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FDA Clearance
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The Afrezza-Branded Inhaled Insulinwill Be Introduced in The U.S
Aug 15, 2014The Afrezza-branded inhaled insulin from Mannkind (Valencia, CA) will be introduced in the United States in 2015 after Sanofi entered into an agreement with the company, offering up to $925 million for the rights to sell the product ...
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FDA Raising Cancer Concerns Over How Robotic Hysterectomies Are Performed.
Apr 23, 2014Intuitive Surgical stock fell 11.5% in value on Wednesday after a disappointing quarterly earnings report and the FDA raising cancer concerns over how robotic hysterectomies are performed. The Sunnyvale, CA–based maker of da Vinci ...
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Biofortuna Receives 510(K) Approval From FDA for Its Line of Sspgo HLA PCR Kits
Feb 28, 2014UK-based Biofortuna has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its line of SSPGo HLA PCR kits, designed for transplantation genotyping and identification of genes that may be associated with various ...
Tags: Biofortuna, Medicine
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Hospi Announced Receipt of 510(K) Clearance From The U.S
Feb 13, 2014Hospi Corporation, a privately-held medical device company focused on nurse invented products that optimize patient care, today announced receipt of 510(k) clearance from the U.S. Food and Drug Administration for its first product, the Macy ...
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JustRight Surgical Has Received 510 Clearance
Feb 13, 2014JustRight Surgical, a micro-laparoscopic medical device company devoted to miniaturizing surgical instrumentation, has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its JustRight™ 5mm Stapler. The ...
Tags: Health, Medicine, surgical instrumentation
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InControl Medical Received FDA Clearance for Their Proprietary, patented, InTone®MV
Feb 12, 2014InControl Medical, LLC, a women's health company focusing on female urinary incontinence, has received FDA clearance for their proprietary, patented, InTone®MV, providing women who suffer with vaginal atrophy a smaller, more comfortable ...
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Admedus Obtains FDA Clearance Market an Advanced Cardiovascular Scaffold, Cardiocel
Feb 12, 2014Admedus has obtained the US Food and Drug Administration (FDA) clearance to market an advanced cardiovascular scaffold, CardioCel, which is designed to repair and treat a range of cardiovascular and vascular defects. The approval is ...
Tags: Cardiocel, FDA Clearance
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Atheromed Gets Approval From FDA for Phoenix Atherectomy System
Feb 7, 2014AtheroMed has obtained marketing approval from the US Food and Drug Administration (FDA) for its Phoenix atherectomy system for treating peripheral artery disease (PAD). Phoenix atherectomy system is a peripheral atherectomy catheter ...
Tags: FDA, pPAD, debulked material, Archimedes Screw
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Affymetrix Received 510 Clearance From The U.S. Food and Drug Administration
Jan 21, 2014Affymetrix, Inc. (NASDAQ: AFFX) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its CytoScan® Dx Assay. This assay is intended for the postnatal detection of DNA copy ...
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Argon Announced That The Company Has Received Clearance From Food and Drug Administration
Jan 16, 2014Argon Medical Devices, Inc. announced today that the company has received clearance from the US Food and Drug Administration to begin marketing the Option™ELITE retrievable inferior vena cava (IVC) filter with a new over-the-wire ...
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Aligned to Help Move Reproductive Health Management Forward
Jan 16, 2014Aligned with its commitment to help move reproductive health management forward, Beckman Coulter Diagnostics has received clearance for its new Access Total βhCG (5th IS) assay from the U.S. Food and Drug Administration (FDA) 510(k), ...
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Varian Medical Systems Has Received FDA 510(K) Clearance for Its Proton Therapy System
Jan 15, 2014Varian Medical Systems (NYSE: VAR) has received FDA 510(k) clearance for its updated ProBeam™ proton therapy system. Varian's ProBeam system gives clinicians options for delivering dose precisely in order to minimize dose to healthy ...
Tags: Health, Medicine, Varian Medical Systems
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K2M Held Spinal Device Company in The World Focused on Developing Innovative Solutions
Jan 13, 2014K2M, Inc., the largest privately held spinal device company in the world focused on developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced it has received 510(k) ...
Tags: K2M, CAYMAN Minimally Invasive, CAYMAN Plate System, 510(k)clearance
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Meridian's TRU FLU Assay Received FDA Clearance for an Analytical Sensitivity Claim
Jan 10, 2014Meridian Bioscience, Inc. (NASDAQ: VIVO) today announced that the company's TRU FLU® assay received FDA clearance for an analytical sensitivity claim for the novel avian Influenza H7N9 strain, A/Anhui/1/2013. TRU FLU® is a rapid ...
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Electromed Has Received Notification From The U.S. Food and Drug Administration
Jan 3, 2014Electromed, Inc. (NYSE MKT: ELMD), a global medical device company, today announced it has received notification from the U.S. Food and Drug Administration that its next generation SmartVest® Airway Clearance System, the model ...
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