• BloodCenter of Wisconsin's Diagnostic Laboratories (Milwaukee) said that it is the first laboratory in the U.S. to develop and offer a genetic test, known as "CEBPA Mutation Analysis," for inherited acute myeloid leukemia (AML). AML is the second most common form of leukemia. The link between inherited variants in the CEBPA gene and the familial form of acute myeloid leukemia (AML) was first described in the New England Journal of Medicine in 2004. This relationship has subsequently been confirmed in several published reports. Almost all patients found to have inherited CEBPA mutations have had leukemia. Therefore, germline CEBPA mutations appear to predict the development of leukemia in individuals who lack manifestations of the disease. BloodCenter offers a modified version of CEBPA Mutation Analysis for non-inherited (sporadic) AML. This test is performed on DNA from the leukemia cells, rather than normal blood cells as in the test for inherited leukemia. In 15 – 18% of cases of a type of sporadic AML called "AML with normal cytogenetics" (CN-AML), CEBPA mutations serve as a biomarker that is associated with relatively favorable outcomes. CN-AML accounts for about 50% of all AML. BloodCenter is also believed to be the first laboratory in the United States to offer CEBPA testing for CN-AML.

• Caldera Medical (Agoura Hills, California) reported that it has received FDA clearance and CE mark certification for the Ascend Pelvic Floor Repair System with Apical Support, a novel treatment for female pelvic organ prolapse. Ascend is the latest addition to the Caldera Medical family of products designed to treat female stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The company said that Ascend introduces several key differentiators to the market. Notably, it provides apical support from the anterior compartment through unique implant geometry utilizing CentraSoft mesh technology and a patented surgical method that is designed to both reduce invasiveness and enhance patient outcomes. For patients with both anterior and apical defects, Ascend offers the ability to treat both defects with one surgical implant, reducing the potential for complications.

• Canon U.S.A. (Lake Success, New York) reported the introduction of the CR-1 Mark II Digital Non-Mydriatic Retinal Camera. The CR-1 Mark II can achieve detailed, high-resolution diagnostic images of the retina and enables a 45-degree view angle to help the eyecare professional detect and monitor ocular conditions. The CR-1 Mark II comes with Retinal Image Control Software, facilitating comprehensive study management and image capture control at the operator's finger tips through a simple to use graphical interface. The PC-based software provides quick input and access to all information and images required to assist in diagnosis, and data can be saved to various external media. The DICOM (Digital Imaging and Communication in Medicine) Standard-compliant interface facilitates easy integration with select PACS and HIS network configurations.

• Hologic (Bedford, Massachusetts) received FDA clearance for its R2 DigitalNow HD software application. The software is intended to process digitized screen-film mammograms for comparison purposes. The software adapts each digitized film image to a selected contrast and tissue intensity that models a digital mammography system. It also embeds a series of look-up tables in the image that allow Integrated Healthcare Enterprise (IHE) mammography conformant workstations to draw out less evident regions of density within digitized films. Hologic makes diagnostics and imaging systems for women's healthcare.

• Royal Philips Electronics (Eindhoven, the Netherlands) has launched a new release of its portable ultrasound system, the Philips CX50 CompactXtreme, to address the needs of a wide range of applications including radiology, vascular, women's health, emergency medicine, regional anesthesia, and critical care. The CX50 uses features migrated from the Philips iE33 and iU22 premium cart-based systems. PureWave transducers have been clinically proven to improve image quality across the patient population, especially on technically-difficult patients. Already, millions of exams have benefited from PureWave technology.