Sunday, July 1, 2012

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

Tuesday, June 19, 2012

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

Monday, May 14, 2012

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

Tuesday, May 1, 2012

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

Thursday, April 26, 2012

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

Monday, April 23, 2012

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

Saturday, April 14, 2012

FDA Panel Recommends Approval for U-Systems’ Breast Cancer Screening Tool for Women with Dense Breasts

GAITHERSBURG, Md., Apr 11, 2012 (BUSINESS WIRE) -- U-Systems, the leader in automated breast ultrasound, today announced that the U.S. Food and Drug Administration’s (FDA) Radiological Devices Panel of the Medical Devices Advisory Committee recommended approval of the somo*v® Automated Breast Ultrasound (ABUS) system. U-Systems’ premarket approval (PMA) application is seeking a breast cancer screening indication for the somo*v ABUS system, which is currently FDA-cleared for diagnostic use as an adjunct to mammography.

If final PMA approval is granted, the somo*v ABUS system would be the only ultrasound device in the United States approved for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue. Although the FDA is not bound by the recommendations of its advisory committees, it generally follows their advice.

“With the positive FDA panel review of the somo*v for breast cancer screening, we now have the opportunity to integrate 3D automated breast ultrasound screening into clinical practice, which will enable us to find previously undetectable cancers,” said Rachel Brem, M.D., Director of Breast Imaging at The George Washington University Hospital, Washington D.C. “Mammography is an effective tool at finding breast cancer, but it doesn’t work equally well in everyone. In women with dense breasts, we can’t see over a third of breast cancers, so we need other technologies, other approaches.

source: Market Watch

Wednesday, February 29, 2012

Proven Benefits of ShearWave(TM) Elastography: Radiology and European Radiology Journals Report High Reproducibility and Significant Improvement of Breast Ultrasound Specificity

AIX-EN-PROVENCE, France, Feb 29, 2012 (BUSINESS WIRE) -- The much anticipated results of the largest clinical breast study ever sponsored by an ultrasound manufacturer have recently been published in the prestigious peer reviewed Radiology and European Radiology medical journals. The multinational, multicenter "Breast Elastography 1 (BE1)" study, involving renowned clinicians in the breast radiology community, assessed the clinical benefits of ShearWave Elastography in the ultrasonic diagnosis of breast lesions.

The study had two objectives: The first was to demonstrate that images obtained using ShearWave Elastography were reproducible. The second was to compare ultrasound alone versus the combination of ultrasound and ShearWave Elastography for breast lesion characterization. The goal of the latter was to improve lesion classification in categories BI-RADS(R) 3 and BI-RADS(R) 4, where most treatment dilemmas occur, in order to better direct patients towards clinical short-term follow-up or biopsy.

source: Market Watch

Wednesday, February 1, 2012

MSK ultrasound volume increase higher among non-radiologists, study suggests

Between 2000 and 2009, the musculoskeletal (MSK) ultrasound volume increase among non-radiologists was much higher than that among radiologists, according to a study in the February issue of the Journal of the American College of Radiology. Ultrasound images of the MSK system provide pictures of muscles, tendons, ligaments, joints and soft tissue throughout the body.

Over the past two decades, MSK ultrasound has emerged as an effective means of diagnosing MSK pathologies. However, some insurance providers have expressed concern about increased MSK ultrasound utilization, possibly facilitated by the low cost and ready availability of ultrasound technology.

Data was obtained from the CMS Physician/Supplier Procedure Summary Master Files from 2000 to 2009, and records were extracted for procedures for extremity non-vascular ultrasound. Researchers analyzed annual volume by provider type using specialties, practice settings and geographic regions where the studies were performed.

Results showed that musculoskeletal ultrasound volume increased from 56,254 procedures in 2000 to 233,964 in 2009. However, the MSK ultrasound volume increase among non-radiologists, especially podiatrists, was far higher than that among radiologists from 2000 and 2009, with the highest growth in private offices.

source: EurekAlert

Tuesday, January 17, 2012

Ultrasound Guided Needle Aspiration versus Surgical Drainage in the management of breast Abscesses: A Ugandan experience

Despite breast abscess becoming less common in developed countries, it has remained one of the leading causes of morbidity in women in developing countries. A randomized controlled clinical trial was conducted at Mulago hospital complex in Kampala Uganda to establish whether ultrasound guided needle aspiration is a feasible alternative treatment option for breast abscesses.
Results

A total of 65 females with breast abscess were analyzed, of these 33 patients were randomized into the ultrasound guided needle aspiration and 32 patients in the Incision and drainage arm. The mean age was 23.12, most of them were lactating (66.2%), primipararous (44.6%) with peripheral abscesses (73.8%) located in the upper lateral quadrant (56%).The mean breast size was 3.49 cm. The two groups were comparably in demographic characteristic and breast abscess size. Survival analysis showed no difference in breast abscess healing rate between the two groups (Log rank 0.24 df 1 and P = 0.63). Incision and drainage was found to be more costly than ultrasound guided aspiration (cost effective ratio of 2.85).
Conclusion

Ultrasound guided needle aspiration is therefore a feasible and cost effective treatment option for both lactating and non lactating breast abscesses with a diameter up to 5 cm by ultrasound in an immune competent patiet,

source: BioMed Central (open access)

SonoCine Automated Whole Breast Cancer Screening System Receives Approval from Health Canada

RENO, Nev., Jan 17, 2012 (BUSINESS WIRE) -- SonoCine, Inc., the leading innovator of automated whole breast ultrasound (AWBU) screening systems for early detection of breast cancer, announced today that it has been granted a Class 2 Medical Device License by the Medical Devices Bureau of Health Canada to sell and market its Automated Whole Breast Acquisition Screening System (AWBASS) as an adjunct to mammography for screening asymptomatic women for breast cancer.

