May 6, 2008 - Vascular Insights received 510(k) clearance from the FDA to market its ClariVein infusion catheter for infusion of physician-specified agents in the peripheral vasculature.

ClariVein is a percutaneous, 2 2/3 Fr (0.035-inch) catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area.

May 6, 2008 - Philips has introduced new disposable adult ECG leadwire electrodes designed to be easy to use and to provide patient monitoring products to assist in the prevention of cross-contamination.

May 6, 2008 - Philips' IntelliVue mobile viewer application gives physicians access to patient information from anywhere within the hospital by providing patient data and alerts through a personal digital assistant (PDA) device.

May 5, 2008 - HeartWare Ltd. received conditional approval from the FDA of an Investigational Device Exemption (IDE) for its lead product, the HeartWare Left Ventricular Assist System (LVAS), enabling the company to commence its U.S. clinical trial for the HeartWare LVAS for use as a bridge to cardiac transplant in patients suffering from end-stage heart failure.

May 1, 2008 - Doctors performed the first ever bi-directional live case transmission and training course recently conducted via the Stereotaxis Odyssey Network, a system designed to fully integrate all of the systems in a typical EP lab around our information management platform, and to connect lab-to-lab within and between hospitals.

May 6, 2008 - Cordis Corp.'s U.S. launch of the SLEEK and SAVVY Long PTA Balloon Dilatation Catheters represents the company's most advanced percutaneous transluminal angioplasty (PTA) balloon catheters.

"These products incorporate our most advanced balloon technology and underscore our commitment to providing physicians with a full range of treatment options for patients with peripheral vascular disease," said Todd M. Pope.

Vascular Insights' recently 510(k) cleared ClariVein infusion catheter is designed for infusion of physician-specified agents in the peripheral vasculature.

ClariVein is a percutaneous, 2 2/3 Fr (0.035-inch) catheter, containing a rotating wire driven by a motor, that enhances fluid dispersion in the treatment area.

May 6, 2008 - Philips' IntelliVue mobile viewer application gives physicians access to patient information from anywhere within the hospital by providing patient data and alerts through a personal digital assistant (PDA) device.

May 6, 2008 - Cordis Corp. U.S. launch of the SLEEK and SAVVY Long PTA Balloon Dilatation Catheters, representing the company's most advanced percutaneous transluminal angioplasty (PTA) balloon catheters.

"These products incorporate our most advanced balloon technology and underscore our commitment to providing physicians with a full range of treatment options for patients with peripheral vascular disease," said Todd M. Pope.

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.
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