ICUS Applauds FDA Modification of Boxed Warnings on Certain Ultrasound Contrast Agents; Cite Patient Benefit

WASHINGTON--(EON: Enhanced Online News)--International Contrast Ultrasound Society (ICUS) today applauded the FDA’s decision to modify the U.S. product label for DEFINITY® Injectable Suspension, an ultrasound contrast agent. Ultrasound contrast agents are approved in the U.S. for cardiac imaging and do not expose patients to ionizing radiation.

ICUS, a cross-specialty society of international medical experts, filed a Citizen Petition with the FDA in September asking the agency to remove boxed warnings from ultrasound contrast agents, stating that the warnings deter use of a safe, inexpensive and radiation-free diagnostic imaging tool with potential life-saving benefits for patients.

“The FDA decision should lead to increased use of contrast, better imaging studies, better diagnosis for patients, and saved lives,” according to Dr. Michael Main, an expert in contrast ultrasound safety and Treasurer of ICUS. Main is a cardiologist and director of the echocardiography laboratory at Saint Luke’s Mid-America Heart Institute in Kansas City.

Main said that although the FDA’s current boxed warnings for ultrasound contrast agents are not warranted by safety data, the label modification for DEFINITY® “makes important incremental progress based on sound science that now more accurately reflects the risk benefit profile.”

source: Business Wire

New Vascular Ultrasound Tables from Biodex

Biodex Medical Systems, Inc., Shirley, N.Y., will introduce two new vascular imaging tables at the Radiological Society of North America (RSNA) meeting in Chicago, November 27 to December 2, 2011. Excitement is building at the anticipation of new advancements in medical imaging; Biodex is thrilled to be part of the driving force for bringing new products to this field.

After an extensive research and development phase, the new Vascular Ultrasound Tables are ready to meet the demands of medical imaging. “We have been working hard to broaden our product line for our customers while also being on the forefront of the latest technologies for this industry with two new tables to choose from,” explained Rich Schubert, Radiology Sales for Biodex Medical Systems, Inc.

The Vasc Pro Vascular Ultrasound Table can be described as the best solution for any type of long leg vascular procedure including Venous mapping, DVT, Venous ablation, PAD and many more procedures. The Vasc Pro is also an economical choice when performing vascular scanning. The table design will also help improve images by providing a 30-degree reverse Trendelenburg position. The table is considered so accommodating that it reduces the total amount of time required to achieve image quality. The 30-degree position expands lower extremity veins for maximum vessel dilation as well as faster and easier recognition of structures.

The new Echo/Vasc Pro Vascular Ultrasound Table is the logical choice when performing vascular scanning and echocardiography, to view arteries, veins and heart chambers. The Echo/Vasc Pro provides the same convenient solutions to these procedures as the Vasc/Pro while also providing the same ergonomic benefit as our popular Echo Pro table. As always, ergonomics is the key ingredient in all Biodex Ultrasound tables. Sonographer safety and optimal imaging potential makes Biodex tables the first choice of most facilities.

source: PR Web

Abnormal Brain Ultrasounds in Premature Infants Indicate Future Risk of Psychiatric Disorders

Infants born prematurely are at risk for injuries to the white and gray matter of the brain that affect cortical development and neural connectivity. Certain forms of these injuries can be detected in the neonatal period using ultrasound, according to Columbia University Medical Center researchers.

Researchers who followed a group of premature infants until age 16 found that those with neonatal ultrasound abnormalities were at increased risk for specific psychiatric disorders, namely, attention deficit hyperactivity, tic disorders, obsessive compulsive disorder, and major depression―all of which are thought to arise from dysfunctions of the subcortical-cortical circuits. The findings were published in the July 2011 issue of the Archives of General Psychiatry.

Premature birth is a growing problem in the United States, adding to the significance of the findings. An increased appreciation of the relation between perinatal brain injuries and later psychiatric disorders could lead to earlier diagnosis and intervention by the pediatricians, psychiatrists, and neurologists who care for these children and adolescents. Future research may also explore the relation of perinatal brain injury to psychiatric disorders, such as schizophrenia, that more commonly come to clinical attention in adulthood.

A research group at Columbia University Medical Center/New York State Psychiatric Institute led by Dr. Agnes Whitaker, MD, evaluated more than 400 nondisabled adolescents who had been born prematurely and had had abnormal brain ultrasounds taken at birth. When the researchers administered questionnaires and cognitive tests to the subjects and interviewed their parents, they found a relation between perinatal brain injuries and certain psychiatric disorders at adolescence that could not be explained by other medical or social factors.

source: Columbia University Medical Center

Volcano Corporation to Supply Intravascular Ultrasound Technology to Covidien

Volcano Corporation (NASDAQ: VOLC), the leading developer and manufacturer of precision guided therapy tools designed to enhance the treatment of coronary and peripheral vascular disease, today announced the signing of a supply agreement with ev3, a Covidien company, under which Volcano will supply its proprietary Intravascular Ultrasound (IVUS) technology for use in ev3's Plaque Excision Systems. Utilizing the digital IVUS transducer incorporated in Volcano's market leading EagleEye® catheter product line, this new product will be capable of running on Volcano's global installed base of 5,000 systems.

"At Volcano, our imaging and physiology tools provide a level of precision that angiography alone simply cannot match," commented Scott Huennekens, President and CEO of Volcano. "In addition to our internally developed image guided therapy products, such as the VIBE® RX Imaging Balloon (commercially available in the EU only), we have looked to other medical device industry leaders to join us in differentiating therapeutic devices by adding integrated imaging capabilities. Covidien is an innovative company that recognizes the value of onboard visualization and is committed to bringing these new, more precise therapies to market to help improve patient outcomes. This agreement also exemplifies the value of our one system, many solutions strategy facilitated by our multi-modality platform."

source: Volcano

Surgeons Get FIT for Breast Health with Terason Ultrasound

BURLINGTON, Mass.--(BUSINESS WIRE)--Terason, the innovator and leader in laptop ultrasound technology today announced the release of the Terason t3200™ Ultrasound System – Breast Series. This fully-functional, portable ultrasound system is the first of its kind designed specifically for the Breast Surgeon.

David Kaufman, Chief of Breast Surgery at St. Joseph’s Hospital in Bethpage, NY stated, "The Terason t3200 is a dedicated Breast Ultrasound system that is truly in a class by itself, with state-of-the-art digital quality imaging in a portable laptop format that is fully integrated into an Apple MacBook Pro. Simply stated, the Terason t3200 is a unique system that not only is a fully functional laptop PC, but is a fully equipped ultrasound system as well. This unique feature, seen only in this Terason unit, will allow any physician to streamline their workflow, allowing more time to provide diagnostic and interventional ultrasound to their patients. One can scan and store images and reports directly on the laptop, plus they can be e-mailed directly to referring physicians. The image quality is outstanding and far superior compared to other laptop-style ultrasound units. In short, the Terason t3200 is easy to use and inexpensive to purchase. This system stands alone as best in category.”

The t3200 Breast Series is the second release in a family of Terason systems with a new wave of advancements in ground-breaking technology. FIT, exclusively from Terason, provides Flexible Imaging Technology using innovative new features to produce high quality images and simplify the ultrasound exam. All new X-Site™ Transducers and DDR™ provide top-notch image quality in both superficial and deeper targets to further enhance clinical confidence. A re-designed intuitive interface, with simplified measurements and annotations, will increase productivity and patient throughput.

source: Business Wire

ContextVision Unveils New Cutting Edge Ultrasound Image Enhancement Product Family

BOSTON, Mass. and STOCKHOLM, Sweden – April 11, 2011 – At the American Institute of Ultrasound in Medicine (AIUM) Annual Convention this week, ContextVision, the software imaging partner for the most recognized medical imaging manufacturers worldwide, will unveil its cutting-edge ultrasound image enhancement family, US PLUSView™. This modular family enables equipment manufacturers to deliver a full range of ultrasound image enhancement capabilities to their customers, including deeper penetration and improved speckle reduction features for the obese and other technically difficult patients.

Following the global obesity epidemic, an increasing portion of all abdominal scans is considered technically difficult since obesity impacts the clinicians´ ability to interpret ultrasound images. ContextVision has designed the US PLUSView product family to extend ultrasound imaging capabilities for these patients. The US PLUSView family includes a modular series of products that offer leading-edge diagnostic capabilities for the clinicians. The unique US PLUSView product family sets new standards as it enables directed, focused image enhancement (DFE) of selected areas, depths and intensities without sacrificing overall image quality.

source: Cision Wire

TechniScan's Breast Imaging Science Featured at National Ultrasound Conference

SALT LAKE CITY, April 11, 2011 /PRNewswire/ -- TechniScan's (OTC BB: TSNI) novel breast ultrasound technology and clinical results will be featured at the American Institute of Ultrasound Medicine's annual conference in New York this week.

As part of an educational session on advanced breast ultrasound imaging, Michael Andre, Ph.D., director of an ongoing clinical study at the University of California, San Diego Moores Cancer Center that enlists TechniScan's automated Warm Bath Ultrasound (WBU) technology, will be leading the discussion and explaining the latest results of the WBU ultrasound system.

TechniScan's WBU system not only employs the well-known properties of reflection ultrasound but also maps the breast by sending transmission ultrasound waves through it, which significantly improves the clinical information and may allow a radiologist to determine whether a breast lesion is a cyst, a benign fibroademona or a malignancy – without a biopsy.

Two of the world's leading experts on transmission ultrasound and the mathematics of inverse scattering, James Wiskin, Ph.D., a TechniScan founder and adjunct professor at the University of Utah Department of Bioengineering, along with his colleague David Borup, Ph.D., are co-authors on the study. Wiskin will also be participating in the New York session.

"This conference is a great opportunity for other physicians and scientists to learn of the scientific and medical advances the TechniScan system demonstrates," said Andre.

source: PR Newswire

Toshiba Introduces Enhancements On Its Ultrasound Product Line To Improve Cardiac Diagnostic Capabilities

Ultrasound is often used as a first-line diagnostic exam to quickly and safely diagnose a range of patient conditions. At this year's American College of Cardiology (ACC) annual meeting in New Orleans, April 2 - 5, 2011 (Booth # 2847), Toshiba America Medical Systems, Inc., will highlight new enhancements to its cardiac and shared service ultrasound systems that are designed to enhance cardiac ultrasound imaging.

"Toshiba is dedicated to continuously improving its imaging systems to meet the changing needs of healthcare providers," said Tomohiro Hasegawa, director, Ultrasound Business Unit, Toshiba. "These enhancements to the ultrasound product line build upon Toshiba's advanced technology to allow quicker, safer and more effective diagnosis, particularly for cardiac exams."

New enhancements include:

- 3D Wall Motion Tracking and Tissue Enhancement for the Aplio Artida
- Auto IMT on Toshiba's Shared Service Ultrasound Systems
- New TEE Probe

source: Toshiba Medical

BK Medical Introduces Revolutionary Advanced Robotic Ultrasound Technology (ART) for Prostate Imaging at European Association of Urology Congress

PEABODY, Mass., March 24, 2011 (GLOBE NEWSWIRE) -- BK Medical, a wholly owned subsidiary of Analogic Corporation (Nasdaq:ALOG), introduced Advanced Robotic Ultrasound Technology™ (ART™), the industry's first complete ultrasound imaging solution for robotic surgery. This revolutionary technology, which includes the Flex Focus™ 700 Ultrasound System, specialized transducers, and tools designed specifically for robotic-assisted surgery, was introduced at the 20th Annual European Association of Urology (EAU) Congress in Vienna, March 18-22. ART is a premium performance ultrasound solution that may benefit surgeons performing robotic-assisted radical prostatectomy (RARP) procedures, and robotic-assisted partial nephrectomy (RAPN) procedures.

"BK Medical has been working closely with a leading robotic-assisted surgery company, along with surgeons, to develop the ART ultrasound solution to address robotic-assisted surgery needs of today and tomorrow," said Michael Brock, president of BK Medical. "ART technology, the result of this successful collaboration, provides clinicians with a valuable tool to assess and monitor robotic-assisted surgery procedures in real time."

BK Medical

Bedside Ultrasound Becomes a Reality

(NewDesignWorld Press Center) - Clinicians have often referred to ultrasound technology as the "stethoscope of the future," predicting that as the equipment shrinks in size, it will one day be as common at the bedside as that trusty tool around every physician's neck. According to a new report in The New England Journal of Medicine, that day has arrived.

