Philips Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its AlluraClarity live image guidance system in the United States.

North Shore University Hospital (NSUH) announced it has installed the most advanced cardiac computed tomography (CT) scanner to help diagnose heart disease and a patient’s risk for heart attack.

AirStrip announced the first phase of its strategic participation in Microsoft’s AppsForSurface program. As part of the program, the company will launch and make available AirStrip ONE Cardiology not only on Windows 8.1-enabled mobile devices, but also on laptops and desktops.

FDA US device innovation

With recent medical device advances have come increasing concerns about the ability of the United States to remain at the forefront of research, especially in light of stringent FDA policies regarding clinical trials and device approval. This concern was the subject of keynote addresses by Jeffrey Popma and Robert (Chip) Hance at the 2013 SCAI Scientific Sessions.
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The year 2013 has brought us several important clinical trials that have changed the way interventional cardiologists approach and treat patients with stable coronary artery disease. These trials were a major focus at the “Hottest Topics 2013” session at the Society for Cardiovascular Angiography and Interventions (SCAI) 2013 Scientific Sessions

Medstreaming launched its new Graphic Based Surgical Application for desktop and mobile platforms at the Vascular Annual Meeting (VAM) May 30 – June 1, 2013 in San Francisco. The structured operative note application uses anatomical sketches to enable surgeons and interventionalists to easily generate structured reports based on graphical workflow.

UltraSPECT, a leading provider of nuclear medicine (NM) image reconstruction technology that reduces radiopharmaceutical dose and acquisition time, announced the installation of its proprietary Wide Beam Reconstruction (WBR) software at nearly ten healthcare facilities. These installations come as a result of the recent agreement between UltraSPECT and radiopharmaceutical provider PharmaLogic, under which PharmaLogic is offering the WBR software as part of its patient-centered approach. In just a short time, PharmaLogic has successfully approached dozens of NM imaging facilities about the advanced WBR software which improves patient safety and technologist safety, while providing higher efficiency and optimum image quality. 

One-year data from an Italian multicenter randomized controlled trial of the In.Pact Falcon drug-eluting balloon from Medtronic Inc. demonstrate positive and durable clinical results with the novel angioplasty device in the treatment of stenotic de novo lesions in small coronary arteries, according to a presentation made at EuroPCR.

Primary end-point results from the BIOFLOW-II clinical study demonstrating the non-inferiority of the Biotronik Orsiro Hybrid Drug-Eluting Stent compared to Abbott's Xience Prime. These results were presented in a late-breaking clinical trials session at the EuroPCR congress in Paris by principal investigator, Professor Stephan Windecker, M.D. of University Hospital Bern, Switzerland.

 
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