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