The "Current Concepts" article by Yale School of Medicine clinicians Christopher L. Moore, M.D., and Joshua A. Copel, M.D., outlines how ultrasound use has moved beyond traditional specialties like radiology and is now being routinely employed by clinicians across myriad medical specialties and practice areas. From anesthesia to vascular surgery, Moore and Copel say, the use of ultrasonography has increased across the board, with the biggest growth seen among non-radiologists.Over the past two decades, the equipment used in ultrasonography-a safe, effective and non-invasive form of imaging that aids in diagnosis and guides procedures-has become more compact, higher quality and less expensive, leading to the growth of point-of-care ultrasonography, which is performed and interpreted by the clinician at the bedside.

"Ideally, point-of-care ultrasonography can decrease medical errors, provide more real-time diagnosis, and supplement or replace more advanced imaging in appropriate situations," said Moore, assistant professor in the Department of Emergency Medicine at Yale School of Medicine. "Point-of-care ultrasonography may also allow more widespread, less expensive screening for certain illnesses."

source: NewDesignWorld

Conceptus(R) Receives CE Mark for Transvaginal Ultrasound Confirmation for Essure(R) Procedure

MOUNTAIN VIEW, Calif., Feb. 24, 2011 (GLOBE NEWSWIRE) -- Conceptus Inc. (Nasdaq:CPTS), developer of the Essure® procedure, the most effective non-surgical permanent birth control method available, today announced receipt of the CE mark for use of Transvaginal Ultrasound ("TVU") to confirm proper placement of Essure micro-inserts three months following the Essure procedure. TVU is an alternative to the standard flat plate pelvic X-ray, and both will be included in the European Physicians' Instruction for Use. TVU takes place in the physician's clinic, while X-rays typically are taken at a radiology facility.

Essure micro-inserts are radiopaque, which enables physicians to visualize the location of the micro-inserts using either TVU or the standard flat plate pelvic X-ray. TVU is a non-invasive technique that uses sound waves sent out by an ultrasound probe to create a live picture (a sonogram) showing the reproductive organs. TVU advantages for patients include the ability to return to the familiar setting of the physician's clinic and avoid ionizing radiation associated with X-rays. TVU advantages for physicians include more control over the entire Essure procedure and improved patient compliance with the confirmation process.

source: Conceptus

Toshiba Announces FDA Clearance of Auto-IMT Ultrasound Software

TUSTIN, Calif.--(BUSINESS WIRE)--For physicians, the ability to streamline exams for determining a patient’s risk for cardiovascular disease is important in determining the patient’s clinical pathway. To enhance diagnostic efficiency, Toshiba America Medical Systems, Inc. has introduced Auto-IMT™, an ultrasound software tool that can measure the thickness of the intima-media layers of the carotid artery, for evaluating an asymptomatic patient’s risk of developing cardiovascular disease. Toshiba has recently received FDA clearance for Auto-IMT, and it is now available on the AplioTM XG, Aplio MX and XarioTM XG ultrasound systems.

“Toshiba is committed to improving patient care and providing ways to streamline processes so patients receive the highest quality care more efficiently.”

Toshiba’s Auto-IMT can determine the thickness of the near and far arterial walls from three segments of the carotid artery: at an optimal angle of incidence and two complementary planes. Auto-IMT traces the two complementary planes automatically and calculates the distance between them. The Auto-IMT uses the collected images following the American Society of Echocardiography’s (ASE) consensus statement for the diagnosis.

Toshiba worked with Midwest Ultrasound, a division of The Christ Hospital in Cincinnati, Ohio, to develop the software tool. Midwest Ultrasound is a nationally recognized leader in providing quality cardiac and vascular ultrasound services, and maintains a diverse client mix, from small rural and community hospitals to major urban academic centers and large physician practices in southwest Ohio.

source: Business Wire

Toshiba Receives FDA Clearance for Viamo Ultrasound System

TUSTIN, Calif., Feb. 4, 2010 – Designed to meet the needs of today’s hospitals by combining portability with high-end radiology features, Toshiba America Medical Systems, Inc.’s new ViamoTM laptop ultrasound system has received FDA clearance. The Viamo is the industry’s no-compromise ultrasound system with advanced radiology capabilities, previously unavailable on hand-carried systems. Toshiba’s Viamo provides the best value in the hand carried class by offering the same premier image quality as larger, more expensive ultrasound systems, but at a lower price point for hospitals. The Viamo was introduced at the 2009 Radiological Society of North America (RSNA) annual meeting.

