)
Software development, verification and validation information
Hardware design and development information
Information requested in specific guidance documents (as applicable)
Kit Certification Statement (for a 510(k) submission with kit components only)
Truthful and Accurate Statement
Depending on the complexity of the new or modified medical device, the FDA Review of a 510(k) submission takes between 20 and 90+ days. The more complex the changes or comparison required to support the safety and effectiveness of the new or modified medical device, the longer the FDA review process.
I strongly believe that Imaging3 has made such a revolutionary product in the Dominion that they had to make many changes in order for this machine to be actually pretty unique compared to others, yet still derive from its predicate devices as far as equivalency is concerned. I think the FDA finally understands that this machine indeed is just a useful upgrade of the technology that currently exists and is approved by them.
The Dominion's predicate devices are the 9990 Plus Mobile Fluoroscopy System, and the LightSpeed 7.1 CT Scanner System (with many of the same/similar hardware components, but major changes in the software aspect).
Hopefully approval will come soon as we have all waited forever as it seems. However, among us all, Dean Janes has waited the longest and he will profit the most from this all. I certainly think he won't give up until this thing has passed the FDA's ultimate test.
I completely agree with this post. With the vast amount of uncertainty and the negative vibe that has been set by bashers on a constant and daily basis, we can expect the PPS to rocket. I definately don't believe this will be another CRXX. Approval day will have everyone jumping onboard as fast as they can. The volume will be huge; I'm guessing 25,000,000+. As long as we're still in the informal communication loop with the FDA instead of the formal loop then we're in good shape. Hopefully this week marks the end of the waiting, but we cannot predict anything related to timing anymore, as we have all learned a valuable lesson with the FDA's medical device submissions.
Great question mugs... As far as what I've gathered, this is my understanding. The FDA is reviewing not only the structure and design (hardware mechanics) of the DViS, but more importantly the data, output, and results of the experience the patient will potentially undergo using this medical device. They want to make sure the radiation levels are safe, whether the machine is set to 2/10th's of a second or up to 8/10th's of a second, etc... Dean's obligation is to show the clearest and best images he can possibly deliver to the FDA. Besides a whole packet of numerical data, he also sent them various types of images that the Dominion can process (import/export). Being that this device is a medical IMAGING device, this is obviously necessary. They didn't have any problems with the equivalent predecessor devices' images, however, they had a problem with SOME of the DViS's images. The "The %SYSTEMROOT%\System32\getaddrsbproc86.dll file is missing or damaged." error along with some others arose. For you computer guys, this dynamic-link library file is unique to the average computer and operating system. This is because the Dominion's software installs the proper support files in order to properly display the images constructed in a software image-viewing applet uniquely implemented by Imaging3. The DViS's exported image format contains the best quality resolution and picture display it has to offer. And this is what Dean tried showing them. I believe that he has corrected this issue with them and now they are able to open these and view them as the medical professionals would in the real world.
I don't think the clock has restarted at all because there wasn't a formal letter or 8-k filed. And I don't think we'll be waiting much longer (I know this statement is controversial because of the "3 year long wait"). But I guess time will tell.
And I'm pretty sure that Dean sent the previous FDA team's questions, responses, and answers just to clear up any issues from the past. This process has been a hundred times more miserable to Dean than any of the rest of us.
But nobody can argue with me that as soon as the FDA approves this device, and with all of the people waiting on the sideline mainly because of the bashing that created uncertainty, this stock will explode like a dynamite and bring back all of the people who were once shareholders of IMGG and more. IMO, the worst thing you can do is be one of those people because institutional buyers will hop in with millions of shares before any minions like us can grab ahold of anything.
Time will tell...
GLTU!
Thank you for clearing that up. I learned that too. Now this is what I call a constructive thread :).
Let's start one at a time here...
"What type of software language is use for programing the DVIS"
The Dominion's software and programming language consists mainly of C#.
"and how is the gantry control interfaced?"
As you can see the DViS as a whole, it's one machine. The gantry is controlled by a rotating arm at the bottom of the unit in which is dependant on the software obviously and user-controlled commands.
"Is this running under WIN7 or LINUX OS?"
The software will work on Windows 2000 and up including Windows 7. And there is also a platform compatible with the LINUX operating system including RedHat open source software.
"Does the gantry control operate via PLC that is controlled by DVIS software?"
See the answer above. And yes the arm that allows the rotation of the O-arm (which has the CCD video camera, xray image intensifier, xray source, and fluorescent screen are designed all programmable logic controlled.
"Like wise how is the emitter controlled?"
See above answer.
"What is file format that is used to view 3D images offsite?"
Animated .GIF in the simplest form, otherwise the unique file extension in which only the DViS understands. It can also export the video in flash (.swf) format based on the resolution settings and quality configured by the user. The highest quality will be the unique extension that the DViS is programmed to save by default though.
"IS there a DICHOM standard they adhere too?"
No. Everything is conventional. The only difference is that the DViS's capabilities was a patent that was surprisingly not taken yet. Therefore, Dean took advantage of this and created this machine.
You're welcome.
"Tom, you miss the point entirely!! The PPS is meaningless until we get FDA approval anyway! Edzevit must have deleted his earlier post or my comment would make more sense, those who have bet against IMGG/me or told IMGG/me we wouldn't or couldn't do something have been wrong!!" ~ Dean Janes 2010
These are some images provided to me that the Dominion Volumetric Imaging Scanner (DViS) produced in 3D. Imaging3 will finish this dreadful process with the FDA and there is no doubt that this technology will revolutionize the modern medical imaging device industry. Dean Janes has done a wonderful job of staying patient throughout this entire process. For those who continuously bash and question him, you must be so inconsiderate to negate all of his effort, energy, and time he has spent putting together this company, dream, and idea! The sad part is that he will one day make us all much wealthier than we already are, yet he continues being scrutinized daily. However, I'm not concerned for him at all, for he will have the final laugh and sense of pride!
IMGG's Dominion Volumetric Imaging Scanner (DViS) SKULL
IMGG's Dominion Volumetric Imaging Scanner (DViS) CERVICAL
IMGG's Dominion Volumetric Imaging Scanner (DViS) HAND
IMGG's Dominion Volumetric Imaging Scanner (DViS) LUMBAR
"Wow, never heard that before, oh wait yes I have, in 2003 they will never get the patent. I was approved in the first office action and all its claims. 2004 The patent is weak, then they allowed our continuation patent and all of its claims. They will never go public, oops that happened in 2005. They will never go above 0.20, that one from Mr Sano, my personal fav, we hit $1.95. Guess I'm just full of it, I guess this company isn't your "cup of tea" just be careful in calling me/it names just because it hasn't met your expectations!!!" ~ Dean Janes 2010
Be smart, GLTA! IMGG $5+!
The FDA had difficulties trying to understand where and what the corrections were that Dean had made. Therefore, to quickly prompt them through these changes to manuals, documents, etc, Dean sent in the package again but this time cross-referencing to the changes making it easier and faster for them to sort through. Remember these packages are 6-8 inches thick so what Dean did is is smart because it creates shortcuts straight to the changes in the submission. We can expect $5+ easy on approval any day now.
I don't hold anything against you or anyone but I'm just saying that what happened the other day REALLY hurt this board. I think everybody knows about it and now they don't trust IHub as they use to. People are comparing this board now to the Yahoo board which is totally insane. I use to frequently post on the Yahoo board until it became infested with misleading negativity and bashing. I just hope that this board doesn't end up being that way too. Other than that, I think you have done a good job in cleansing this board from inappropriate and off-topic posts.
Always classy IMGGorBust. I wonder how you do it!
Yeah Shaka honestly that bankruptcy post situaton REALLY hurt this board. IMGGorBust would be a great addition to the moderator team because he will conduct orderly and will get things straight.
Congratulations to IMGGorBust! You've been a great informant and now you have gained authority. Thank you for your great work!
12% up and counting! IMO we may see 20%+ today. Great day!
With all of the madess involved with IMGG's FDA poliics, once this thing clears (which it will eventually), we can expect this stock to rocket $5+. It's an intense wait but for the most of us it will be totally worth it when it comes. Now that being said, the people on the sidelines will be doing their best to jump in before it gets too high. The FDA can approve this any minute now because the clock was never formally restarted.
$0.30 is extremely cheap. These days are great buying opportunities. Some of you will kick yourself if you hesitate!
GLTA
LOOOL could be both
The reason why IMGG will explode on approval day is because of all the "uncertainty" the FDA has created due to all of the delays associated with the DViS. IMO ee can see at least $5. Buy now or buy high.
Brian Altounian: Hey buddy. Someone told me the number of bashers on the boards has increased considerably the last couple days. That's great news! See you soon.
ON FACEBOOK. The prophet has spoken! Approval is here!!
LOL... If it doesn't come by the end of this week, I'm going to fly out to South Africa and go streaking naked in the final world cup game. LET'S GO FDA!!!
I THINK WE'LL SEE JESUS BEFORE FDA APPROVAL. THIS IS TAKING FOREVER OH MY LORD!
Well it looks like it's time to load up gentlemen. FDA will be granting Imaging3 approval for their DViS machine. I want to put my money on Friday or the middle of next week sometime.
I recently received word from Mike that the company still remains positive and optimistic. Prepare for take off fellas.
According to http://imaging3.com/newsletters.html those are the dates we were able to come up with. Therefore, placing us in the same time-frame in which the FDA should be responding to us sometime next week with their answer... Hopefully on Monday we should be receiving an answer fom the FDA.
Calculating response from FDA
Based on the previous submission, Imaging3 sent in a response to the FDA on November 9th, and the FDA responded on January 11th. That equals 63 days for the FDA response. Based on that time frame, that would put this current response at June 7th. Just thought I would compare those dates...maybe history repeats itself.
- andy_invst @ yahoo
Dean is an orgaized man. I think this is it because he wants to prepare a video, news letter, and press release all at the same time to inform investors after receiving fda clearance what the next steps will be for the company. We will wait and see obviously, but either way you won't want to be out on the sideline come Monday morning.