Toshiba Launches New Cardiac Ultrasound Syaytem at ACC

SAN FRANCISCO, March 8, 2013 – To help clinicians more accurately and efficiently diagnose cardiovascular disease, Toshiba America Medical Systems, Inc. introduces the AplioTM 500 and Aplio 300 CV ultrasound systems. Compact and easy-to-use, Aplio 500 CV and Aplio 300 CV deliver exceptional image quality and advanced technologies to improve patient diagnoses and treatment.

Both the Aplio 500 and 300 CV are the systems of choice for all premium 2D cardiac exams and feature Toshiba’s 2D Wall Motion Tracking technology, which provides stunning visualization and quantitative analysis of myocardial wall motion with unrivaled accuracy and reproducibility. With on-board cardiac quantification measurements in all directions (radial, circumferential, 2D rotation and longitudinal), the Aplio CV systems are designed to get the most comprehensive information anytime and anywhere in the hospital, right at the patient’s bedside.

Additional cardiac-specific technologies include Tissue Enhancement, Advanced Dynamic Flow™, Lateral Gain Controls, Tissue Doppler, Stress Echo, Flex-M Mode and Auto IMT. Both systems are easy to use, with superior ergonomics and a smaller footprint, making them easier to maneuver for greater patient access and improved workflow.

source: Toshiba

Texas A&M research contributes to improved ultrasound imaging

Ultrasound technology could soon experience a significant upgrade that would enable it to produce high-quality, high-resolution images, thanks to the development of a new key material by a team of researchers that includes a professor in the Department of Biomedical Engineering at Texas A&M University.

The material, which converts ultrasound waves into optical signals that can be used to produce an image, is the result of a collaborative effort by Texas A&M Professor Vladislav Yakovlev and researchers from King's College London, The Queen's University of Belfast and the University of Massachusetts Lowell. Their findings appear in the current issue of "Advanced Materials."

The engineered material, known as a "metamaterial," offers significant advantages over conventional ultrasound technology, which generates images by converting ultrasound waves into electrical signals, Yakovlev explains. Although that technology has advanced throughout the years – think of the improvement in sonogram images – it is still largely constrained by bandwidth and sensitivity limitations, he says. These limitations, he adds, have been the chief obstacle when it comes to producing high-quality images that can serve as powerful diagnostic tools.

The metamaterial developed by Yakovlev and his colleagues is not subject to those limitations, primarily because it converts ultrasound waves into optical signals rather than electrical ones. The optical processing of the signal does not limit the bandwidth or sensitivity of the transducer (converter) – and that's important for producing highly detailed images, Yakovlev says.

source: Eurekalert

Signostics Reveals New Ultrasound Device

Physicians now have access to an even faster and more accurate handheld ultrasound device, with Signostics today unveiling its new “Signos RT” model.

The Signos RT is Signostics’ second generation portable handheld ultrasound device and builds on the cutting-edge technology of the original Signos device by giving users the critical ability to view ultrasound images in real time.

Signostics anticipates the Signos RT will attract widespread interest from medical practitioners, healthcare professionals and veterinarians globally. The product is already available for sale in Australia and Europe, with USA availability for the human market pending 510(k) clearance.

Signostics Chairman Raymond Spencer says development of the Signos RT was made possible by a $1.9 million Early State Commercialisation grant from Commercialisation Australia (awarded in August 2011), which has helped position the company to capture a larger slice of the growing personal ultrasound market currently estimated to be worth around $3 billion globally.

source: Signostics

Ultrasound Reveals Autism Risk at Birth, Study Finds

Low-birth-weight babies with a particular brain abnormality are at greater risk for autism, according to a new study that could provide doctors a signpost for early detection of the still poorly understood disorder.

Led by Michigan State University, the study found that low-birth-weight newborns were seven times more likely to be diagnosed with autism later in life if an ultrasound taken just after birth showed they had enlarged ventricles, cavities in the brain that store spinal fluid. The results appear in the Journal of Pediatrics.

source: Science Daily (release)

VentriPoint Announces 3D Ultrasound Heart Analysis System and Prepares for Clinical Release

SEATTLE, WASHINGTON, Feb 21, 2013 (MARKETWIRE via COMTEX) -- VentriPoint Diagnostics CA:VPT +10.00% (otcqx:VPTDF) is pleased to announce the completion of a software package for 3D Echocardiography (3DE) - the newest addition to the software capabilities of its knowledge-based-reconstruction (KBR) family of VMS(TM) heart analysis systems. The VMS-3DE(TM) product works with all existing KBR databases and so can be applied to Tetralogy of Fallot (TOF), dextro-Transposition of the Great Arteries (d-TGA), Pulmonary Arterial Hypertension (PAH) and most right ventricles (NRV) without congenital heart disease or PAH including normal hearts.

"The VMS-3DE(TM) heart analysis system addresses a direct need in the ultrasound community by providing fast and accurate analyses of 3D acquired images of the right ventricle, which, up until now, has presented a significant challenge," stated Dr. George Adams, CEO of VentriPoint. "3D echocardiographic imaging has continued to improve and for more and more patients (usually children) clinically-useful images can now be obtained. But there has been a void in available tools to accurately analyze the right ventricle. Our new product fills this void and positions Ventripoint as a leader in this emerging segment of the market".

Initial clinical evaluation of the VMS-3DE(TM) product was performed at the Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany.

source: Marketwire

Primal Pictures Launches 3D Anatomy for Musculoskeletal Ultrasound: Upper and Lower Limb

Primal Pictures has launched 3D Anatomy for MSK Ultrasound: Upper and Lower Limb, an online and DVD tool that helps medical practitioners interpret musculoskeletal (MSK) ultrasound images. Faculty in ultrasound and radiology technology programs also use the MSK Ultrasound series educate students on the use and interpretation of MSK ultrasounds. It is the latest learning tool from the publishers of the most complete and medically accurate 3D model of human anatomy.

Medical practitioners are increasingly using ultrasound imaging to help diagnose musculoskeletal problems. 3D Anatomy for MSK Ultrasound: Upper and Lower Limb allows physicians to compare scans with 3D cross sectional anatomy images of the all parts of the upper and lower limb. The images are supported by extensive clinical content on common conditions and treatment options.

"Marrying Primal’s 3D anatomy model with commonly performed MSK sonographic views is a great help to those in training, and also serves as a valuable reference for more experienced MSK sonographers."

source: PR Web

Aixplorer®, with its UltraFast™ Platform, Raises The Bar In Pediatric Imaging

Dr. Franchi-Abella, a recognized leader in pediatric liver imaging, (Bicêtre Hospital, Paris, France) shared her very positive impression of the Aixplorer® ultrasound system for pediatric imaging.

AIX EN PROVENCE, France--(BUSINESS WIRE)--Dr. Franchi-Abella presented her pediatric liver scanning experience with the Aixplorer at a meeting during the Radiological Society of North America in November 2012.

At the Bicêtre Hospital, the leading French center for liver transplantation in children, Aixplorer’s real-time ShearWave Elastography imaging is used to non-invasively assess liver stiffness. These results are then compared and confirmed with fibrosis staging obtained from biopsy.

In her presentation, Dr. Franchi-Abella underlined the importance of ShearWave Elastography to help physicians in the characterization of the early stages of fibrosis with children. These early stages are often very difficult to detect. She also highlighted the benefits of Aixplorer to monitor evolving liver injuries, including cases of biliary atresia.

“Our experience with the detection and assessment of liver fibrosis for children with ShearWave Elastography is encouraging,” said Dr. Franchi-Abella. “This advanced technology could help to optimize the indications for a biopsy and to monitor spontaneous disease or treatment.”

source: Business Wire

Oregon Institute of Technology Installs 16 Toshiba Ultrasound Systems

To train students with the most advanced ultrasound technology available, Oregon Institute of Technology (Oregon Tech) installed 16 Aplio(TM) 300 ultrasound systems from Toshiba America Medical Systems, Inc. Oregon Tech will use the Aplio 300s to teach students in three medical imaging undergraduate programs.

"Oregon Tech offers a robust curriculum with more than 150 students imaging daily, so we needed reliable ultrasound equipment with no downtime and a partner offering exceptional service support," said LeAnn Maupin, professor of vascular technology and chair of medical imaging technology, Oregon Tech. "Toshiba's Aplio 300 gives Oregon Tech a competitive edge by offering students the most advanced technology with high quality images. The systems are ideal for an educational setting because they're easy to use with the ability to customize protocols for a variety of curriculums."

In addition, Oregon Tech utilizes other Toshiba ultrasound systems, including three Xario(TM) XGs, one Aplio Artida(TM) and five Aplio XGs.

source: Oregon Institute of Technology

Ultrasound breast cancer imaging device created at the Karmanos Cancer Institute one step closer to FDA approval

DETROIT, Jan. 28, 2013 /PRNewswire via COMTEX/ -- SoftVue, the whole breast ultrasound imaging device created by two scientists from the Barbara Ann Karmanos Cancer Institute and Wayne State University School of Medicine, is currently undergoing review by the U.S. Food and Drug Administration (FDA) for market clearance. It's anticipated that this first application clearance could come this spring, with several other FDA submissions to follow over the next couple of years. This promising imaging tool has the potential to aid in detecting breast cancer earlier, especially in women with dense breasts.

Peter Littrup, M.D., and Neb Duric, Ph.D., of the Karmanos Cancer Institute and Wayne State University School of Medicine, and their team have been working to perfect the SoftVue technology for more than a decade. The Karmanos Cancer Institute spun off a company in 2009 called Delphinus Medical Technologies to help secure funding to bring this device closer to commercialization. Since then, Delphinus has grown to 19 employees, many of whom are engineers, and plans are underway to gradually increase the sales staff once the first FDA market clearance is obtained.

source: MarketWatch

2013: Year of Ultrasound Declaration

Newswise — 2013: Year of Ultrasound (2013YOU) is a campaign designed to promote the widespread integration of ultrasound throughout the entire spectrum of medical school, allied health, and postgraduate medical education. This campaign is organized by the Society of Ultrasound in Medical Education (SUSME) and the American Institute of Ultrasound in Medicine (AIUM).

Individuals are encouraged to educate colleagues, inspire students, and share their knowledge of ultrasound throughout the year. Ways to support this mission include activities such as mentor a colleague; encourage the addition of ultrasound into a medical school’s curriculum; publish an article focusing on the use of ultrasound to solve a particular problem; encourage sessions dedicated to ultrasound at specialty society meetings; and post stories about the benefits of using ultrasound in the patient exam or screening.

source: Newswire

AIUM and AUA Guideline Development Leads To Practice Accreditation For Urologic Ultrasound

LAUREL, MARYLAND - The American Institute of Ultrasound in Medicine (AIUM) and American Urological Association (AUA) are proud to announce the collaborative development of practice and training guidelines in the practice of urologic ultrasound which has led to the availability of practice accreditation through the AIUM.

The Practice Guideline for the Performance of an Ultrasound Examination in the Practice of Urology has been developed to assist practitioners performing an ultrasound examination in the practice of urology and provides direction in the areas of kidney, bladder, prostate, scrotal and penile ultrasound. The guideline also addresses key issues relating to documentation, quality control and improvement, safety, infection control and patient education.

Another key resource is the recently developed Training Guidelines for the Performance of Ultrasound Examinations in the Practice of Urology. These guidelines both served as a roadmap for the development of practice accreditation for urologic ultrasound through the AIUM.

AIUM Ultrasound Practice Accreditation is a voluntary peer-review process that measures practices against nationally accepted protocols in training, practice, and safety. Practices that achieve accreditation show that they meet or exceed these standards. It is anticipated that practices accredited in urologic ultrasound will be more likely to receive payment for related ultrasound procedures. Applications for urologic ultrasound practice accreditation are accepted online at www.aium.org.

source: American Institute of Ultrasound in Medicine

Automated Breast Ultrasound Dramatically Reduces Physician Interpretation Time

Automated breast ultrasound takes an average three minutes of physician time, allowing for quick and more complete breast cancer screening of asymptomatic women with dense breast tissue, a new study shows.

Mammography misses more than one-third of cancers in women with dense breasts, said Rachel Brem, MD, lead author of the study. “Ultrasound can and does detect additional, clinically significant, invasive, node negative breast cancers, that are not seen on mammography, but a hand-held ultrasound screening exam requires 20-30 minutes of physician time. Having a technique that takes just three minutes is a “game-changer” in appropriately screening these women, said Dr. Brem.

The study, conducted at George Washington University Medical School in Washington, DC, quantitatively assessed the time it took for radiologists to interpret automated breast ultrasound examinations. The mean reading time for the three radiologists in the study was 173.4 seconds, said Dr. Brem.

Currently automated breast ultrasound is limited in use, although a Food and Drug Administration panel just recently voted in favor of its efficacy and safety. “When automated breast ultrasound is integrated in the screening environment, we will see the detection of smaller, more curable breast cancers. The days of one size fits all approach to breast screening are passing. Automated breast ultrasound provides us with a tailored approach based on the individual woman’s breast density,” Dr. Brem said.

source: ARRS

U-Systems Receives FDA PMA Approvable Letter for somo*v Automated Breast Ultrasound (ABUS) System

SUNNYVALE, Calif., May 14, 2012 (BUSINESS WIRE) -- U-Systems, the leader in automated breast ultrasound, announced today it has received a PMA approvable letter from the U.S. Food and Drug Administration's (FDA) for the company's somo*v(R) Automated Breast Ultrasound (ABUS) system. The somo*v ABUS system is the first ultrasound device to receive an approval recommendation from a FDA Advisory Panel and an approvable letter for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.