The Viamo combines the portability of a laptop system with advanced radiology features to deliver outstanding image quality, enhance diagnostic confidence and improve ease of use. Developed from a radiology foundation, Toshiba’s Viamo provides the confidence to image patients at bedside, which generally requires larger, more expensive cart-based systems. When an immobile patient needs a high-end ultrasound exam, the portable Viamo ultrasound is brought to the patient to improve the patient’s comfort without compromising exam quality. It is also ideal for a variety of patient exams, including general radiology, pediatric, emergency, OB/GYN and vascular.

source: Toshiba Medical Systems

Ultrasound fusion imaging provides comparable accuracy for bone, soft tissue tumors

DETROIT – Biopsies using ultrasound fusion imaging for detecting bone and soft tissue cancers are safe, effective and just as accurate as conventional biopsy methods, according to a Henry Ford Hospital study.

Researchers found that the ultrasound fusion imaging technique guides a needle biopsy with precise accuracy and ease, while making the biopsy experience more convenient for patients.

Ultrasound fusion merges real-time ultrasound images with previously acquired computed tomography or magnetic resonance imaging scans, providing physicians with high resolution, life-like imaging to identify the area for biopsy.

This is the first time researchers compared the safety and efficacy of ultrasound fusion against conventional biopsy imaging tools like CT or MRI.

The study's findings will be presented at the annual meeting of the American Academy of Orthopaedic Surgeons Feb. 15-18 in San Diego.

"Ultrasound fusion is a viable option to consider for patients," says Michael Mott, M.D., an orthopaedic oncologist at Henry Ford and principal investigator for the study. "With imaging precision being equal, patients liked the ultrasound fusion because scheduling a biopsy was found to be more flexible for ultrasound suites than CT suites."

source: EurekAlert

Terason Makes it Easy for MSK Ultrasound to get FIT

BURLINGTON, Mass.--(BUSINESS WIRE)--Terason is transforming the way Musculoskeletal Ultrasound is performed with the new Terason t3200™ Ultrasound System – the first fully-functional, portable ultrasound system designed specifically for the MSK professional.

The t3200 MSK Series is the first in a family of Terason systems with a new wave of advancements in ground-breaking technology. FIT, exclusively from Terason, provides Flexible Imaging Technology using innovative new features to produce high quality images and simplify the ultrasound exam. All new X-Site™ Probes and DDR™ provide top-notch image quality in both superficial and deeper targets to further enhance clinical confidence. A re-designed intuitive interface, with simplified anatomy-specific exam measurements and annotations, will increase productivity and patient throughput.

Terason is proud to ship the first t3200 MSK Ultrasound System to Andrews Institute in Gulf Breeze, FL, a world-class institute for Orthopaedics and Sports Medicine.

source: Business Wire

Worlds First Smartphone Based Ultrasound Imaging System Cleared by the FDA

Mobisante, Inc., a privately held medical device company located in Redmond, WA, announced today that it has received 510(k) clearance from the FDA for its smartphone based ultrasound imaging system, MobiUS.

MobiUS is an innovative mobile, affordable, and accessible ultrasound imaging system that uses a smart-phone and Internet cloud services based commercial ultrasound system.

The MobiUS system is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary and specialty care. Since MobiUS is based on smartphones it can leverage cellular networks or Wi‐Fi to send images to a remote expert for diagnosis or second opinion, or to a Picture Archiving and Communication System (PACS) for storage.

“Meeting the FDA’s of review is a critical milestone for Mobisante. We will now focus on launching MobiUS in selected markets and pursuing the CE mark in Europe”, said Dr. Salesh Chutan, CEO and co-founder of Mobisante.

MobiUS puts ultrasound capabilities into the hands of healthcare providers everywhere. This immediate access is especially important in rural communities in the U.S.A. and abroad that have limited resources, low population density, or are located far from the urban centers.