The A/C Diagnostics unit of AntiCancer (San Diego) reported receiving FDA clearance for its A/C Portable Enzymatic Homocysteine Assay on the A/C Diagnostic Reader, using a genetically-engineered enzyme specific for homocysteine. The assay can measure total homocysteine (tHCY) in a three-step, single-enzyme procedure, with the A/C Diagnostics Reader, a small, portable fluorescence reader, and can assist diagnosis and treatment of hyperhomocysteinemia, a risk factor for cardiovascular disease and other diseases. This test is can be carried out in a small lab, a doctor's office or a pharmacy as it requires small amounts of blood, even from a finger prick, AntiCancer said. The assay kit is only for in vitro use.

• Avie Products (Austin, Texas) reported the introduction of a new product in the fight against breast cancer called "Cue." The waterproof electronic device, which reminds women, in the privacy of their showers, to perform regular breast self-exams, is being fully launched in the U.S. this month to coincide with National Breast Cancer Awareness Month. Cue tells the user, through a lighted display screen, to perform her breast self-exam seven days after her period begins. Cue works by asking the user a series of questions on a display screen, and then using the answers to determine when breast self-exam reminders should be displayed.

• Cepheid (Sunnyvale, California) said that the FDA has categorized its Xpert MRSA/SA Skin and Soft Tissue Infection (SSTI) test as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments. The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in SSTIs. Xpert MRSA/SA SSTI runs on Cepheid's GeneXpert system, the leading platform for on-demand detection of Healthcare Acquired Infections. The GeneXpert is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination.

• GE Healthcare (Chalfont St. Giles, UK) reported the release of Discovery positron emission tomography/computed tomography 600, GE Healthcare's newest PET/CT system at the annual meeting of the European Association of Nuclear Medicine. GE says the Discovery PET/CT 600 includes a scintillator with the highest sensitivity in the industry. GE BGO technology allows for improved lesion detectability, potentially reducing the dose requirement and allowing for faster scans and increased throughput. The Discovery PET/CT 600 provides a 70 cm bore offering a full 70 cm PET and CT field of view and a 500-pound patient table capacity. Discovery PET/CT 600 features a vertical scan range that provides more flexibility in radiation treatment planning and patient positioning, according to the company.

• iCAD (Nashua, New Hampshire) reported introduction of two MRI products. The SpectraLook is a kinetics technology integrated into iCAD's image analysis solutions for breast and prostate MRI studies; and CADvue is an image review and analysis software designed to improve the analysis workflow, interventional planning and reporting of breast MR results. SpectraLook, iCAD's breast MR analysis solution, provides more diagnostic information by creating colorized images based on signal changes defined by tumor physiology. CADvue image review and analysis software provides maximum functionality facilitating the analysis of ATP colorized images and quantitative data. CADvue allows the user to create standard and customized reports that enable the user to communicate time-sensitive breast MR study results to referring physicians.

• Smart Disc (Allen Park, Michigan) reported that it has conducted a cadaver test using its artificial spinal disc technology and that the test was deemed a success by the surgeons involved. The Smart Disc prosthesis is intended to maintain the normal movement between the vertebral bodies and prevent them from collapsing and thereby irritating or damaging the nerve root by maintaining the disc space height between the bones.

• Tomophase (Burlington, Massachusetts) said that it will display what it said is the first in vivo cross-sectional images of implanted pulmonary stents using their proprietary optical coherence tomography (OCT) system at the CHEST meeting in Philadelphia. The Tomophase OCT system enables the interventional pulmonologist to visualize sub-epithelial tissue structures in the airway. The system uses a near-infrared emitting probe in a catheter which is integrated with a conventional video bronchoscope. The images captured are from in vivo animal model tracheal tissue. During the next several months, the company plans to continue this work as it progresses towards use of the system in human clinical studies.

• Vision-Sciences (Berlin) reported the international introduction of its new video bronchoscopy platform at the 18th annual conference of the European Respiratory Society (ERS) in Berlin. The bronchoscopy system is the latest addition to Vision-Sciences' 5000 Series video endoscopy line. The new Vision Sciences BRS-5000 Flexible Bronchoscope is the first pulmonary endoscope in the company's new series of uniquely advanced digital endoscopy platforms. The lightweight videoscope design facilitates diagnostic as well as therapeutic procedures using a diameter insertion tube which contains a high-resolution, tiny charge-coupled device-based camera at the tip, offering a high-definition, full-screen image. The company has received FDA clearance and the CE mark to market the bronchoscopy system in Europe, Australia and other parts of the world.