May 5, 2008 - The FDA has notified GE Healthcare's Surgery Business that the company has satisfied the criteria in the January 2007 consent decree required to resume operations, and can distribute the OEC 9900 Elite C-arm.

The 9900, a fluoroscopy device that uses X-rays to reveal real-time imagery of a patient's internal structure, is the first product to receive manufacturing and shipping authorization. More than 300 of these units will be shipped to customers in the first 10 days of operations.

After GE Healthcare implemented enhancements to the OEC 9900 Elite C-arm, a fluoroscopy device that uses x-rays to reveal real-time imagery of a patient's internal structure, it filed a new 510(k) for the unit.

The 9900 Elite C-arm, the company's flagship C-arm offers a fully-motorized option designed to give the user complete control of the C-arm's lateral and orbital movements at 9 degrees per second – right from the tableside control panel with an easy-to-use joystick. A collision protection system provides both audible and visual warnings when it detects contact.

May 1, 2008 - High-amplitude electrogram T-wave alternans often precedes spontaneous ventricular tachycardia (VT) and ventricular fibrillation (VF) in humans, and can be detected by measuring stored data directly from implantable cardioverter-defibrillators (ICDs), according to a new study published in the May issue of HeartRhythm, the official journal of the Heart Rhythm Society,

May 1, 2008 - Covidien has introduced the VascuSeal Vascular Sealant System throughout Europe and in select Middle East markets, offering surgeons a hydrogel that provides an immediate, blood-tight seal that is effective intraoperatively and throughout the critical healing period.

May 2, 2008 - The Centers for Medicare and Medicaid Services (CMS) has given Abiomed a positive National Coverage Determination (NCD) that allows coverage of the AbioCor Total Replacement Heart, marking the first positive coverage position CMS has taken since a non-coverage determination was issued for artificial hearts in 1986.

CMS Acting Administrator Kerry Weems stated, "Our decision revises a long-standing non-coverage policy and allows beneficiary access to this advanced technology."

Emageon's Enterprise Content Manager (ECM) is a single, enterprise-centric application that is said to easily integrate in an open-systems framework with departmental diagnostic applications such as radiology, cardiology and pathology PACS, and consolidates imaging information over its life cycle.

May 1, 2008 - Cardiothoracic surgeons will discuss the benefits of using new technologies to facilitate off-pump coronary artery bypass (OPCAB) procedures, including minimally invasive robotic-assisted surgery at the symposium "Innovations in Revascularization" hosted by Cardica, Intuitive Surgical, MAQUET Cardiovascular and Transonic Systems.

May 1, 2008 - The clinical impact of the first-ever prohealing stent, OrbusNeich's Genous Bio-engineered R stent, is the subject of a symposium at next month's 16th Annual Scientific Congress of the Hong Kong College of Cardiology.

Federico Piscione, M.D., of Federico II University, Naples, will present the latest clinical update on the Genous technology at the conference.

May 30, 2008 - St. Jude Medical Inc. launched the TigerWire Steerable Guidewire, designed to enhance physicians' ability to steer through challenging peripheral arteries, as the company extends its GuideRight portfolio of steerable guidewires.

The TigerWire Steerable Guidewire is a thin, flexible wire that physicians use to help guide and steer a catheter (a flexible tube) through the arteries. Catheters are used to assist in diagnosing and treating blockages caused by a build-up of plaque inside artery walls.

May 1, 2008 – Royal Philips Electronics and BrainLAB said they would be collaborating on the integration of intra-operative angiography and image-guided surgery (IGS).

The integration of angiography and IGS would provide surgeons with real-time information during interventions that may lead to more precise surgical procedures.

Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now