Monday, October 31, 2011

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

Monday, October 24, 2011

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