Roche Diagnostics announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the cobas® 8000 modular analyzer series, a Serum Work Area solution designed for diagnostic laboratories with a workload of 3-15 million clinical chemistry / immunochemistry tests per year. The cobas 8000 series is the newest member of the Roche cobas modular platform family, which combines clinical chemistry and immunochemistry testing.

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Endologix, Inc. announced that it received CE Mark approval to market its expanded offering of Powerlink® stent graft products and PowerFit™ Aortic Extensions in the European Union. The Company expects to launch the products in a limited market release in Europe during the fourth quarter of 2010, followed by a full product launch in 2011. Endologix recently received U.S. Food and Drug Administration (FDA) approval for these new products and they are currently in a limited market release in the U.S., with a full market release in the U.S. planned for the fourth quarter of 2010.

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Echo Therapeutics, Inc. has announced the completion of a clinical study of Prelude. This clinical study was designed to evaluate the ability of Prelude to ablate the skin prior to the application of OTC 4% lidocaine cream for faster-acting local dermal anesthesia. As a result of the clinical trial, Echo now expects the submission of a 510(k) premarket notification to the United States Food and Drug Administration (FDA) in the near future.

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Radiometer America announced that Radiometer’s next-generation, cassette-based analyzer, the ABL90 FLEX, received 510(k) clearance from FDA. The ABL90 FLEX analyzer is the latest addition to the company’s blood gas line, offering speed and high-throughput in a compact instrument. The ABL90 FLEX delivers blood gas results in 35 seconds, a turnaround time (TAT) unmatched by other blood gas analyzers on the market. The analyzer also processes up to 44 samples per hour.

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Abbott 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.

Roche Molecular Systems Inc announced that the FDA has cleared its new LightCycler® MRSA Advanced Test for the detection of methicillin-resistant Staphylococcus aureus (MRSA) for clinical use in the United States. The LightCycler® MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with bacterial MRSA. The test is designed to aid in the prevention and control of MRSA infections in healthcare settings.

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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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.

BTNX Inc is launching a promotion campaign, offering its Rapid Response branded blood glucose meters free of charge to those end users who have purchased 100 Rapid Response strips. The Rapid Response blood glucose meter is FDA cleared & CLIA waived. It reads results within 7 seconds, needs only 0.7 microliter blood sample, supports alternate site testing, requires no-cleaning and indicates ketone warning. With the large LCD screen, palm-sized dimensions and one-key operation, the device is the most user-friendly blood glucose meter in the marketplace.