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.

November 18, 2008 - NEC Display Solutions Europe GmbH has chosen and will be shipping Matrox Xenia Series display controller boards for use with a variety of color and grayscale medical LCD displays, including next generation high brightness color medical displays.

November 18, 2008 - Ascent Healthcare Solutions, said yesterday it received the industry's first 510(k) clearance from the FDA to reprocess the LASSO 2515 Variable Circular Mapping Catheter manufactured by Biosense Webster.

With this new clearance, Ascent continues to increase its portfolio of EP catheters to offer EP cath labs the ability to most effectively manage their resources while ensuring that clinicians have access to their preferred device to most effectively diagnose arrhythmias, the company said.

November 18, 2008 - Stereotaxis Inc. this week launched its partnered magnetic irrigated catheter at centers in Europe, after its strong performance in the partner's recently concluded external evaluation.

November 18, 2008 - Cholesterol crystals released in the bloodstream during a cardiac attack or stroke can damage artery linings much further away from the site of the attack, leaving survivors at greater risk than previously thought, say researchers from Michigan State University.

November 18, 2008 - According to a study published in the Nov. 18 issue of the journal Circulation, Medtronic's Lead Integrity Alert (LIA) significantly improves early identification of potential implantable cardioverter-defibrillator (ICD) lead fractures.

November 17, 2008 - Medtronic received European CE Mark for the EnRhythm MRI SureScan Pacemaker System, a pacemaker designed for safe use in Magnetic Resonance Imaging (MRI) systems.

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