Technology

InterValve Inc. announced that it has received 510(k) clearance to market the new V8 Aortic Valvuloplasty Balloon Catheter in the United States.

Home May 01, 2013
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Acutus Medical Inc. (ACM) announced that it has performed its First-In-Man clinical study of its cardiac catheter to provide highest-quality real-time 3-D mapping of the human heart.

Home May 01, 2013
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St. Jude Medical Inc. announced CE Mark approval and European launch of its Allure Quadra Cardiac Resynchronization Therapy Pacemaker (CRT-P). This CRT-P system offers more pacing options to deliver higher success rates, as evidenced by robust clinical data. Allure Quadra CRT-P brings the quadripolar lead technology to the pacemaker market. Quadripolar leads allow for increased implant efficiencies, which clinical data indicates can result in fewer surgical revisions. The Allure family of devices also offers heart failure (HF) diagnostics, including CorVue Impedance Monitoring, for improved patient management.

Home April 30, 2013
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The U.S. Food and Drug Administration approved Kcentra (prothrombin complex concentrate, human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.

Home April 30, 2013
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Royal has completed patient enrollment in the CHILL-MI clinical study designed to further evaluate the safety and effectiveness of the company’s InnerCool RTx endovascular cooling system in patients with ST-elevation myocardial infarction (STEMI).

Home April 30, 2013
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Cook Medical has initiated a global voluntary recall of its Zilver PTX Drug Eluting Peripheral Stent based on its investigation into a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Cook received 13 complaints of delivery system tip separation with an occurrence rate of 0.043 percent. Two adverse events, including one death, occurred in cases where a tip separation was reported.

Home April 30, 2013
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The first patient in the United States has been implanted with the Boston Scientific Corporation ImageReady MR Conditional pacing system in the SAMURAI clinical trial. The study is designed to confirm the safety and effectiveness of the system in the magnetic resonance imaging (MRI) environment. While MRI images can help clinicians make informed decisions about treatment and care, most pacemakers are not compatible with MRI technology, and therefore patients may not have access to the sophisticated scanning capabilities of the diagnostic system.

Home April 30, 2013
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Agfa HealthCare announced that Hunt Regional Healthcare, Greenville, Texas, has upgraded its Agfa HealthCare picture archive and communication system (PACS) to Impax 6.5 and installed Agfa HealthCare's Cardiology PACS and Xero Viewer to deliver a consolidated view and centralized management of patient, image and information data. With the addition of Agfa HealthCare's Xero Viewer, physicians are able to access the nearly 100,000 imaging exams and reports done each year, on virtually any Hunt Regional facility device. Because the information is web-based, physicians can access the results in real time.

Home April 29, 2013
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Cook Medical has launched a new fully-retractable .035 inch embolization coil, intended for peripheral arterial and venous embolization. Embolization is a nonsurgical, minimally invasive procedure performed by a physician to block or reduce blood flow in arteries and veins. Cook showcased the Retracta Detachable Embolization Coil at the annual Society of Interventional Radiology (SIR) meeting.

Home April 29, 2013
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A simple self-monitoring test could reduce the risk of stroke by half in thousands of people in the United Kingdom who currently take warfarin to prevent blood clots. Better access to self-monitoring of international normalized ratio (INR) levels, which measures how long it takes blood to form a clot, could also lower mortality rates by nearly two fifths,[1] reduce the number of complications and has the potential to save the U.K. National Health Service (NHS) around £62 million a year,[2] a group of members of parliament (MPs), patients and charities stated this week.

Home April 29, 2013
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The Alliance for Integrity in Medicare (AIM), a broad coalition of medical specialty, laboratory, radiation oncology, and medical imaging groups committed to ending the practice of inappropriate physician self-referral, announced that it is pleased that the updated Simpson-Bowles proposal recommends constricting the in-office ancillary services (IOAS) exception. AIM has long supported the position expressed by the Moment of Truth Project on physician self-referral.

Home April 29, 2013
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According to a new survey by Etiam, hospitals see a significant need for an organized system to manage the sizable flow of medical images many receive from beyond the enterprise. Hospitals also expressed concern about the security of the cloud, which increasingly plays a role in cross-enterprise access to this patient data.

Home April 26, 2013
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Fovia Medical Inc., and Softneta UAB are collaborating to deliver High Definition Volume Rendering to the telemedicine market.

Home April 26, 2013
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Cleaning your mouth and cleaning your arteries could be as simple as a once-a-day oral rinse if additional studies confirm preliminary findings about a new product.

Home April 26, 2013
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TriReme Medical Inc. and its affiliates (TriReme) announced that its Japanese partner, Century Medical Inc. (CMI), has received Shonin approval for the Glider PTCA balloon catheter indicated for treating the stenotic portion of coronary arteries or bypass grafts to improve myocardial perfusion. Combining a skived tip and a braided shaft, Glider is the world's only torqueable PTCA catheter and is designed to assist physicians in treating the most challenging cases such as bifurcations and highly stenosed lesions.

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