Navigation Links
Imaging Diagnostic Systems Updates PMA Filing Status for the New CT Laser Breast Imaging System
Date:11/27/2007

Secures 10th U.S. Clinical Site

FORT LAUDERDALE, Fla., Nov. 27 /PRNewswire-FirstCall/ -- Imaging Diagnostic Systems, Inc., (OTC Bulletin Board: IMDS) a pioneer in laser optical breast imaging, announced today that the Company has secured its 10th U.S. clinical site to participate in its CTLM(R) clinical trials. Under an approved protocol, the sites are collecting patient studies for the eventual submission of a Premarket Approval (PMA) application to the Food and Drug Administration.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040412/IMDSLOGO )

"We are very pleased to have achieved our goal of 10 clinical sites. The CT Laser Mammography (CTLM(R)) system promises to add significant adjunctive value to current mammography practices," stated Deborah O'Brien, IDSI Senior Vice President. "While we have performed over 13,000 CTLM breast exams internationally, we have elected to utilize only those cases collected in the U.S. under our approved PMA clinical trials protocol. We may also include two additional U.S. clinical sites to further shorten the time needed to collect the prescribed number of confirmed cancer and non-cancer cases to be used for the statistical analysis as a major component of our PMA application."

O'Brien continued, "Upon completion of the data collection phase, we will conduct an image interpretation or 'reading' phase where CTLM scans and conventional mammography exams will be read adjunctively by specially trained radiologists. That data, along with confirmed biopsy results, will then be analyzed according to our primary and secondary intended uses by an outside biostatistical firm. Their results will be submitted to King and Spalding, who will assist in our preparation of the final PMA application. Unlike IDSI's prior PMA application, the new PMA application will not be submitted in the modular form, although IDSI
'/>"/>

