Navigation Links
Digirad Corporation Receives FDA 510(k) Clearance for nSPEED(R) Reconstruction Software for Improved Image Quality in Less Time With Less Radiation
Date:9/22/2008

To Market Imaging Systems Using New Software That Enables SPECT Procedures

That Meet New ASNC Technology Standards

POWAY, Calif., Sept. 22 /PRNewswire-FirstCall/ -- Digirad Corporation (Nasdaq: DRAD), a leading provider of diagnostic imaging systems and services to physicians' offices, hospitals and other medical services providers, today announced it received from the U.S. Food and Drug Administration (FDA) 510(k) clearance for its new nSPEED(R) reconstruction software -- for reduced imaging time and improved image quality with less radiation exposure for patients -- to be used in its imaging systems for SPECT procedures at either half-time and/or half count densities with parallel and non-parallel hole collimators.

SPECT (single photon emission computed tomography) systems are commonly used to perform a non-invasive test to assess the heart's structure and function.

For example, with nSPEED, Digirad Cardius solid-state dedicated cardiac systems can now perform cardiac SPECT imaging procedures in as little as three minutes or with one-half the required pharmaceutical dosages. Supporting 510(k) documentation submitted to the FDA was based on data obtained from a 448-patient, 10-center evaluation using Digirad's single, dual and triple-head Cardius cameras.

Digirad Chief Executive Mark Casner stated: "Our nSPEED software represents a new benchmark for performing nuclear SPECT studies that meet the new standards recently issued by the American Society of Nuclear Cardiology. In addition, with nSPEED which is an advanced 3D-OSEM reconstruction program, the acquisition times for, and count densities of, cardiac SPECT images represent a 50 percent improvement over specifications in prior ASNC guidelines."

On June 18, 2008, the American Society for Nuclear Cardiology (ASNC) issued new technology-standards for SPECT image acquisition and processing. This standard stated, "For new software methods specifically designed for reduced acquisition times and/or lower count density images, cardiac count density should be in accordance with that specified in or implicit to the method's 510(k) FDA approval."

About Digirad

Digirad Corporation provides diagnostic nuclear and ultrasound imaging systems and services to physicians' offices, hospitals and other medical services providers for cardiac, vascular, and general imaging applications. Digirad's Cardius XPO line of nuclear imaging cameras use patented solid-state technology and unique multi (dual, triple) head design for superior performance and advanced features for sharper digital images, faster processing, compact size, lighter weight for portability, ability to handle patients up to 500 pounds, and improved patient comfort compared to standard nuclear cameras. Digirad's 2020tc general-purpose nuclear imager has a small footprint and may also be configured for fixed or mobile use to supplement primary imaging. Digirad's installed base of equipment exceeds 550 systems; in addition, a mobile fleet of 164 nuclear and ultrasound imaging systems is being used in 22 states and the District of Columbia, primarily in the eastern, midwestern and southwestern United States. For more information, please visit http://www.digirad.com. Digirad(R), Digirad Imaging Solutions(R), and Cardius(R) are registered trademarks of Digirad Corporation.

Forward-Looking Statements

Statements in this press release that are not a description of historical facts are forward looking statements. You can identify these statements by the fact that they do not relate strictly to historical or current facts and use words such as "anticipate," "estimate," "expect," "project," "intend," "plan," "believe" and other words and terms of similar meaning. Examples of such forward looking statements include statements regarding improvements in performance and results of actual use. Actual performance, results and benefits results may differ materially from those set forth in this press release due to risks and uncertainties inherent in the use of new technology, working conditions, work force, and use of Digirad's camera systems and services, reliability, recalls, and other risks detailed in Digirad's filings with the U.S. Securities and Exchange Commission, including Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Form 8-K and other reports. Readers are cautioned to not place undue reliance on these forward looking statements, which speak only as of the date hereof. All forward looking statements are qualified in their entirety by this cautionary statement, and Digirad undertakes no obligation to revise or update the forward looking statements contained herein.

Investor Contact: Company Contact:

Dan Matsui Todd Clyde, CFO

Allen & Caron 858-726-1600

949-474-4300 ir@digirad.com


'/>"/>
SOURCE Digirad Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Digirad Corporation Reports Financial Results for 2008 Second Quarter and Six Months
2. Digirad Corporation to Present at CapStone Small-Cap Investor Conference
3. Digirad Corporation to Present at Bank of America 2008 Health Care Conference
4. Digirad Corporation and University of Chicago Medical Center Sign Letter of Agreement
5. Digirad Corporation Reports Financial Results for First-Quarter 2008
6. Digirad Corporation to Release First Quarter Financial Results on April 24, 2008
7. Digirad Corporation Appoints John W. Sayward to Its Board of Directors
8. Digirad Corporation to Release Fourth Quarter, Year-End Financial Results on February 7, 2008
9. Digirad to Introduce New Clinical Standard for Cardiac SPECT
10. Digirad Corporation Board of Directors Appoints R. King Nelson Chairman
11. Digirad Corporation and The Methodist Hospital in Houston Sign Letter of Agreement
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... ... athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic procedures as ... City area —Johnson is one of the first doctors to perform the treatment. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
(Date:6/24/2016)... ... June 24, 2016 , ... Global law firm Greenberg Traurig, ... Elite. The attorneys chosen by their peers for this recognition are considered among the ... Traurig Shareholders received special honors as members of this year’s Legal Elite Hall of ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their ... Award, an essay contest in which patients and their families pay tribute to a ... the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, LLC (SCP) ... obtaining investment capital for emerging technology companies. SCP has delivered investment events ... in more than a million dollars of capital investment for five companies. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016  Consumers have taken a more active ... more emphasis on patient outcomes. ... the pharmaceutical industry have evolved beyond just providing ... are focusing on becoming more patient-oriented across their ... services that improve health. ...
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... The Academy of Managed Care Pharmacy (AMCP) ... would allow biopharmaceutical companies to more easily share health ... and coverage decisions, a move that addresses the growing ... The recommendations address restrictions in the sharing of ... label, a prohibition that hinders decision makers from accessing ...
Breaking Medicine Technology: