• Global Medical Research (Orlando, Florida), which said it is developing intellectual property that addresses problems in the biomedical field, reported the launch of technology designed to prevent post surgical adhesions. Its Internal-Tissue Engineered Membrane Product (i-TEMP) is poised for advanced phase animal testing to support the expectations of a broad spectrum of uses. The company said the i-TEMP's efficacy in prevention of adhesions is greater than 90%, and the product is easy to handle, can be delivered laproscopically, and is completely bio-absorbed after application.

• Siemens Medical Solutions (Malvern, Pennsylvania) has received FDA 510(k) clearance for MammoReport(Plus), a mammography softcopy reporting workstation that Siemens is showcasing at this week's National Consortium of Breast Centers conference in Las Vegas. The clearance allows for the processing of digital computer-aided (CAD) images and mammograms from approved vendors, expanded indications for multimodality viewing, and use with FDA-cleared monitors for the interpretation of lossless compressed images. In addition, MammoReport(Plus) is now Windows-based, which enables it to run on syngo, the intuitive software platform from Siemens that delivers powerful networking and post-processing capabilities. MammoReport(Plus) works in conjunction with Siemens' Mammomat Novation(DR) to provide a comprehensive system solution for clinical processes in mammography.

• SmartPill Diagnostics (Buffalo, New York), developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures biomedical data from within the patient's GI tract, reported that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are now underway at Massachusetts General Hospital (Boston). A total of 130 subjects and five clinical trial sites are expected to participate in 510(k) clinical trials of the SmartPill ACT-I Capsule and SmartPill GI Monitoring System. Of the 130 subjects, 70 are control and 60 are gastroparetic. Gastroparesis is one of the primary GI motility disorders in which the SmartPill ACT-I Capsule will aid diagnosis and management. Temple University Hospital (Philadelphia) will begin clinical trials next week, and three other sites will begin clinical trials shortly thereafter. The 510(k) clinical trials will be completed in May and will lead to 510(k) submission in June.

• St. Jude Medical (St. Paul, Minnesota) last week reported enrollment of the first patients in the ASSERT (ASymptomatic AF and Stroke Evaluation in Pacemaker Patients and the AF Reduction Atrial Pacing Trial) clinical study. The study will follow 2,500 patients for 3 1/2 years to determine if pacemaker-detected AHRE (Atrial High Rate Events) predict an increased risk of stroke in elderly hypertensive patients without previous atrial fibrillation (AF). ASSERT also examines the efficacy of St. Jude Medical's AF Suppression algorithm in helping these patients avoid symptomatic AF. Sinan Gursoy, MD, enrolled the first U.S. patient in the ASSERT study at Naples Community Hospital (Naples, Florida) and Seong-Wook Han, MD, enrolled the first Asian patient at the Keimyung University Dongsan Medical Center (Daegu, South Korea). The study is being conducted at 125 international clinical centers and coordinated by the Population Health Institute at McMaster University (Hamilton, Ontario). Patients enrolled in the study must be over 65, have a history of hypertension requiring drug therapy, and be recently implanted with a St. Jude Medical Identity ADx DR pacemaker with the AF Suppression algorithm.