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Intravascular Imaging May Just Have Become Easier for Boston Scientific iLAB Customers
Aug 14, 2014Intravascular imaging may just have become easier for Boston Scientific (Marlborough, MA) iLAB customers. The company has launched a more powerful imaging device that could also reduce confusing workflows, shorten procedure times, and ...
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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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IMRIS Obtains TGA Regulatory Clearance for Ceiling-Mounted VISIUS iCT
Feb 28, 2014IMRIS, an image-guided therapy solutions provider, has obtained Therapeutic Goods Administration (TGA) regulatory clearance for its ceiling-mounted VISIUS intraoperative computed tomography (iCT). IMRIS, an image-guided therapy solutions ...
Tags: IMRIS, Regulatory Clearance, Intraoperative CT Solution
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FDA Grants 510(K) Clearance for Marketing of Ultrasound Pain Management Device Sam
Feb 28, 2014ZetrOZ has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the marketing of its ultrasound pain management device sam, a wearable, long-duration, ultrasonic diathermy device for use in applying deep ...
Tags: Ultrasound Therapy Device, Medicine, FDA
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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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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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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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The Cardiac Sensor Can Be Positioned at a Number of Positions on a Device
Jan 3, 2014The computing giant recently obtained a pair of new patents, one related to hover touch sensors and the other an integrated heart rate monitor that might be included in some of the company's 2014 product launches. The cardiac sensor can be ...
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Distribution Agreement Has Been Signed by Bsd Medical with Active Medical
Dec 13, 2013BSD Medical, a provider of medical systems, has signed an agreement with Active Medical for the sales and distribution of the MicroThermX Microwave Ablation line of products. Pursuant to the agreement, BSD recently commenced shipment of ...
Tags: BSD Medical, Active Medical, agreement, distribution agreement
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Approvals for Catheter and Supercross FT Microcath Has Been Obtained by Vascular Solutions
Dec 13, 2013Vascular Solutions, a medical device company, has obtained Shonin approvals from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its GuideLiner guide extension catheter and the SuperCross FT microcatheter. Japan Lifeline, ...
Tags: Vascular Solutions, medical device, MHLW, extension catheter
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Covidien Is Making an $860 Million Bet
Dec 11, 2013Covidien is making an $860 million bet that people would much rather swallow a pill-sized camera than undergo a traditional colonoscopy. Dublin, Ireland–based Covidien, announced over the weekend that it will pay $30 per share for ...
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FDA 510(K) Clearance for Sirius MRI Marker Has Been Obtained by C4 Imaging
Dec 10, 2013C4 Imaging, a US-based medical device company, has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Sirius MRI marker. Sirius is a positive-signal MRI marker that will be used following treatment of ...
Tags: C4 Imaging, Sirius MRI
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FDA 510(K) Approval for Microcyn Scar Management Hydrogel Is Obtained by Oculus
Dec 9, 2013Oculus Innovative Sciences has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its new Microcyn scar management HydroGel, intended to manage old and new hypertrophic and keloid scarring resulting from burns, ...