The SonoCine AWBASS is an accessory to already approved ultrasound scanners, providing computer controlled automatic acquisition and subsequent dynamic review of closely spaced consecutive 2D images of the entire breast and lower axilla. The integration of SonoCine AWBASS and a standard ultrasound scanner forms an Automated Whole Breast Ultrasound (AWBU) screening system.

The SonoCine system received FDA 510(k) clearance in the U.S. in 2008 as an adjunct to mammography, but not a replacement for screening mammography, and in 2010 the results of the first breast cancer screening trial were published in the peer reviewed medical journal, European Radiology.

source: SonoCine

Saturday, January 14, 2012

FDA Clears Siemens’ New ACUSON SC2000 Ultrasound System, Release 2.0

Malvern, Pa., January 11, 2012– Siemens Healthcare has announced that Release 2.0 of the ACUSON SC2000™ volume imaging ultrasound system has received 510(k) clearance from the Food and Drug Administration (FDA) and is now commercially available in the United States. This latest version of the ACUSON SC2000 system – Siemens’ pioneering premier echocardiography system – elevates volume imaging in echocardiography to a new level, delivering significant performance and imaging enhancements to improve workflow and patient outcomes. Release 2.0 offers a host of new applications, including the quantification of the 3D proximal isovelocity surface area (PISA) to assess the severity of valvular disease and volumetric color Doppler. Other applications include a comprehensive package for automated left ventricle analysis (LVA), which enables the auto-detection and tracking of volume contours, and Siemens’ exclusive IN Focus coherent image-forming technology, which yields a high level of image uniformity and clinical detail. Release 2.0 supports volumetric intracardiac echocardiography (ICE), enabling integration of the ACUSON AcuNav™ ultrasound catheters.

Through the advanced volume analysis application known as eSie PISA™ – an industry first from Siemens – the user of the ACUSON SC2000 system can obtain semi-automatic quantification of the PISA from 4D color Doppler data. This quantification enables the clinician to eliminate the current practice of 2D PISA assumptions and improve measurement accuracy by using volumetric color analysis for valvular regurgitation, which affects millions of people worldwide.

source: Siemens

Friday, January 13, 2012

Remote Lung Ultrasound through iPhone and Skype

Studies have indicated that at least two common life threatening conditons, Apnea (APN) and pneumothorax (PTX), can be reliably identified through use of ultrassound and an iphone. Both APN and PTX may be ruled out by visualizing respiratory motion at the visceral-parietal pleural interface known as lung sliding (LS), corroborated by either the M-mode or color-power Doppler depiction of LS.

In the study ultrasound images were obtained through a handheld unit and streamed through Skype to an iphone. Remote expert sonographers then directed remote providers to obtain images by viewing the transmitted ultrasound signal and consulting with the remote examiner over a head-mounted webcam. Examinations were conducted between a series of remote sites (among them a number of mountain locations and a small moving plane) and a fixed base station.

The results obtained demonstrated that in all lung fields on all occasions LS could easily and quickly ne identified.

NCBI abstract

Wednesday, January 11, 2012

Unisyn Now Repairing Logiq(R) E9 Ultrasound Transducers

GOLDEN, Colo., Jan 10, 2012 (BUSINESS WIRE) -- Unisyn Medical Technologies, Inc., a leading provider of sustainable solutions to the diagnostic imaging industry, today announced it has the capability to repair and test select Logiq(R) E9 ultrasound transducers manufactured by GE. Unisyn is the only probe repair company that offers proprietary FirstCall(TM) testing and verification capabilities on Logic E9 ultrasound transducers.

Rebecca Whitney, Unisyn's Chief Marketing Officer, commented, "We are excited to add this important new offering to our portfolio of high-quality probe repair and exchange. Our ability to provide proprietary FirstCall repair and testing capabilities on Logic E9 ultrasound transducers allows us to confidently diagnose, repair, and test these probes, which ensures that we deliver high-quality probe repair to our customers."

Unisyn provides Biomedical and Clinical Engineers with high quality and comprehensive ultrasound probe repair and exchange at an economic value.

source: MarketWatch

Tuesday, January 3, 2012

EAE/ASE 3D echocardiography image acquisition recommendations

Philadelphia, PA, January 3 – For the first time, a joint committee of the European Association for Echocardiography and the American Society of Echocardiography have issued recommendations on image acquisition using three-dimensional echocardiography (3DE). 'The EAE/ASE Recommendations for Image Acquisition and Display Using Three-Dimensional Echocardiography', are available in the January 2012 issue of the Journal of the American Society of Echocardiography (JASE), published by Elsevier.

The recommendations are a practical guide on how to acquire, analyze, and display the various cardiac structures using 3DE, and discuss the advantages and limitations of this technique. The document also describes current and potential clinical applications of 3DE and its specific strengths and weaknesses in each scenario. The same issue of JASE includes articles that explore novel applications of 3DE and illustrate the clinical relevance of this technique.

source: EurekAlert