Acusphere Announces Results of FDA Advisory Committee Meeting

Acusphere, Inc. (NASDAQ: ACUS) today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration advised that the diagnostic benefit of contrast enhancement using Acusphere's ImagifyTM (Perflubutane Polymer Microspheres) for Injectable Suspension is not sufficient to justify the risks associated with the product. The vote was sixteen against, one in favor and one abstention. The Committee also discussed concerns that they would like addressed to support approval of the product for the detection of coronary artery disease.

"We appreciate the support Imagify has received from a wide variety of cardiologists, who are eager for FDA to enable them to use the drug in their practices to improve accessibility, reduce costs and avoid exposure to radiation," said Sherri C. Oberg, President and CEO, Acusphere. "We continue to believe in Imagify for its intended purpose and will work with FDA through the completion of the review process to determine what additional information might be required for approval."

The Advisory Committee's recommendations, while not binding, will be considered by the FDA in its review of the New Drug Application (NDA) of Imagify. The expected FDA target action date for Imagify under the Prescription Drug User Fee Act (PDUFA) is February 28, 2009.

source: Acusphere

ICON Medical Imaging Launches New Cardiac Echocardiography Analysis Software

DUBLIN, December 10 /PRNewswire-FirstCall/ -- ICON plc (NASDAQ: ICLR)(ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that its Medical Imaging division has launched a new cardiac echocardiography analysis software solution. The software, MIRA-ECHO, enables cardiac echocardiography (ECHO) images to be viewed, measured and interpreted in clinical trials and is the latest addition to ICON Medical Imaging's proprietary MIRA(TM) (Medical Imaging Review and Analysis) platform.

Dr. Jonathan Goldman MD, Chief Medical Officer at ICON Medical Imaging, and a recognised expert in echocardiography commented: "MIRA-ECHO satisfies an important unmet need in clinical trials that involve ECHO. For the first time we have a solution that allows us to adjust and fine-tune traced cardiac measurements stored in the eCRF against a moving source image, whilst maintaining regulatory compliance and an audit trail. Combining MIRA-ECHO to the existing MIRA-QCA module for quantitative coronary angiography allows us to offer clients unparalleled capabilities for cardiovascular assessments."

source: PR Newswire

Ultrasound screening helps prevent stroke in children with sickle cell disease

Screening with an ultrasound machine has proved highly successful in preventing stroke among children with sickle cell disease, by identifying children who are then preventively treated with blood transfusions. Over an eight-year period at The Children's Hospital of Philadelphia, researchers found that the technique, transcranial Doppler ultrasonography (TCD), along with regular transfusions for children found to be at high risk, reduced stroke to one-tenth of the incidence found before TCD was introduced.

"We studied the impact of using TCD starting in 1998, when the technique became routine at our hospital and many other centers," said Janet L. Kwiatkowski, M.D., a pediatric hematologist at The Children's Hospital of Philadelphia. Kwiatkowski presented her group's results today at a press conference during the 50th annual meeting of the American Society of Hematology.

Childhood stroke has long been known to be a devastating complication of sickle cell disease, an inherited condition in which abnormal hemoglobin deforms red blood cells into sickle-shaped bodies that do not pass smoothly through blood vessels.

TCD is a noninvasive tool that uses ultrasound waves to measure the speed of blood flow in large vessels in the brain. An abnormally high speed is a marker of a narrowed vessel, and a sign of high risk for stroke.

source: EurekAlert

Ultrasound Transducer Disinfection in many Cases insufficient - New ‘Trophon EPR’ Device offers unique Solution

(openPR) - Hamburg, December 5, 2008: Current methods of ultrasound transducer disinfection are in many cases not sufficient for clinical practice. This is the latest alarming result issued by the Center for Disease Control and Prevention (CDC), the leading US public health agency, in its recently published Guideline for Disinfection and Sterilization in Healthcare Facilities (1). The guideline is the CDC’s response to the rapidly evolving epidemiology of hospital-acquired infections such as Clostridium difficile (2) or MRSA (3).

In light of this global threat, and with regard to the millions of ultrasound examinations conducted each day, Nanosonics’ newest product innovation represents a long-needed milestone in the development of medical devices: due to its unique technology, the Trophon EPR completely satisfies all requirements of the new CDC guideline.

source: openPR.com

Toshiba Showcases New Women's Ultrasound Imaging Techniques and Transducer at RSNA

CHICAGO, Nov 30, 2008 (BUSINESS WIRE) -- To help improve diagnostic confidence in breast imaging and women's health, Toshiba America Medical Systems, Inc. has developed a new and exclusive ultrasound technique - MicroPure(TM), which helps physicians detect breast lesions and micro-calcifications more clearly. In addition, Toshiba will also be showcasing its new 18 MHz high resolution Dynamic Micro Slice transducer for breast imaging, its quantitative sonoelastography suite, ElastoQ (works-in-progress), and Spatio-Temporal Image Correlation (STIC). Toshiba will showcase these advances at this year's Radiological Society of North America (RSNA) annual meeting in Chicago, Nov. 30 - Dec. 5, 2008 (Booth #3429, South Hall).

"Increasing the ability to use ultrasound to image the breast is a significant development," said Gordon Parhar, director, Ultrasound Business Unit, Toshiba. "We believe these advances will benefit many women across the country."

source: MarketWatch

SonoSite Announces the New S-GYN™ A Specialized Ultrasound Tool for Gynecologists

Bothell, WA, December 1, 2008 - SonoSite, Inc. (Nasdaq:SONO), the world leader and specialist in hand-carried ultrasound for the point-of-care, introduced today the S-GYN™ ultrasound tool, a streamlined, custom-designed solution for gynecologists who want to perform imaging for diagnosis and procedural guidance right in the patient exam room.

“I have two great big machines in my office, but for a lot of what I’m doing in my day-to-day practice, such as evaluating abnormal bleeding, checking the ovaries or uterine structures for polyps or fibroids - I can do all that with the S-GYN without having to move my patient out of the exam room,” said Shaunie Keys, MD of Evergreen Women’s Care, in Kirkland, WA. “A big advantage of the S-GYN system is its portability and that I don’t have to disrupt work flow by shuffling patients to different rooms or interrupt my ultrasound tech’s schedule. It’s easy to learn and provides really good imaging. My patients feel more confident knowing that I will complete the ultrasound exam and they will have their results before leaving the office.”

source: SonoSite

Hitachi Ultrasound Highlights Elastography Capabilities at RSNA Annual Meeting

At this year’s RSNA Annual Meeting in Chicago, Hitachi Medical Systems America will demonstrate advances for the HI VISION™ 900 system as well as unique probe-based solutions, which allow radiology departments to utilize the equipment in their department more efficiently.

A highlight of its exhibition is new developments in Hitachi’s Real-time Tissue Elastography (E-mode) feature. Hitachi reported, with over 800 units delivered, Hitachi’s E-mode is now being used for applications other than just breast imaging. The company will display images of its use in thyroid, prostate, musculoskeletal and colorectal applications. Its new Strain Ratio tool allows Radiologists to quantify the relative differences in stiffness between a mass and any surrounding tissue.

source: Welt Online

GE Healthcare Introduces Ultrasound Fusion; New LOGIQ E9 Merges Real-Time Ultrasound With CT, MR, and PET

MISSISSAUGA, ON, Nov. 24 /CNW/ - GE Healthcare today
announced the launch of a new ultrasound system for
radiology and vascular applications that fuses
ultrasound images with images from other imaging
modalities like CT and MR.The new LOGIQ(R) E9
includes Volume Navigation, an innovative tool which
incorporates two key components to maximize the
system's new agile ultrasound architecture: 'Fusion'
to combine the advantages of real-time ultrasound
imaging with the high spatial and contrast resolution
of CT, MR or PET; and a 'GPS-like technology' to
track and mark a patient's anatomy during the
ultrasound exam, bringing confidence and productivity
to both diagnostic and interventional studies.

"GE's new LOGIQ E9 helps address the biggest
challenge in ultrasound radiology and vascular care
- how to leverage clinical images from previous
diagnostic imaging studies for interventional or
diagnostic ultrasound procedures," said Terri
Bresenham, GE's Global VP, Diagnostic Ultrasound and
Information Technology. "We worked closely with a
global team of radiologists and sonographers to
develop this new ultrasound architecture, giving
clinicians the advantages of imaging modalities -
MR, CT and PET - and it is already reigniting the
imagination of the ultrasound industry."

source: CNW Group

Pocket-Sized Echocardiograph Provides Quick And Qualitative Assessment

The European Journal of Echocardiography* recently published a paper studying the performance of Siemens' ACUSON P10™ ultrasound system at the Morriston Cardiac Centre in Swansea. Results revealed that the P10 was, within a four minute examination, able to assess the size and function of the left ventricle in more than three quarters of cardiac patients.

Images obtained by the P10 were assessed on the ability to provide information on whether or not the left ventricle, left atrium, aortic and mitral valves were 'grossly normal' or 'grossly abnormal'. There were no instances of the bedside scan missing a significant finding that was then detected with alternative methods of imaging. Furthermore, in two cases, results from the P10 scan had an immediate impact on the clinical management of a cardiac patient.

source: Medical News Today

Siemens Integrates ARFI Imaging Into Ultrasound

Siemens Healthcare is presenting one of the most innovative technologies for its Acuson S2000 ultrasound system at the Medica from November 19 – 22, 2008 in Duesseldorf, Germany.

The Virtual Touch Tissue Imaging and Virtual Touch Tissue Quantification applications are the first commercially available implementations of ARFI (Acoustic Radiation Force Impulse). Similar to a physical palpation exam, these leading-edge applications represent a new dimension of diagnostic information by interrogating the mechanical strain properties or stiffness of tissue, which may be correlated with pathology.

Both applications are particularly suited to evaluating liver tissue. Additional fields of use – such as in prostate diagnosis – are currently clinically validated.

source: Innovations Report

Oregon Institute of Technology Acquires Toshiba Aplio Artida 4D Ultrasound System

TUSTIN, Calif., Nov 11, 2008 (BUSINESS WIRE) -- To offer its students access to the most advanced medical technology available, Oregon Institute of Technology (OIT) has acquired the Toshiba Aplio(TM) Artida 4D ultrasound system. The acquisition of the advanced ultrasound system will make OIT the first undergraduate program in the United States to offer courses in 4D ultrasound imaging.

"Our goal is to train OIT students using the newest, most advanced technology to prepare them for high-tech, high-demand careers in healthcare," explained OIT's Brad Burda, acting provost and interim dean, School of Health, Arts and Sciences. "By using the Artida, one of the most advanced 4D ultrasound systems available, our students will gain the comprehensive skills necessary to meet today's healthcare demands."

source: MarketWatch

ACUSON S2000 showcased at leading museum of modern medicine

Siemens Healthcare recently supported the Leeds and Bradford Ultrasound Study Day at the Thackray Museum in Leeds, one of the UK’s leading medical museums. Delegates listened to various talks from eminent speakers on liver and obstetric imaging plus received an informative presentation on the ACUSON S2000™ ultrasound system.

Not only does the ACUSON S2000 provide excellent image quality in difficult to image patients, it also includes innovative applications to improve diagnostic confidence. Applications such as Virtual Touch™ Quantification use Acoustic Radiation Force Impulse (ARFI) technology to compress tissue and provide qualitative and quantitative assessment of its stiffness. This application can be utilised anywhere in the body, however its main clinical advantage is currently in the evaluation and quantification of liver stiffness.

The ACUSON S2000 also provides best-in-class foetal imaging for 2D and 3D / 4D acquisition. Its Spatio-Temporal Image Correlation (STIC) feature enables an automated acquisition of a high quality foetal heart volume, using a sophisticated algorithm that compensates for variability in heart rate. This enables doctors to obtain detailed volumes of the foetal heart for more accurate diagnosis. The S2000 also benefits from advanced knowledge-based workflow applications such as syngo® Auto OB measurements to improve diagnostic confidence and enhance workflow.

source: Siemens

Ultrasound helps predict heart attacks in "low risk" patients

HOUSTON -- (November 10, 2008) -- By adding the results of an imaging technique to the traditional risk factors for coronary heart disease, doctors at Baylor College of Medicine in Houston found they were able to improve prediction of heart attacks in people previously considered low risk.

The findings are being presented today at the American Heart Association's Scientific Sessions in New Orleans.

Researchers used ultrasound imaging to view the carotid intima media thickness (C-IMT), or thickness of the artery walls.

"The ultrasound added another dimension to the risk factor score and showed us that those with thick arteries in the higher end of low risk group actually are at intermediate risk for coronary heart disease," said Dr. Vijay Nambi, assistant professor of medicine - atherosclerosis and vascular medicine at BCM and lead author of the study.

source: Baylor University College of Medicine

National Association Endorses Recommendations for Contrast Agent Use in Heart Ultrasounds (Echocardiograms)

MORRISVILLE, N.C., Nov 04, 2008 /PRNewswire via COMTEX/ -- American Society of Echocardiography Lays out Clinical Applications and Safety Considerations

The American Society of Echocardiography (ASE) today backed the use of contrast agents, used to enhance echocardiogram images, and provided a guide for physicians who may be hesitant to use the contrast agents following a 2007 Food and Drug Administration (FDA) black box warning. In a new statement, supported by expert consensus opinion, critical review, and evidence-based research, ASE outlines why, when and how the contrast agents should be used to enhance diagnosis, the role for each person in the lab, and methods to implement contrast in the lab. The statement, "The American Society of Echocardiography Consensus Statement on the Clinical Applications of Ultrasonic Contrast Agents in Echocardiography," was released in the November 2008 issue of The Journal of the American Society of Echocardiography.

source: MarketWatch

Misonix Subsidiary, Sonora Medical Systems, Announces a Major Ultrasound Probe Study

FARMINGDALE, N.Y., Nov 04, 2008 /PRNewswire-FirstCall via COMTEX/ -- Misonix, Inc. today announced that its Sonora Medical Systems subsidiary ("Sonora Medical"), a leading supplier of after market products, services and test equipment to the medical imaging market, presented an ultrasound probe study in Sweden at the country's annual clinical engineering meeting recently held in Goteborg, Sweden. The paper was presented by the School for Technology and Health, the Royal Technical University, the Biomedical Engineering Department of Karolinska University Hospital and the Department for Clinical Physiology of Karolinska University Hospital and was titled "Defective ultrasound transducers in Swedish hospitals." The presentation from this study can be downloaded at www.4sonora.com.

Using the Sonora FirstCall probe testing system the authors tested 704 probes in clinical use from 30 hospitals representing 7 ultrasound manufacturers. The authors found that 39.8% of the transducers tested had functional failures and that there was no statistical difference in the number of probe failures discovered on systems under service contract or not on service contract.

source: MarketWatch

DRE Adds Affordable Refurbished Ultrasound Machines to Product Line

DRE, Inc. — named by Business First of Louisville as one of the fastest-growing businesses in Louisville, Ky. — now sells professionally refurbished ultrasound machines. DRE’s extensive lineup of affordable ultrasound machines includes systems from many popular brands, including GE, Siemens/Acuson, Philips, HP and Medison.

Refurbished ultrasound machines from DRE are designed for a variety of study areas, including cardiac, OB/GYN and vascular ultrasound studies. Dependable ultrasound systems for each study-type are available from DRE in portable and mobile stand-alone options.

Each refurbished ultrasound system sold by DRE is put through a multi-point inspection and biomedical engineering process. Each ultrasound machine is reconditioned to be as close as possible to the standards of the original equipment manufacturer.

source: DRE