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Although the highly saturated picture archiving and communication systems (PACS) segment is slowing growth in the U.S. imaging informatics market, a few niche areas are advancing forming new growth areas.

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The U.S. Food and Drug Administration (FDA) approved Lumason (sulfur hexafluoride lipid microsphere) for patients whose ultrasound image of the heart (echocardiograms) are hard to see with ultrasound waves.

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Infraredx Inc. announced that its dual-modality intravascular imaging technology, TVC Imaging System, and its TVC Insight Catheter received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW).

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Presented for the first time at the 2014 Transcatheter Cardiovascular Therapeutics (TCT) conference, the latest clinical and economic data on the IN.PACT Admiral drug-coated balloon (DCB) from Medtronic Inc. augments an already robust body of evidence that continues to drive a reconsideration of the standard of care for peripheral artery disease (PAD) in leg arteries above the knee.

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Covidien announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx defibrillators.

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October 13, 2014 — After reviewing updated data and analysis for the Boston Scientific Watchman left atrial appendage (LAA) closure device, the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in favor of the device. By a vote of 6 to 5 (with 1 abstention) the panel concluded the benefits of the Watchman device outweigh the potential risks.

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Developed for practices and clinics that do not have a PACS or other disaster recovery solution, Informity uses cloud-based technology to automatically and continuously back up patient information, images and system settings on the ImagePilot Sigma and ImagePilot Aero. It assures business continuance with a one button restore of the entire system.

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A report released by the Department of Health and Human Services projects that hospitals will save $5.7 billion this year in uncompensated care costs because of the Affordable Care Act, with states that have expanded Medicaid seeing about 74 percent of the total savings nationally compared to states that have not expanded Medicaid.

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A study using a new imaging tool, optical coherence tomography (OCT), offered a new look at the composition of carotid artery disease and has the potential to alter how physicians understand and treat the disease, a leading cause of stroke.

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Although cardiovascular disease is largely avoidable through lifestyle modifications, it remains the nation’s number one cause of death. While annual wellness exams offer physicians the chance to advise patients on modifying cardiac risk factors, that advice can easily get lost given the amount of information covered during a routine check-up.

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“Once patients have survived cancer, they don't die from cancer, they die from heart disease. Cardio-oncology is about making sure that doesn't happen," said Juan Carlos Plana, M.D.

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C. R. Bard Inc. announced the U.S. Food and Drug Administration (FDA) approval of the Lutonix 035 drug-coated balloon (DCB) catheter for percutaneous transluminal angioplasty (PTA) after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6mm.

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October 10, 2014—Mitralign Inc. reported on the successful use of its technology to perform a percutaneous repair on a patient with tricuspid regurgitation (TR). Prof. Dr. med. J. Schofer of the Medicare Center and Department for Percutaneous Interventions of Structural Heart Disease, Albertinen Heart Center, Hamburg, Germany; and Rebecca Hahn, M.D., director of interventional echocardiography, Columbia University Medical Center / New York Medical Center / New York Presbyterian Hospital, presented at the PCR London Valves Conference and detailed the procedure—a percutaneous bicuspidization of the tricuspid valve, successfully converting a regurgitating tri-leaflet valve into a functioning bi-leaflet valve. The German regulatory body BfArM approved the patient for a compassionate use exemption, as no other options were available. The successful procedure was performed at the Albertinen Heart Center in Hamburg. The Mitralign product is currently being evaluated in clinical trials for an indication in functional mitral regurgitation. The device is not approved for sale or distribution.

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October 10, 2014 — Despite ongoing commercial challenges in 2013, the global medtech industry’s financial performance held steady at the relatively low levels of growth that have become common in recent years. But even as the industry grapples with these market and regulatory pressures, it faces a potential growing challenge: the threat of commoditization, according to new findings outlined in EY’s annual medical technology report, Pulse of the industry: differentiating differently, released today.

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A KLAS report revealed a lack of widespread integration with EMRs continues to limit the effectiveness of order sets and care plans.

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