News

May 14, 2014 — The Department of Health and Human Services (HHS) announced that new preliminary data show an overall 9 percent decrease in hospital-acquired conditions nationally during 2011 and...

FDA Premarket Approval PMA Clinical Study EP Lab Cath Leads Implantable Devices

The U.S. Food and Drug Administration (FDA) has approved many cardiac implantable electronic device...

The 2014 Top 10 Health Technology Hazards list raises awareness of the potential dangers associated with the use of medical devices and helps healthcare providers minimize the risk of technology-...

Medtronic Inc. announced U.S. Food and Drug Administration (FDA) approval of its Lead Integrity Alert (LIA) software for use with non-Medtronic ...

St. Jude Medical has issued a Class I recall for its Amplatzer TorqVue FX Delivery System used in transcatheter closure of atrial septal defects (ASDs). The company said in a small number of cases...

Access site complications, hemostasis management, vascular closure

Percutaneous coronary interventional (PCI) procedures are performed throughout hundreds of US institutions every day. With the increasing frequency of these procedures being performed comes an...

February 8, 2011 – The U.S. Food and Drug Administration (FDA) said Merit Medical Systems initiated a Class I recall for one lot of its Prelude Short Sheath Introducer, because the tips may detach...

The Society for Cardiovascular Angiography and Interventions (SCAI) this week published guiding principles and best practices for the development of radiation safety programs in cardiac...

December 13, 2010 – Based on emerging safety information, the pulmonary arterial hypertension (PAH) drug sitaxentan is being voluntarily withdrawn from the market. Pfizer is also discontinuing...

December 10, 2010 – The 5th annual list of the Top 10 Health Technology Hazards for 2011 is now available. The list, from the ECRI Institute, features the top health technology hazards that...

December 6, 2010 – A panel of medical imaging experts discussed medical imaging appropriateness, ionizing radiation and efforts to curb overutilization, decrease radiation dose and educate...

September 10, 2010 – Cath Labs are being encouraged this week by the U.S. Food and Drug Administration (FDA) to inspect their inventories for AngioSculpt EX Percutaneous Transluminal Coronary...

September 10, 2010 – The U.S. Food and Drug Administration (FDA) is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and...

September 2, 2010 – New research released this week is the first to find both anatomical and procedural considerations that can lead to the creation of esophageal ulcerations (ESUL) after...

August 17, 2010 – Certain batches of the St. Jude Medical 6 French Engage Introducer are being recalled because the shaft of some devices may separate from the hub. The company is advising...

July 21, 2010 – The Advancing Patient Safety Coalition sent a letter to the U.S. Food and Drug Administration earlier this month, urging the agency to immediately issue rules on unique device...

July 1, 2010 – The U.S. Food and Drug Administration (FDA) recently added a warning to the information on clopidogrel (Plavix), as a result of new information indicating that variations in genetic...

June 28, 2010 – There is a growing consensus that radiologists must ensure that patients undergoing computed tomography (CT) receive the minimum radiation dose possible to produce a medical...

May 17, 2010 – When patients present with chest pain or other high-risk symptoms of heart problems, doctors increasingly rely on nuclear imaging and computed tomography (CT) to find evidence of...

April 7, 2010 – A medical manufacturer pleaded guilty Monday to criminal violations for improper reporting of short-circuit failures of three models of its implantable cardioverter defibrillators...