• Perceptive Informatics (Boston), a subsidiary of Parexel International, reported the release of its Interactive Web Response System (IWRS) version 2.0. IWRS 2.0, a web interface for data capture, patient randomization and the management of study drug inventory for clinical trials, integrates with the company's Interactive Voice Response System. The system's interactive features include snapshots of project status as well as detailed study metrics. The Perceptive IWRS solution allows for seamless convergence between voice and web systems, and provides tools for site recruitment, management, inventory management and clinical supplies forecasting. The system can be configured for patient screening, enrollment, randomization, compliance and electronic patient-reported outcomes. The fully validated system is in compliance with 21CFR Part 11 regulations and guidelines.

• Signalife (Greenville, South Carolina), focused on the detection of cardiovascular disease through continuous ECG signal monitoring, reported that Duke University (Durham, North Carolina) has completed the Device Implementation, Validation and Application (DIVA) Program for the company's initial product, the Fidelity 100 Ambulatory EKG/ECG Monitor. A total of 108 patients, with clinical indications for elective or possible percutaneous coronary intervention, were recorded to provide detailed documentation of the device's ability to detect and quantify transient ischemic episodes in comparison to conventional ECG devices. Data is currently being analyzed by the eECG Core Laboratory at the Duke Clinical Research Institute.

• Sutura (Fountain Valley, California) said it has received 510(k) clearance from the FDA for use of the preloaded guidewire version of its patented SuperStitch vascular suturing device. The guidewire version of the SuperStitch allows physicians to re-access a vessel during procedures by placing the sutures first and completing suturing of the vessel after performing additional procedures if they choose. The guidewire version also enables physicians to use the SuperStitch GW on patients where they feel that maintaining access is more crucial. Sutura's line of SuperStitch devices provide sutured closure of the arteriotomy site utilizing the existing catheter sheath introducer or cannula during fluoroscopically guided procedures and directly through the open arteriotomy during open surgical procedures.

• Vidar Systems (Herndon, Virginia), a provider of medical film digitizers, reported the full release of Clinical Express 3.0 software for mammography. Used with the Vidar CAD Pro Advantage Film Digitizer, Clinical Express 3.0 allows prior film-based studies to be digitized and then reviewed alongside new studies on digital mammography workstations. The company said the CAD Pro Advantage delivers superior image quality, exceptional consistency and repeatability, and increased speed. The platform features Vidar's high-definition CCD technology and Automatic Digitizer Calibration. The CAD PRO Advantage also includes a film feeder designed for the highest reliability, productivity, and ease of use.

• VirtualScopics (Rochester, New York), a developer of image-related biomarkers, reported that it has been issued U.S. patent No. 6,984,981, “Magnetic Resonance Method and System Forming an Isotropic, High Resolution, Three Dimensional Diagnostic Image of a Subject from Two-Dimensional Image Data Scans,” by the U.S. Patent and Trademark Office. The patent relates to a new technology that improves upon the resolution and tissue contrast obtained from conventional MRI, providing more information from those images.

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