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

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

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

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

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

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

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

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

BK Medical Receives Coveted Frost & Sullivan Award in Surgical Ultrasound Market

PEABODY, Mass., Dec 29, 2011 (GlobeNewswire via COMTEX) -- BK Medical, part of Analogic's ultrasound group ALOG +1.74% , announced that it has received the 2011 Frost & Sullivan North American Product Differentiation Excellence of the Year Award in the Surgical Ultrasound Market. BK Medical recently highlighted this prominent award at the Radiological Society of North America (RSNA) 97th Scientific Assembly and Annual Meeting.

"Our noteworthy accomplishments in ultrasound reflect innovation and excellence in product engineering and design, which is evidenced by our comprehensive range of ultrasound systems, including Advanced Robotics Ultrasound Technology(TM) (ART(TM)), the industry's first complete imaging solution for robotic-assisted surgery that includes the Flex Focus(TM) 700 Ultrasound System," said Lars Shaw, Analogic's vice president of global marketing. "We are committed to providing our customers with the most advanced ultrasound imaging modalities, and we are truly honored to be recognized by Frost & Sullivan in the Product Differentiation Excellence category.

source: MarketWatch

SonoSite Begins International Shipments of New EDGE Ultrasound System

BOTHELL, Wash., Dec 21, 2011 (BUSINESS WIRE) -- SonoSite, Inc. SONO -0.15% , the world leader and specialist in hand-carried ultrasound for the point-of-care, announced it has received CE Marking (Conformite Europeenne) in the European Union to market its next generation point-of-care product: EDGE(TM) ultrasound system. The EDGE system is currently available for sale in the U.S., following receipt of FDA Premarket Notification 510(k) clearance in November. SonoSite is now commencing international customer deliveries.

Engineered with new state-of-the-art technology, the EDGE ultrasound system takes point-of- care ultrasound to a whole new level of clinical performance and enables physicians to deliver the highest standard of patient care by driving greater efficiencies and the potential for improved outcomes in the hospital and office.

The EDGE ultrasound was formally introduced this fall at medical meetings and congresses in Europe and Australia. Physicians positively responded to the system:

"As a faithful SonoSite user, I want the company's products to remain true to its core elements, namely user friendliness, simplicity of use and rapid acquisition of a great image," said Amit Pawa, MD, Anesthesiologist Consultant, Guy's and St. Thomas' NHS Foundation Trust, London, UK. "The EDGE system clearly accomplishes this while looking futuristic, sleek and sophisticated. Physicians will also benefit from the back-lit screen and wipe-able keypad. Overall, the image quality is superior and I can't wait to use it in clinical practice."

source: SonoSite

Fujifilm Holdings Announces Agreement to Acquire SonoSite, Inc.

TOKYO & BOTHELL, Wash., Dec 15, 2011 (BUSINESS WIRE) -- FUJIFILM Holdings Corporation (hereinafter:Fujifilm), a diversified technology company that operates in healthcare, highly functional materials, and document solutions, announced today that it has entered into a definitive agreement with SonoSite, Inc. SONO +0.00% (hereinafter:SonoSite), a pioneer and leader in bedside and point-of-care ultrasound technology, pursuant to which Fujifilm will acquire SonoSite for approximately $995 million (which includes amounts payable in connection with its convertible debt). The transaction was unanimously approved by the Boards of Directors of both companies.

Fujifilm, through a U.S. subsidiary, will make an all-cash tender offer to purchase all outstanding shares of SonoSite common stock for $54 per share in cash. The purchase price represents a premium of 50.0% over SonoSite's average closing stock price over the three months ended December 14, 2011, and a 75.4% premium over the closing price on November 2, 2011, the last trading day before news reports relating to a possible sale transaction were first published. The tender offer is scheduled to commence within 20 business days and will remain open for 21 U.S. business days.

source: MarketWatch

Zonaire Medical Systems to Showcase z.one Ultrasound Platform at RSNA

CHICAGO, November 28, 2011 - ZONARE Medical Systems, Inc., a developer of premium ultrasound solutions, will showcase the z.one system focused on abdominal ultrasound imaging solutions for diverse patient populations here shown at the 97th Annual Meeting of the Radiology Society of North America, November 27 – December 2.

ZONARE’s z.one ultrasound system delivers high-end image quality powered by its proprietary Zone Sonography™ Technology (ZSTTM) which compensates for speed of sound variations across patients enabling optimum image quality among a diverse patient population. The system delivers stellar performance and provides mobility and workflow advantages across a wide variety of radiology applications, ranging from neonatal to bariatric patients.

"In my experience, the highly mobile ZONARE system delivers premium pediatric imaging performance in practical applications. Using the C10-3, C9-3 and C6-2 transducers provides consistently uniform imaging at depth on neonates to teenagers with color Doppler performance comparable to our other premium systems," said Dr. Brian Coley, radiologist-in-chief at Cincinnati Children’s Hospital Medical Center.

source: Zonaire

Toshiba Launches Aplio 500 Ultrasound with Advanced Fly Thru and Smart Fusion Features

CHICAGO, Nov 27, 2011 (BUSINESS WIRE) -- Toshiba America Medical Systems, Inc., launched the Aplio(TM) 500 ultrasound system, enabling clinicians to diagnose like never before, using the most advanced visualization tools in the industry. The Aplio 500 ultrasound is 510(k) cleared and displayed at the Radiological Society of North America (RSNA) annual meeting in Chicago, Nov. 27 -- Dec. 2, 2011 (Booth #5634, South Hall).

Aplio 500 combines advanced visualization capabilities, workflow automation tools and superior ergonomics for more accurate diagnoses and improved departmental efficiency. The system is backed by Toshiba's Reliance Program, the industry's best warranty/technology protection program.

Toshiba's Aplio 500 comes optional with Fly Thru and Smart Fusion, two advanced features unmatched in the industry:

-- Fly Thru: This industry-first technology revolutionizes ultrasound diagnosis using 3D volume rendering to "fly through" interiors of ducts and vessels for better exploration of lesions and masses, and to assist in planning interventional procedures. Fly Thru gives clinicians an entirely new perspective of 3D imaging.

-- Smart Fusion: Shows both CT and ultrasound images side-by-side on a single screen. Smart Fusion syncs the two images, helping to locate hard-to-find lesions and aiding in ultrasound-guided biopsy without additional CT scans. Toshiba's Smart Fusion is easy to use, with the most intuitive user set-up available.

source: Market Watch

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