July 29, 2011 — The U.S. Food and Drug Administration (FDA) this week issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.

July 27, 2011 – A special panel convened July 21 in Gaithersburg, Md., to review the results of the Excor pediatric ventricular assist device (VAD) investigational device exemption (IDE) clinical trial. The panel convened at the request of Bram Zuckerman, M.D., director, division of cardiovascular devices, Center for Devices and Radiologic Health of the U.S. Food and Drug Administration (FDA).

July 27, 2011 – A new echocardiography remote reading program was introduced to provide expert exam interpretation in all 50 states. The new program, created by USARAD.com, a Joint Commission accredited provider of imaging services, is intended to address the longstanding need for fast, reliable interpretation of echocardiograms for mobile ultrasound companies and other imaging facilities across the nation.

July 27, 2011 – As the number of interventional procedures to diagnose and treat patients increases worldwide, and the procedures grow in complexity and length, exposure to radiation is a growing concern for both clinicians and patients. Interventional fluoroscopy is the third largest source of radiation from medical procedures, accounting for about 7 percent of the total radiation exposure of Americans in a year, according to a study by the National Council on Radiation Protection. GE’s Innova imaging systems help clinicians reduce radiation exposure without compromising the image quality they need to make confident decisions during interventional procedures.

July 26, 2011 – According to the 2011 Top 20 Best in KLAS Awards: Medical Equipment & Infrastructure report, GE Healthcare’s Logiq E9 has been recognized as the top general imaging ultrasound system in the market. In the same report, GE’s Vivid E9 was awarded a share of the top spot for cardiovascular ultrasound systems.