• Corgenix Medical (Denver) has submitted a 510(k) premarket notification to the FDA for the company’s IgG Anti-AtherOx test kit. This new laboratory test uses the company’s AtherOx technology to detect IgG antibodies to complexes formed by oxidized low-density lipoprotein (oxLDL) with b2-glycoprotein I (b2GPI) in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). The AtherOx technology uses oxLDL complexed with the plasma protein b2GPI. Although oxLDL has been implicated in cardiovascular disease, clinical data demonstrates that the determination of oxLDL/b2GPI complexes (AtherOx), rather than oxLDL alone, is a more physiologic and accurate way of assessing the risk of progressive atherosclerotic cardiovascular disease. Corgenix licensed this technology in 2002, and is developing additional products utilizing this platform. Corgenix makes specialized diagnostic kits for vascular diseases, immunology disorders, and bone and joint disorders.

• Siemens Medical Solutions (Malvern, Pennsylvania) reported the release of a new version of syngo Colonography PEV (polyp enhanced viewing), an automated second reader tool for the visualization of lesions in the colon. The solution helps radiologists to detect polyp-shaped objects between 6 mm and 25 mm in size and can now be used both in clean-prepped and solid-liquid tagged protocols. With the new version, syngo Colonography PEV delivers the benefits of computer-assisted reading to a wider range of protocols commonly applied in CT colonography today, including stool tagging agents. The PEV tool is seamlessly integrated into the syngo Colonography CT application. Together with workflow-enhancing features such as auto polyp measurements, the software is designed to improve reading accuracy and efficiency. The solution was developed using a database of more than 1,700 CT colonography cases from more than 15 clinical sites worldwide, and covers a variety of CT acquisition parameters and bowel preparation protocols. Siemens Medical Solutions, a division of Siemens (Munich, Germany), provides medical technologies to the healthcare industry.