Diagnostics Product Guide » FDA Approval

Roche Receives FDA Clearance For U.S. Launch Of Cobas 8000 Modular Analyzer Series For High-Volume Laboratory Testing

admin — Tue, 14 Sep 2010 15:03:32 +0000

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 Receives CE Mark Approval For Expanded Line Of Powerlink Products And PowerFit Aortic Extensions

admin — Wed, 01 Sep 2010 09:00:41 +0000

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 Announces Successful Completion Of Clinical Trial For Prelude(TM) SkinPrep System And 4 percent Lidocaine Cream

admin — Thu, 26 Aug 2010 13:51:34 +0000

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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New ABL90 FLEX POC Analyzer by Radiometer Receives 510(k) Clearance

admin — Thu, 26 Aug 2010 13:47:43 +0000

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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ViKY(R) Robotic System Enters The Operating Room In Korea

admin — Thu, 19 Aug 2010 08:40:11 +0000

EndoControl and ASC Korea have got KFDA (Korean Food and Drug Administration) approval for the ViKY® robot. After the success of ViKY® Endoscope Positioner in Europe and the US, EndoControl decided to open the Asian market by entering Korea, Taiwan and India for the first step. ViKY® is a very simple compact robot which takes up no floor space. The robot is voice or foot controlled by the surgeon for more comfort and accuracy.

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Abbott Receives 510(k) Clearance For CT/NG Assay And Abbott m2000 System

admin — Thu, 08 Jul 2010 21:01:55 +0000

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 Gets FDA Ok For LightCycle Test

admin — Thu, 08 Jul 2010 20:57:24 +0000

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.

Abbott Gets FDA Clearance For Molecular Diagnostic Test For Detection Of Chlamydia And Gonorrhea Infections

admin — Wed, 30 Jun 2010 14:32:15 +0000

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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FDA Approves Improved Performance Of OnGuard Chest X-ray Computer-Aided Detection Technology of Riverain Medical

admin — Wed, 23 Jun 2010 11:26:33 +0000

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 Announces FDA Clearance Of Lactate Test

admin — Wed, 23 Jun 2010 11:10:58 +0000

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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