Replies to post #11486 on Imaging Diagnostic Systems (fka IMDS)

[~ Blue ~]

lol, IMDS Securing FDA Approval for DOT


Feb 09, 2012 (Close-Up Media via COMTEX) --
Imaging Diagnostic Systems, Inc., ("IDSI") a provider of laser based Diffuse Optical Tomography (DOT) for breast cancer detection, announced that it remains fully committed to securing FDA approval. The company is in the process of submitting a PMA application to the FDA.
Linda Grable, Chairman and CEO of IDSI said "After years of developing a truly unique and non-invasive breast imaging technology, we are pleased to be recognized as "Diffuse Optical Tomography." In addition, as possibly the first DOT breast imaging modality to seek FDA approval, we are completely dedicated to meeting all of the FDA requirements as quickly as possible."
Mrs. Grable goes on to state that: "IDSI"s management team remains focused on providing shareholder value. Management is presently investigating several long term financing strategies that will both maintain and increase shareholder value and achieve our FDA objectives. IDSI understands that there have been some unidentified and uncontrollable forces putting pressure on our stock price. IDSI is a late stage research and development company that currently has various international registrations and approvals. CTLM (Computed Tomography Laser Mammography) is being used daily by doctors in those markets as a non invasive breast imaging modality. Our ultimate goal is to provide this technology and its benefits to women in the United States."
Dr. S. Ponder Director, Advanced Development for IDSI said "We continue to be encouraged by our clinical study results. Especially, when dealing with heterogeneous and extremely dense breasts. We have been able to demonstrate that CTLM increases detection sensitivity especially in Extremely Dense Breast (BIRADS classification), when compared to x-ray based mammography. The CTLM examination is performed without breast compression, x-ray radiation, or contrast injections. In addition, the non-invasive and non-radiation patient benefits of CTLM could become a very important future clinical benefit especially now that many breast screening programs are under significant scrutiny."
((Comments on this story may be sent to [e-mail]))

Copyright Close-Up Media, Inc. 2012. All Rights reserved

http://www.imds.com/news/

[~ Blue ~]

IMDS has FDA export Certification for enabling sales in international markets.

http://www.imds.com/ctlm/Regulatory-Status.php


FDA is supporting IMDS-CTLM passed some test of FDA that is why they gave FDA Export certification

here information about what is FDA CERTiFICATION

What are FDA Export Certificates?

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a "certificate" for products regulated by the Food and Drug Administration (FDA). A certificate is a document prepared by FDA containing information about a product's regulatory or marketing status.

Why do foreign governments want FDA Export Certificates?

In many cases, foreign governments are seeking official assurance that products exported to their countries can be marketed in the United States or meet specific U.S. regulations, for example current Good Manufacturing Practice (cGMP) regulations. Review of an FDA Export Certificate may be a required part of the process to register or import a product into another country.


MUCH MORE HERE

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=76594528

[jmurfk]

This old information serves hype purposes only. When there is nothing hype worthy for years, you have to rely on very old info. The more recent facts, like info from filings, is avoided to the extreme, or the meaning is twisted. This was done on the RW filings. They were going to register shares to convert debt. The SEC had questions on the filing. I guess IMDS did not want to respond, so they issued unregistered shares via rule 144, and filed an RW filing to withdraw the original S-1. They had to amended the RW filing 3 times.

After those 4 filings, which was a single filing amended three times, folks began hyping IMDS, claiming the SEC was canceling all the shares from the 4 filings added together, lmao. This was one of the most warped interpretations of a penny stock filing that I've ever seen.

[~ Blue ~]

THERE ARE many REASONS, MUST READ

1) Scientific American is a well known Science magazine in the world. That is why that article is very important for me as an investor. Scientific American doesn't make news or article for scams.

2) CTLM accepted by FDA as a DOT device another big mile stone for me as an investor of this stock. Very good sign for getting Pre-Market Approval from FDA.

3) FDA gave them Export Certification, that is another good sign for me as well . Again that is another good sign to INVEST.

4) FDA approval just for sales in the USA. If they get They can sell in USA but for overseas the company doesn't have problem to sale internationally. Until now they sold 18 devices.

5) The company holds, IS0 certification, CE marking( accepted 32 countries in Europe), China, Russia and Canada Certification. So those certifications is enough for sale CTLM internationally. So the company wants to increase those sells. They made agreement with Mexico last December to sell 5 CTLM. The company send 1 and 4 of them preparing to send.

6) For increasing international sales you need distributors. So in May, 2012 the company added 2 new distributors. Kuwait Mareen Group, Japon Shimadzu. Both of them big companies. Shimadzu is in the business since 1875, a billion dollars company.

7)I made some research, in Russaia CTLM market 2.5 billion dollars. In USA 4.5 billion dollars. In Europe 8 billion dollars. dON'T KNOW CHINA MARKET, I GUESS IT MUST BE BIGger THAN USA. The company sold 1 CTLM to China. It takes time for the company to be known internationally.

8) the company holds 35 patents, 20 in usa 15 internationally. I made my dd before investing this stock.

9) It tales time for the company 19 years battle to be known in medical field.
Either case they will sale and they are selling CTLM.

So for all those reasons i invested here. i am long, i will not flip or use this as day trade. I don't care daily share price. I know we will see 5-10 even 20 upticks in a day.

we will see cents even dollar levels. This stock has high potential of gain.


HAPPY WEEKEND