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. 

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). 

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.

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.

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.

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.

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.

 

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.

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. 

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