Abbott has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market a new, sensitive molecular diagnostic test and instrument to simultaneously detect two of the nation’s most prevalent sexually transmitted diseases (STDs), gonorrhea and chlamydia, including a new variant strain of chlamydia recently discovered in Sweden. Abbott received independent 510(k) clearances for both the Abbott RealTime Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) assay and the Abbott m2000 System.

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Cardiac Science Corporation has introduced the remaining versions of software required for the recall. The software will enhance the automated external defibrillator’s (AEDs) self-test capabilities and improve detection of a rare component-related issue in certain AEDs. The company announced a recall on these AEDs on November 13, 2009. The software update is a mandatory step for customers possessing these affected devices. Customers with affected AEDs will be notified by letter regarding the update.

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Riverain Medical® has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the newest version of the OnGuard™ Chest X-ray Computer-Aided Detection (CAD) technology. OnGuard identifies solitary pulmonary nodules that may represent early-stage lung cancer on an existing chest X-ray. This improved performance demonstrates a 73% reduction in false positive marks and 50% higher relative sensitivity compared to the original product.

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Epocal, Inc. has announced that it has received U.S. Food and Drug Administration (FDA) clearance to market its new lactate test on the epoc Blood Analysis System. Lactate measurements from the epoc System are used to evaluate acid-base status and for diagnosis and treatment of lactic acidosis. The addition of lactate to the epoc BGEM Test Card further expands the clinical utility of the Company’s point of care blood gas and electrolyte platform.

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Researchers from the Peninsula Medical School, working in collaboration with colleagues from Glasgow Royal Infirmary and the University of Brighton, have used a unique collection of pancreas specimens taken from patients who died soon after diagnosis of type 1 diabetes to show that they respond to the ongoing process of destruction by inducing their islet cells to proliferate. The research is published on-line at Diabetologia and is funded by Juvenile Diabetes Research Foundation.

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A study presented at SNM’s 57th Annual Meeting shows that using multiple imaging agents with a hybrid imaging technique can be a valuable tool for accurately diagnosing and determining treatment for various diabetes-associated foot diseases. A common complication from Type 2 diabetes is the decreased ability to heal from even the most minor infections. Due to reduced blood circulation and nerve damage associated with the disease, infections of the feet are a major concern.

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The Food and Drug Administration (FDA) has approved GE Healthcare’s hexaminolevulinate HCl (Cysview) technique. The technique can help in detecting the bladder’s non-muscle-invasive papillary cancer for patients with suspected or bladder cancer.

An international research consortium has identified four common gene variants that are associated with blood levels of vitamin D and with an increased risk of vitamin D deficiency. The report from the SUNLIGHT consortium – involving investigators from six countries – will appear in The Lancet and is receiving early online release. The SUNLIGHT Consortium involved a research team from the U.S., U.K., Canada, Netherlands, Sweden and Finland.

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