SOURCE Imaging Diagnostic Systems, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Siemens Preclinical Imaging System Helps The Methodist Hospital in Houston Further Its Research Mission
2. Imaging Diagnostic Systems CTLM Technology Presented at Congress of World Society for Breast Health
3. Xenomics Announces Implementation of its First Diagnostic Test for Acute Myeloid Leukemia Into Clinical Practice
4. Quest Diagnostics Introduces ClariSure(TM) Test for Identifying Chromosome Abnormalities Associated With 85 Developmental Disorders in Children
5. Strategic Diagnostics Launches Initial Oncology-Targeted Antibody Reagent Catalog
6. Virogenomics, Inc. Awarded $2 Million National Institute of Standards and Technology (NIST) Advanced Technology Program Grant to Develop Integrated Diagnostic Biosensors
7. Abbotts m2000(TM) Molecular Diagnostic Instrument and RealTime HIV-1 Test Win Chicago Innovation Award
8. Roche Diagnostics HIV Viral Load Test Used in Clinical Trials for Isentress, a New Class of HIV Drug
9. Two Point of Care Tests From Quest Diagnostics Receive FDA 510(k) Clearance
10. Video: Quest Diagnostics Health Trends(TM) Report Shows Significant Gap in Care for Patients With Chronic Kidney Disease
11. Xenomics Announces Issuance of a US Patent That Covers Use of Transrenal Nucleic Acid Technology for Infectious Disease Diagnostics and Monitoring
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... recently published clinical study conducted at TOPS Comprehensive Breast ... that 3D mammography (breast tomosynthesis) significantly reduces unnecessary recalls ... study, "Implementation of Breast Tomosynthesis in a Routine Screening ... Stephen L. Rose , MD, and published in ... Roentgenology (AJR). The AJR is the scientific journal ...
(Date:5/23/2013)... IRVINE, Calif. , May 23, 2013 ... breast cancer may not benefit from chemotherapy and still ... announced the launch of one of the largest sources ... The new website and interactive Facebook page provide recently ... if they can safely avoid chemotherapy. "We ...
(Date:5/23/2013)... , May 23, 2013  Every day, their baby ... air to his lungs. April and Bryan Gionfriddo ... predictions weren,t true. "Quite a few doctors said ... alive," says April Gionfriddo , about her ... Anything that would work, we would take it and run ...
Breaking Medicine Technology:First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 2First Large-Scale U.S. Study Validates the Benefits of 3D Mammography (Breast Tomosynthesis) Exams 3Agendia Launches Social Media Campaigns to Help Breast Cancer Patients with Chemotherapy Decisions 2Agendia Launches Social Media Campaigns to Help Breast Cancer Patients with Chemotherapy Decisions 3Baby's life saved with groundbreaking 3D printed device from U-M that restored his breathing 2Baby's life saved with groundbreaking 3D printed device from U-M that restored his breathing 3Baby's life saved with groundbreaking 3D printed device from U-M that restored his breathing 4
... 6, 2011 Pacira Pharmaceuticals, Inc. (Nasdaq: ... today announced that it has entered into agreements ... Commercialization Services, Inc. (ICS) to support the anticipated ... should it be approved by the Food and ...
... 5, 2011 Reportlinker.com announces ... report is available in its ... Aesthetics (Botox, Dermal Fillers, Collagen) ... Landscape and Market Forecasts to ...
Cached Medicine Technology:Pacira Pharmaceuticals, Inc. Expands EXPAREL™ Commercial Team Infrastructure 2Pacira Pharmaceuticals, Inc. Expands EXPAREL™ Commercial Team Infrastructure 3Pacira Pharmaceuticals, Inc. Expands EXPAREL™ Commercial Team Infrastructure 4Pacira Pharmaceuticals, Inc. Expands EXPAREL™ Commercial Team Infrastructure 5Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 2Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 3Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 4Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 5Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 6Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 7Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 8Facial Aesthetics (Botox, Dermal Fillers, Collagen) - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017 9
(Date:5/24/2013)... 2013 Started in 1982, AMTC’s SHINE event ... 2013 marks AMTC’s 31st anniversary. SHINE is a ministry run ... Millie Lewis and her daughter, Carey Lewis Arban. , This ... directors, and music professionals including the New York Film Academy, ... They are kings of Hollywood and Christian casting directors. They ...
(Date:5/24/2013)... 2013 The nation’s first trial of ... Inc.’s da Vinci Surgical System concluded yesterday, Bernstein Liebhard ... State Court jury ruled in a 10-to-2 decision that ... who performed a da Vinci prostatectomy on a patient ... had alleged in their lawsuit that the da Vinci ...
(Date:5/24/2013)... Mike Stoler believes that there is ... people in New York. That’s why he hosts ... CUNY TV. And that’s why he invited Robert ... LLP (ENTA)—the largest single specialty practice in the greater ... and audiology specialists and sub-specialists service communities throughout New ...
(Date:5/24/2013)... CA (PRWEB) May 24, 2013 According to ... on Facebook: Social Media Leads to Spikes in Plastic ... there is a growing prevalence of facial plastic surgery ... media. These people have become keenly aware of the need ... sites such as Facebook, Google and even Skype's video chat ...
(Date:5/24/2013)... in five parents think they have little control over ... drug use, a new U.S. government survey finds. ... and Mental Health Services Administration (SAMHSA), since new research ... influential forces helping to shape their child,s views on ... that parents can make an enormous difference in influencing ...
Breaking Medicine News(10 mins):Health News:AMTC’s Summer SHINE Event Coming to Orlando’s Luxurious Gaylord Palms July 2-7, 2013 2Health News:Da Vinci Robot Lawsuit News: Bernstein Liebhard LLP Comments on Verdict in Nation’s First Trial Involving Alleged Da Vinci Complications 2Health News:Da Vinci Robot Lawsuit News: Bernstein Liebhard LLP Comments on Verdict in Nation’s First Trial Involving Alleged Da Vinci Complications 3Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 2Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 3Health News:Robert Glazer, Chief Executive Officer of ENT and Allergy Associates, LLP®, Talks About the Business of Succeeding in New York 4Health News:Facebook and Google – Is Social Media Driving Demand for Plastic Surgery? 2Health News:Parents Underestimate Influence Over Teens' Substance Abuse: Survey 2
... of Hollywood actress Katie Holmes, has declared that she will ... ,The 18-year-old fashion student, who has infuriated Katie, ... days 15 hours 12 minutes and 40 seconds. ... porn star. Katie is well known as she has fathered ...
... It seems that Hollywood hunk Brad Pitt is enjoying parental bliss ... the pregnant Myleene Klass at Cannes, Pitt poured his heart out ... have had your first scan yet? They're mind-blowing. Get ready to ... - it's the best thing that ever happened to me,' the ...
... majority of chemotherapy errors identified in children reach patients, ... cancer drug errors in children . Published in the ... of the American Cancer Society, the study concluded that ... associated with errors, and that errors in drug administration ...
... scare over soft drinks is in the making following revelations that ... Pepsi Max has the ability to switch off vital parts ... when parts of DNA are disabled, as it were, it could ... as Parkinson's. ,Concerns centre on the safety of E211, ...
... 2007 graduates of the Yale School of Forestry & Environmental ... or develop renewable energy in order to offset the pollution ... on Memorial Day. ,The 131-member class will spend ... carbon dioxide, which is equivalent to the combined weight of ...
... one of the largest ever Parkinson's disease (PD) clinical ... can slow the symptom progression of this disorder. ... in which patients develop tremor, slowness of movements and ... people in the U.S. Currently, there are a number ...
Cached Medicine News:Health News:Most Pediatric Chemotherapy Mistakes Reach Patients 2Health News:Soft Drink Additive Could Cause Cell Damage 2Health News:Soft Drink Additive Could Cause Cell Damage 3Health News:Yale F&ES Graduation to Offset Gas Linked to Global Warming 2Health News:Emory Participates in Study to Slow Progression of Parkinson's Disease 2
... The Trans-Blot SD semi-dry ... and economical blotting. Using a ... anode and a stainless steel ... Trans-Blot SD cell transfers in ...
Semi-Dry Blotting Unit for 10 x 10cm Gels...
... Transfers depurinated DNA and RNA from ... little as 15 minutes ,Increases speed and ... to be applied to gel ,Part of ... transfer and UV crosslinking in 2.5 hours, ...
... from agarose gels to hybridization membranes in ... and efficiency of transfer by allowing high ... of an integrated system allowing electrophoresis, gel ... hours, versus 29 hours required for conventional ...
Medicine Products: