Wednesday, April 30, 2008

Acusphere Submits New Drug Application for FDA Approval of Imagify(TM)

WATERTOWN, Mass., Apr 28, 2008 (BUSINESS WIRE) -- Acusphere Inc. (NASDAQ: ACUS) announced today the submission of a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for approval to market its lead product candidate, Imagify(TM) (Perflubutane Polymer Microspheres for Injectable Suspension). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States. The NDA includes data from studies of Imagify in more than 1,000 patients worldwide, including two pivotal international multi-center Phase III clinical trials, RAMP-1 and RAMP-2 (Real-Time Assessment of Myocardial Perfusion).

Imagify is the first ultrasound imaging agent designed to assess blood flow in the heart (myocardial perfusion), a sensitive marker of coronary artery disease. The Company believes it is also the first ultrasound imaging agent to demonstrate in large clinical trials clinically equivalent accuracy to nuclear stress testing, the current standard for assessing myocardial perfusion. Currently, perfusion information is not available using cardiac ultrasound, but must be obtained using a nuclear stress test, an expensive and time-consuming test that involves injecting the patient with a radioactive imaging agent. More than 10 million stress imaging procedures are done each year in the U.S. to detect coronary artery disease.

source: Acusphere

Tuesday, April 29, 2008

European Ultrasound Markets Embrace New Technologies

LONDON--(BUSINESS WIRE)--Advancements in obstetrics and gynaecology ultrasound, hand-carried ultrasound as well as other smaller market segments such as urology and surgical ultrasound are driving the European ultrasound market.

New analysis from Frost & Sullivan (, European Markets for Ultrasound, finds that the market was worth $0.9 billion in 2007 and estimates this to reach $1.4 billion in 2014.

“Increased demand from private practitioners as well as the growing number of breast and prostate ultrasound procedures will boost market growth,” notes Frost & Sullivan Research Analyst Krishanu Bhattacharjee. “With the use of hand-carried ultrasound units for the anaesthesia and emergency wards, the European market for ultrasound is set to experience sustained growth.”

With revolutionary advances in technology, particularly in the form of miniaturisation of transducer probes, elastography as well as 3D and 4D imaging, the market is poised to grow at a steady rate in the coming years.

source: Business Wire

Thursday, April 24, 2008

3-D Ultrasound Could Improve Stroke Diagnosis and Care

Durham, NC -- Using 3-D ultrasound technology they designed, Duke University bioengineers can compensate for the thickness and unevenness of the skull to see in real-time the arteries within the brain that most often clog up and cause strokes.

The researchers believe that these advances will ultimately improve the treatment of stroke patients, whether by giving emergency medical technicians (EMT) the ability to quickly scan the heads of potential stroke victims while in the ambulance or allowing physicians to easily monitor in real time the patients’ response to therapy at the bedside.

The results of the latest studies were reported online in the journal Ultrasound in Medicine & Biology. The research was supported by the National Institutes of Health and the Duke Translational Medicine Institute, with assistance from the Duke Echocardiography Laboratory.

source: Duke University

Wednesday, April 23, 2008

Emerging Ultrasound Market to Grow Rapidly Over Next Five Years

April 23, 2008—Waltham, Massachusetts—According to Millennium Research Group’s US Markets for Ultrasound Systems 2008 report, the emerging ultrasound market will experience rapid growth over the next five years. Increasing at a compound annual growth rate of over 15% from 2007 to 2012, this market, composed of ultrasound systems used for regional anesthesia, emergency medicine, surgery, and critical care, will exceed $306 million by 2012 (excluding upgrade and service revenues).

The affordability and improving performance of compact systems have made ultrasound increasingly popular in nontraditional environments such as critical care units. Compact systems weigh 15 pounds or less, providing convenience and mobility to physicians. Manufacturers of these systems have fostered growth in emerging markets by tailoring new compact systems to include specific applications that ease system operation for health care providers who are inexperienced with ultrasound.

source: Millenium Research Group

Tuesday, April 22, 2008

Bacterial Contamination Detected In Ultrasound Gels

A study conducted by M. Eyigor and colleagues (Turkey), presented at the 18th European Congress of Clinical Microbiology and Infectious Diseases in Barcelona, has demonstrated the contamination of sonographic transducers, which can result in outbreaks of hospital infection. All the gels in the hospital were collected to exclude bacterial contamination.

A total of 669 unopened bottles of gels from two different brands were sampled for cultures. In one of the brands - the most expensive one (6€ per bottle) - no bacterial growth was observed in 364 bottles sampled, so these gels were distributed back to the hospital. A total of 305 bottles of the second brand - the cheapest one (1€ per bottle) - were investigated and in 222 (72.8%) of these, bacterial contamination was detected.

source: MedicalnewsToday

Monday, April 21, 2008

Ultrasonix Medical Corporation Credits a Great 2008 Start to EPI Extended Pulse Imaging Technology - a Significant Advance in Diagnostic Ultrasound

RICHMOND, British Columbia, April 21 /PRNewswire/ -- Ultrasonix Medical
Corporation Ltd. Announced a substantial growth for the first quarter of
2008, with a 20% increase in revenue over the same period in 2007. The
company attributes its strong growth to new advances on the award winning
Sonix OP and Sonix SP systems as well as substantial market growth in the
Emergency Medicine market.

Increased sales for the Sonix OP and Sonix SP platforms can be largely
attributed to a new breakthrough technology, EPI Extended Pulse Imaging.
EPI uses a special signal technology that improves penetration and
maintains image quality in technically difficult patients. Previously this
type of technology was only available on premium ultrasound systems. Now
clinicians have a more cost-effective alternative to use in a range of
applications including abdominal, gynecological, and obstetrical imaging.

source: PR Newswire

Thursday, April 17, 2008

New 3D Imaging Technology Reveals Heart's 'Unanswered Questions'

DALLAS, TX--(Marketwire - April 17, 2008) - Cardiovascular surgeons and anesthesiologists at Presbyterian Hospital of Dallas have begun using a new type of echocardiogram that provides the first-ever live 3D images of the beating heart moments before surgery. The technology is expected to help surgeons better determine the course of open-heart surgeries and better treat people with heart failure, one of the leading causes of death in the United States.

"Ultrasound imaging is beneficial because it is a relatively non-invasive way to look inside the body," said Dr. Melvin Platt, medical director of cardiovascular surgery at Presbyterian Hospital of Dallas. "But until now those images left many unanswered questions. There's no question this technology adds a whole new dimension to what we're able to see."

source: MarketWire

Sunday, April 13, 2008

Mammography Plus Sonography Can Help Rule out Breast Cancer in Patients with Palpable Lesions

When mammography and sonography are used together to evaluate palpable breast lesions, they can rule out cancers in most patients, according to a recent study conducted by researchers at Baystate Health in Springfield, MA. However, uncommonly, malignancies cannot be diagnosed using this imaging protocol.

“We were interested in finding out just how effective mammography and sonography were, when used together, in excluding breast cancer in women with palpable findings,” said Erica Tyler, MD, lead author of the study. “Our study differs from others because after enrollment, we followed patients for at least 3 years to see if any of the palpable lumps later were diagnosed as malignant,” she said.

The study evaluated 414 palpable breast lesions using both mammography and sonography. Imaging of 167 lesions was negative, with normal appearing breast tissue in the area of clinical concern and no mammographic or sonographic findings to explain the palpable finding. Among the 167 women with negative mammography and sonography, 120 reached a diagnostic endpoint with 28 patients undergoing a biopsy that showed no malignancy and 92 patients showing no malignancy after follow-up of at least 36 months. There were 118 true-negative and two false-negative cases said Dr. Tyler. The NPV when using mammography and sonography together was 98%, she said.

source: ARRS Press Release

Saturday, April 12, 2008

Newly Diagnosed Breast Cancer Patients Benefit from Use of Ultrasound-guided Fine Needle Aspiration of Lymph Nodes

Newswise — Ultrasound-guided fine needle aspiration (USFNA) of the lymph nodes is a safe, useful, and minimally invasive procedure for diagnosing metastatic disease in patients who are undergoing preoperative staging for breast cancer, according to a recent study conducted by researchers at the Rhode Island Hospital/Warren Alpert Medical School of Brown University in Providence, RI.

“We wanted to determine which patients with newly diagnosed breast cancer would benefit most from preoperative fine needle aspiration of the axillary lymph nodes,” said Martha Mainiero, MD, lead author of the study. “This quick and minimally invasive procedure can assist the surgeon in determining what type of axillary surgery is best for patients with breast cancer. Unfortunately many centers do not routinely perform this procedure as there is not yet consensus on who will benefit from it,” she said.

source: Newswise

Friday, April 11, 2008

Siemens Launches Dedicated Ultrasound And Women's Health Team - New Offering To Provide A One-stop Approach To Breast Imaging Solutions

Siemens has announced the creation of an Ultrasound and Women's Health division to promote and support its products and services within the UK healthcare marketplace.

Mammography and ultrasound are playing an increasingly important role in the detection and diagnosis of breast disease. Breast cancer is the most common cancer in women in the UK*, however, thanks to increased awareness and extending screening services, early detection and diagnosis has boosted survival rates.

The creation of the new dedicated team follows comprehensive customer research and is in response to the evolving breast care environment. "The introduction of new applications and techniques such as elastography, silicon transducers and tomosynthesis has called for detailed and specialist advice in the marketplace," said Andrew Pattison, Director of Diagnostic Ultrasound & Women's Health at Siemens

source: MediLexicon

Monday, April 7, 2008

Philips HD7 ultrasound system now commercially available in the United States

ANDOVER, Mass.--(BUSINESS WIRE)--Royal Philips Electronics (NYSE: PHG, AEX: PHIA) today announced that the latest addition to its HD ultrasound family of products, the Philips HD7, has launched in the United States. The Philips HD7 was introduced to Europe in March at the European Congress of Radiology (ECR) in Vienna. The system draws upon an array of features and capabilities available on high-end Philips systems and puts them into an affordable, mobile unit that is well-suited for a wide variety of clinical settings.

The system provides grayscale and color Doppler imaging with simple one button optimization, as well as Tissue Harmonic Imaging. In addition, the HD7 features a wide array of transducers, an adjustable flat panel LCD monitor, proven system architecture, and advanced imaging, measurement and quantification technologies.

source: Yahoo Finance

Friday, April 4, 2008

Siemens Showcases World's First Pocket Ultrasound System at the International Conference on Emergency Medicine 2008

SAN FRANCISCO, April 4, 2008 /PRNewswire/ -- Siemens Healthcare ( highlights its smallest ultrasound solution -- the ACUSON P10(TM) ultrasound system -- at the International Conference on Emergency Medicine (Booth #300), April 3-6, 2008 in San Francisco.

The ACUSON P10 handheld diagnostic ultrasound system is a little larger than a common PDA, weighs only 1.6 pounds, and fits easily into a lab coat pocket. It delivers on demand ultrasound imaging and is intended for complementary initial diagnostic care and triage, particularly in emergency care, cardiology and obstetrics.

"Instead of having to rush the patient to the technology, the P10 system brings the technology to the patient. This can save critical minutes, especially when a patient is in cardiac distress or with trauma patients, who have multiple injuries," said Dr. Eyal Herzog, FACC, director of the Cardiac Care Unit at St. Luke's-Roosevelt Hospital Center, in New York, an early ACUSON P10 system user. "The application flexibility and portability of the ACUSON P10 pocket ultrasound system mark significant changes in the way emergency care is administered, changes that could alter the face of the physical exam and, ultimately, lead to better patient outcomes."

source: Rehab Management

Wednesday, April 2, 2008

Mindray's Laptop-size M5 and BS-200 Receive FDA Clearance

SHENZHEN, China, March 31, 2008 /Xinhua-PRNewswire via COMTEX News Network/ -- Mindray Medical International Limited (NYSE: MR) today announced it has received 510(k) clearance from the United States Food and Drug Administration ("FDA") for its portable M5 ultrasound imaging system and BS-200 automatic bio-chemistry analyzer. Mindray has to date received FDA 510(k) clearance for a total of 14 products, covering patient monitoring and life support products, in-vitro diagnostic products and medical imaging systems.

The company also announced it has received approval from the Chinese State Food and Drug Administration ("SFDA") for the M5 and its DC-3 color ultrasound imaging system and provided an update on its product approval pipeline.

source: Mindray

Benefits Of Ultrasound Contrast Agents Outweigh Potential Risk To Heart Patients

A Saint Louis University cardiologist called upon the U.S. Food and Drug Administration (FDA) to reconsider a strong warning it recently placed on a diagnostic tool, stating that the warning could prevent doctors from detecting life-threatening cardiac events.

In October 2007, the FDA placed a black box warning on ultrasound contrast agents, which are used to improve the quality of echocardiography images in patients who do not otherwise have optimal images, after receiving reports of four deaths and serious reactions shortly after or during the infusion.

A black box warning is given to drugs that carry a significant risk of serious or even life-threatening adverse effects. The warning placed on ultrasound contrast agents was issued without a formal examination of the risks and benefits of using them, says Melda Dolan, M.D., associate professor of cardiology at Saint Louis University School of Medicine.

source: Medical News Today

Tuesday, April 1, 2008

GE's Transformation Of Cardiovascular Ultrasound Continues At ACC

GE Healthcare, a global ultrasound leader, continues to re-invent and re-imagine the technology behind its success, addressing the growing demand for cardiac imaging at the point of care. At this year's meeting of the American College of Cardiology (ACC) in Chicago, GE Healthcare is launching its latest ultrasound system designed to deliver excellent performance and breakthrough technology. The all-new, mobile, streamlined Vivid S5 cardiovascular ultrasound system has been designed as a dedicated cardiovascular solution for various care areas, from the hospital and clinic to the operating room to the physician's office, in a practical, easy to use design.

By leveraging GE Healthcare's miniaturization expertise gained from the compact Vivid i, the performance expertise of the console Vivid 7 and the proven utility and versatility of the Vivid 4, GE introduces a new concept and performance level for its ultrasound consoles. In the vein of the Vivid S6 signature class cardiovascular ultrasound system, introduced at the American Heart Association meeting last fall, the Vivid S5 delivers strong performance, excellent image quality and innovative design. Its stress echo capabilities and raw data DICOM expand the reach of patient examinations.

source: MedicalNewsToday