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