November 20, 2008 - TeraRecon Inc. released new innovations in the cardiovascular and vascular clinical applications for its Aquarius iNtuition advanced visualization solution at the VEITH symposium Nov. 19-23, in New York City.

November 20, 2008 - FiatLux Imaging and Philips FIMI plan to demonstrate at RSNA 2008 the benefits of 3D imaging at the point-of-care using FiatLux Visualize on the Philips CliniScape mobile clinical assistant (MCA).

Developed by Philips in cooperation with the Intel Digital Health Group, the MCA meets the growing demand for clinical data access at the patient bedside and throughout the hospital.

November 20, 2008 - Lumen Biomedical Inc. said today the FDA cleared its FiberNet Embolic Protection System (EPS) for the treatment of patients receiving endovascular intervention for carotid artery disease.

The approval follows the recent release of the EPIC Clinical Study data demonstrating the lowest stroke rates of any filter currently available on the U.S. market, the manufacturer said.

November 20, 2008 - Patient Pamela Louderback was experiencing dizzy spells for months and arrived at St. Elizabeth Medical Center’s emergency room (ER) after blacking out one morning at work, and unbeknownst to her and her doctors, she was on the verge of suffering a stroke.

November 19, 2008 - Itamar Medical today announced a distribution agreement with EndoTech SPA to bring Itamar Medical’s patented Endo-PAT2000, a simple, office-based diagnostic test for the assessment of endothelial function, to the Italian market.

EndoTech SPA, based in Como, Italy, specializes in the distribution of medical instrumentation technologies in Italy. The partnership will allow Itamar Medical to reach new market and distribution goals for the Endo-PAT2000.

November 19, 2008 - Adding to its recent endovascular aortic repair (EVAR) innovations, Medtronic Inc. today launched its Talent Abdominal Stent Graft on the Xcelerant Hydro Delivery System in the U.S.

EVAR is a treatment for aortic aneurysm. In the U.S., abdominal aortic aneurysms – the most common type – are responsible for about 15,000 deaths annually. Worldwide, it is estimated that more than 1 million people are living with undiagnosed aortic aneurysms, and 95 percent of these could be successfully treated if detected before rupture.

November 19, 2008 - U.S. Reps. John Dingell (D-MI), chairman of the Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of the Subcommittee on Oversight and Investigations, yesterday launched an investigation into whether managers within the FDA Center for Devices and Radiological Health (CDRH) knowingly corrupted the scientific review process and approved or cleared medical device applications in violation of laws and regulations designed to assure the safety and effectiveness of medical devices.

With the full integration of GE Healthcare's (GE) Innova system with Volcano's s5i IVUS system, there is no need to roll around your IVUS unit. Through its collaboration with Volcano Corp., GE offers Innova IVUS as a fully integrated intravascular ultrasound system for the cath lab and interventional suite.

Volcano's IVUS automated features include: automatic border detection to identify lumen and vessel walls; automatic measurements to quantify lumen and vessel areas and diameters and plaque burder; and real-time VH IVUS to identify the type and amount of plaque present.

GE Healthcare's Innova 4100IQ is a large-format digital flat-panel X-ray system for angiographic imaging that incorporates GE’s exclusive Innova single piece, non-tiled digital detector (41cm-by-41 cm) to provide high-resolution imaging across the full range of vascular and interventional applications.

November 18, 2008 – The House Energy and Commerce Committee launched an investigation yesterday into allegations by at least eight FDA scientists that agency managers coerced those in the medical device division into approving products despite serious safety and effectiveness concerns.

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