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BioSphere Medical, Inc., a medical device company that pioneered the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a procedure called embolization, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the BioSphere Medical Sequitor Steerable Guidewire ("Sequitor") Premarket Notification (510K) that allows Sequitor to be marketed in the United States.
Results Presented at the Scientific Session of the 66th American Diabetes Association (ADA) Show Median Relative Absolute Difference of 12.9% in a Wide Range of Glucose Levels.
At the ISMICS (International Society For Minimally Invasive Cardiothoracic Surgery) 9th Annual Scientific Meeting, ESTECH, Inc. of San Ramon, CA, announced it has entered into a U.S. Distribution Agreement with Neoprobe Corporation (OTCBB: NEOP) for the Cardiosconix Quantix/OR blood flow measurement system.
BioView Ltd., which develops, manufactures and supplies cell imaging equipment, biological kits and software, has filed an application for US Food and Drug Administration (FDA) approval to market its breast cancer early diagnosis system.
Meridian Bioscience, Inc. today announced that it has received CLIA waiver status from the U.S. Food and Drug Administration (FDA) for its ImmunoCard STAT!(R) HpSA test, a rapid single-use test for the diagnosis of Helicobacter pylori (H. pylori) infection.
The International Trade Commission (ITC) is initiating an investigation of patent infringement for insulin delivery devices under section 337 of the Tariff Act of 1930, the Commission announced recently.
Hamilton Medical is initiating a nationwide voluntary recall of three types of RAPHAEL ventilators with older generation software, the FDA said in a recent posting on its website.
The Centers for Medicare & Medicaid Services (CMS) recently published prices for 30 diagnosis-related groups (DRGs) and procedures -- a move that will increase pressure on the device
industry to lower prices, experts say.
The NanoEurope, which will be held from September 12-14, 2006, is making yet another stride forward: Its cooperation with leading partners from the key industries of Textiles, Plastics, and Medical Devices demonstrates the closeness to the marketplace of the Fair and the Conference alike.