• Abbott (Abbott Park, Illinois) said the FDA has approved its UroVysion DNA probe assay for use as an aid in the initial diagnosis of bladder cancer in patients with hematuria (blood in urine) suspected of having bladder cancer. The company said that with this approval, UroVysion is the first gene-based test available for both diagnosis and monitoring of bladder cancer recurrence. The test is designed to detect genetic changes in bladder cells in urine specimens using fluorescence in situ hybridization, or FISH. “UroVysion is significantly more sensitive than conventional methods for the detection of bladder cancer,“ said Michael Sarosdy, MD, a urologic oncologist and lead investigator of the UroVysion study. “This new use should allow physicians to make an earlier diagnosis, with earlier treatment.“

• Abiomed (Danvers, Massachusetts) provided a clinical update for the AB5000 Circulatory Support System, launched in April 2004. It said outcomes have continued to improve as the system has gone into wider use. Abiomed's ventricular assist devices, the AB5000 and the BVS 5000, are the only devices approved for bridge-to-recovery treatment following AMI-cardiogenic shock. The systems also are used to support the heart and allow for potential recovery following other acute events. Key facts on AB5000 usage and outcomes, based on Abiomed's voluntary data registry, include: more than 70% of survivors have been able to go home with their own hearts, and recovery of kidney function has allowed some heart patients to avoid planned kidney transplants; and one in four patients have been transitioned from the BVS 5000 to the AB5000, without re-opening the chest, avoiding risks associated with additional surgery to change out to other devices.

• GE Healthcare (Waukesha, Wisconsin) has unveiled new cardiac imaging techniques developed with the world's first high-definition magnetic resonance (HDMR) system. The applications were launched at the Society for Cardiovascular Magnetic Resonance's annual scientific sessions in San Francisco. HDMR provides physicians with what GE characterized as “unprecedented image clarity“ of patients who are difficult to image due to movement. The GE imaging techniques introduced at the meeting include 1.5 Tesla Excite HD MR Echo Cardiac Imaging, real-time imaging of the heart with the resolution of MR at the speed of ultrasound, without the need for breath-holding or ECG gating. The company said its MR Echo produces high-definition cardiac images in real time of the sickest of patients, providing clinicians with the contrast detail of MR with the real-time speed and ease of use of echocardiography. Also introduced was Excite HD TRICKS (Time-Resolved Imaging of Contrast KineticS) angiographic imaging, with a new 32-element peripheral 1.5 Tesla vascular coil providing images of the lower leg and foot vessels with what GE called “unprecedented definition.“ The company said TRICKS accelerates the temporal resolution of 3-D dynamic imaging, with clinicians able to acquire 12 times the amount of data typically collected in a conventional MR angiography exam. The company also is showing its ReportCARD tool, which it said “significantly reduces review, analysis and cardiac MR reporting time.“ HDMR, available on GE Signa 1.5 Tesla and 3.0 Tesla MR systems, enables massively simultaneous imaging in multiple channels in increments of 16.

• Lifestream Technologies (Post Falls, Idaho), a supplier of cholesterol monitors, unveiled a concept product at a recent FDA hearing on an over-the-counter petition for a cholesterol-lowering drug. Lifestream has filed a patent application for its new product, which it said reduces the cost for devices used for both the pharmacy and home testing. The technology under development looks like a computer mouse and embodies Lifestream's optic module and strip holder, but uses a PC for the balance of the functionality. Lifestream said that, along with weighing the product's value in the marketplace, it is evaluating production, features and if and when the product will debut. The company developed and currently markets a line of cholesterol monitors to consumers and healthcare professionals that provide test results in three minutes.

• NDCHealth (Atlanta), a provider of healthcare technology and information solutions, introduced the latest release of NDCMedisoft, the company's physician practice management system designed for small office practices, during the company's annual value added reseller summit in Las Vegas. NDCMedisoft Version 10 includes an integrated collections module enhances collections processes by keeping practices informed of both insurance and patient past due balances, while providing a single focal point to facilitate the entire collection process. The release also features security options to address HIPAA security requirements that take effect in April. These options include audit logs, as well as user and database security protocols to help protect electronic health records from unauthorized access. The new release also offers optional features, such as patient file archiving, which enables authorized users to archive and restore patient files to the database.

• Viasys Healthcare (Conshohocken, Pennsylvania) said its MedSystems business unit recently received FDA clearance to market the Cortrak system, a device designed to aid in the placement of enteral feeding tubes. The Cortrak system consists of a computer monitor, a receiver unit and a specially designed transmitter stylet. As the feeding tube is advanced, the monitor provides a real time representation of the feeding tube's relative position within the alimentary canal. Clinical studies indicate a high rate of successful bedside placement of small-bowel feeding tubes on the first attempt.

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