• BD Diagnostics (San Diego), a segment of BD, reported that it has made a 510(k) submission to the FDA, for additional claims for the BD GeneOhm Staph assay. This will be the first assay for rapid and simultaneous identification of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from patients colonized in the nasal passage. The BD GeneOhm Staph assay is a test that provides results within two hours directly from nasal swabs. The company said the assay is easy to perform and requires less technologist time than traditional microbiology algorithms, which can take two days to generate results. Identifying patients colonized with MRSA or SA bacteria in advance of surgery helps ensure patients have an opportunity to be decolonized and receive the appropriate prophylactic antibiotics prior to surgery. This reduces the risk of a potentially deadly surgical site infection. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines.

• Firstlight Networks (Tustin, California) reported the introduction the Lumen imaging system with UL 60601-1 compliance. This technology is designed to allow users to convert that modality into a digital capture device in order to collect patient image files for further diagnosis or archival purposes. The Lumen imaging system provides hospitals, surgical centers, and medical practices with the ability to extend the functionality of their existing medical equipment by transforming them into digital capture devices. Firstlight provides specialized solutions for the medical and IT marketplaces.

• FlowCardia (Sunnyvale, California) reported the completion of enrollment into the Peripheral Approach To Recanalization In Occluded Totals (PATRIOT) study. The study was designed to assess the safety and efficacy of the peripheral line of Crosser catheters in lower limb chronic total occlusions (CTOs). The Crosser is a rapid exchange catheter delivered over standard .014” and .018” guidewires to the site of a CTO. Using high frequency vibration, the Crosser is designed to safely and quickly cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. FlowCardia is a privately held medical device company that makes CTO recanalization systems.

• Rochester Medical (Stewartville, Minnesota) reported the publication of results from a clinical study which demonstrates the effectiveness of the company’s proprietary infection control technology. The study, presented in the Annals of Internal Medicine concluded nitrofurazone-impregnated urinary catheters reduced the incidence of catheter-associated bacteriuria and funguria in adult trauma patients, reducing the need to change or prescribe new antimicrobial therapy. The nitrofurazone-impregnated urinary catheters used in the study were manufactured by the company. Rochester makes disposable medical catheters and devices for urological and continence care applications.

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