"The breast imaging community has known for some time that mammography does not work equally well in everyone, particularly the 40% of women in the United States who have dense breast tissue," said Ron Ho, President and CEO of U-Systems. "We are very excited to receive a PMA approvable letter for a breast cancer screening indication for the somo*v ABUS system, and to be one step closer to offering radiologists an important adjunctive screening tool which has the potential to find some 30 percent additional cancers that would not have been found with mammography. We are pleased that our development efforts, now supported by the FDA's scientific review of our safety and clinical data, are bringing us close to final PMA approval. With this response from the FDA, we will begin preparing for the launch of the somo*v ABUS system across the U.S."

source: Market Wire

GE's New Vivid E9 Cardiac Ultrasound System with 4D TEE Porobe receives FDA Clearance

GE Healthcare has announced today the FDA clearance and availability of the latest version of its Vivid E9™cardiovascular ultrasound system. The Vivid E9 Breakthrough 2012 (BT12) includes a 4D transducer for transesophageal echocardiography (TEE), and also provides innovative tools designed to help improve workflow efficiency through simplified image acquisition, intuitive navigation and advanced yet easy to use quantification.

Whilst Vivid E9 is currently used most frequently in the echo lab, the availability of the 4D TEE transducer enables the system to be used more often in settings including the cath lab, and the operating room. The TEE transducer will allow clinicians to view precise images of the heart during assessment/diagnosis performed in the echo lab, and support invasive surgical procedures in the operating room, as well as image-guided procedures in the cath lab. With the TEE transducer, Vivid E9 can now be leveraged for procedures including mitral valve repair, transcatheter aortic valve repair (TAVR/TAVI), atrial septal defect (ASD) closures and patent foraman ovale (PFO) closures.

source: GE Healthcare

GE Healthcare Enhances Workflow in Echo Lab, OR and Cath Lab with Vivid E9 Cardiovascular Ultrasound, Now Including 4D TEE Transducer

Wauwatosa, WISCONSIN — April 25, 2012 — GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced the FDA clearance and availability of the latest version of its Vivid E9™ cardiovascular ultrasound system. The Vivid E9 Breakthrough 2012 (BT12) includes a 4D transducer for transesophageal echocardiography (TEE), and also provides innovative tools designed to help improve workflow efficiency through simplified image acquisition, intuitive navigation and advanced, yet easy to use quantification.

While Vivid E9 is currently used most frequently in the echo lab, the availability of the 4D TEE transducer enables the system to be used more often in settings including the cath lab, and the operating room. The TEE transducer will allow clinicians to view precise images of the heart during assessment/diagnosis performed in the echo lab, and to support invasive surgical procedures in the operating room, as well as image-guided procedures in the cath lab. With the TEE transducer, Vivid E9 can now be leveraged for procedures including mitral valve repair, transcatheter aortic valve repair (TAVR/TAVI), atrial septal defect (ASD) closures and patent foraman ovale (PFO) closures.

source: GE Healthcare

U.S. Marshals seize ultrasound gel product at a New Jersey company

U.S. Marshals, acting at the request of the Food and Drug Administration, have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained dangerous bacteria. The seizure included all lots of the gel product manufactured between June 2011 and December 2011.

Until they were seized, the products were held under embargo by the New Jersey Department of Health and Senior Services at FDA’s request.

Under the Federal Food, Drug, and Cosmetic Act, the seized gel is adulterated, because product samples were contaminated with two strains of bacteria, Pseudomonas aeruginosa and Klebsiella oxytoca. The gel is also misbranded because it is dangerous to health when used in the manner suggested in the labeling. These bacteria pose serious risks of infection to individuals exposed to the product.

“This ultrasound gel presented serious health risks to patients, particularly vulnerable ones,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Therefore, FDA, with the assistance of our state partner, is taking aggressive enforcement action to protect the public health.”

According to the complaint filed in the U.S. District Court for the District of New Jersey, FDA analysis of product samples collected in February 2012 revealed the presence of the two bacterial strains.

The FDA received a report involving 16 surgical patients infected with Pseudomonas aeruginosa. The patients had transesophageal ultrasound procedures, while undergoing heart valve replacement, using Other-Sonic Generic Ultrasound Transmission Gel.

source: FDA News Release