Sectra has recently registered a new Class 1 software medical device, Sectra DoseTrack, with the U.S. Food and Drug Administration (FDA).

Researchers have announced the results of a study which shows that among patients readmitted for congestive heart failure (CHF), a high E/e’ (a measure of elevated left ventricle filling pressure via ultrasound) at admission is significantly associated with higher 30-day readmission rates.  Focusing on lowering elevated E/e’ levels will be important to control healthcare costs and to reduce the high rates of morbidity and mortality in this patient population.

Medical Imaging U.S. Healthcare Overtesting New England Journal of Medicine

Big changes are coming to the U.S. healthcare system — some in response to the mounting scrutiny of medical imaging. New task force recommendations, the Choosing Wisely campaign and Affordable Care Act policies are all attempting to curtail overtesting — with computed tomography (CT) scans, magnetic resonance imaging (MRI) and any other screening often ordered unnecessarily — that can drive up medical costs, lead to waste and unnecessary radiation, and prompt undue anxiety about false positive results.

Researchers have announced the results of a clinical study that shows a key difference in the patient’s baseline heart size and function following transcatheter valve replacement (TAVR) that may help predict their medical outcomes. Previous work by these researchers showed that even mild paravalvular aortic regurgitation (PAR), detected by echocardiograms performed on these patients, appears to correlate with increased mortality. The current study revealed that certain baseline characteristics found on the echocardiograms could help predict which patients were more likely to have PAR.

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
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