Items Tagged with 'FDAnews Device Daily Bulletin'

Newborn screening for cystic fibrosis is associated with clinical benefit and reduced treatment needs compared with clinical diagnosis, according to an article in the April 7 issue of The Lancet.

Bloodstream infection in patients with permanent pacemakers or implantable cardioverter-defibrillators may be caused by device infection, a recent study found.

Factors such as geographic location, a hospital's procedural volume or a patient's insurance type have major effects on the type of stent treatment patients receive, according to a recent study from the Mayo Clinic.

Computerized tomography (CT) imaging after intravenous injection of a novel contrast agent detected macrophages in atherosclerotic plaques of rabbits in a study appearing in the May issue of Nature Medicine.

Medtronic announced the formation of Medtronic CardioVascular, a new global business combining the firm's vascular and cardiac surgery businesses.

The HHS Office of Inspector General (OIG) inspected durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) providers in South Florida in late 2006 and found nearly half were not in compliance with certain Medicare standards.

Johnson & Johnson (J&J) announced it submitted a premarket approval (PMA) application for its adjustable gastric band, an implantable device to treat morbid obesity.

Companies should begin the initial registration process to participate in Medicare's durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program, the Centers for Medicare & Medicaid Services (CMS) said.

The European Society of Radiology (ESR) and the European Federation of Neurological Associations last month announced the launch of the Alliance for MRI to stop European Union (EU) legislation from inadvertently preventing the use of magnetic resonance imaging (MRI).

Physicians only consider patients' out-of-pocket costs 40.2 percent of the time when selecting diagnostic tests, according to a study published in the April 9 issue of the Archives of Internal Medicine.