• AngelMed (Shrewsbury, New Jersey) reported the initiation of a Phase II pivotal U.S. trial for the AngelMed Guardian implantable cardiac monitor and alert system. The system is designed to reduce time to presentation by detecting significant changes in the heart's electrical signal and then alerting patients to seek medical attention. The system is comprised of an internal implantable device about the size of a standard pacemaker with a lead into the heart, an external telemetry device, and a programmer that aids physicians in evaluating heart signals.

• Avid Radiopharmaceuticals (Silver Spring, Maryland) reported that the FDA's Peripheral and CNS Advisory Committee provided strong support for development of amyloid imaging agents to test for the presence or absence of Alzheimer's disease pathology in people with symptoms of cognitive impairment. Avid said its Phase II amyloid imaging compound, 18F-AV-45 (AV-45), is well positioned to rapidly enter late-stage development based on the advisory committee recommendations. AV-45 was the first amyloid imaging compound to enter multi-center Phase II clinical studies in the U.S. and has now been studied in more than 250 people, ranging from cognitively normal individuals to those with Alzheimer's disease. Avid is currently conducting clinical trials at more than 25 research centers across the US and anticipates initiating Phase III trials early next year.

• CompuMed (Los Angeles) said it will preview its new CompuBridge telecardiology electronic medical records (EMR) solution at the National Conference on Correctional Health Care in Chicago. The CompuBridge EMR is designed to capture and integrate electrocardiogram (ECG) results and over-reads into an existing EMR system. Integration does not require the practice to employ additional software, hardware or specialized servers. CompuBridge EMR will provide users of CompuMed's telecardiology services with the ability to data mine patient records and electronically transfer those records to their own EMR systems, such as patient administrative systems, electronic practice management, laboratory information systems, dietary and pharmacy.

•Dune Medical Devices (Caesarea, Israel) reported the launch of a clinical trial of the MarginProbe intraoperative, real-time, positive margin detection system. The Dune MarginProbe system comprises a sterile hand-held probe and portable console. When the probe tip is applied to an excised lumpectomy segment, radio frequency signals are transmitted into the tissue and reflected back to the console, where they are analyzed using a specialized algorithm to determine tissue status. With streamlined operation and instantaneous results, the technology is designed for easy integration into existing surgical workflow.

The European Organization for Research and Treatment of Cancer (EORTC; Vedbaek, Denmark) has undertaken a multi-institutional prospective randomized clinical trial on 719 late-stage epithelial ovarian cancer patients. In this study, Oncotech (Tustin, California) EDR Assays were performed on biopsies obtained from 246 patients. Results clearly demonstrate that resistance to carboplatin, as identified by the Oncotech EDR Assay, was a significant independent predictor for response to first-line treatment in advanced ovarian cancer patients. The clinical trial results demonstrate that the use of the Oncotech EDR Assay predictive test can predict resistance to platinum-based chemotherapy before therapy is initiated. These results are important to ovarian cancer treating physicians, Oncotech said, since ovarian cancer is known to show resistance to platinum-based agents. Currently, the standard first-line treatment regimen for late-stage ovarian cancer contains platinum-based chemotherapy.

• Imaging Therapeutics (Redwood City, California) reported FDA clearance to market its OsDx hip bone mineral density (BMD) system. OsDx Hip BMD is a stand-alone X-ray image-processing software system intended to provide an estimate of BMD of the proximal femur using standard antero-posterior hip or pelvis radiographic images. This information may be used by physicians in the assessment of osteoporosis. Imaging Therapeutics' technology permits BMD testing to be performed using any conventional X-ray system because there are far more conventional systems than dual energy X-ray absorptiometers.