News

3-d pronting, 3D printing

The FDA has recognized 3-D printing technology now exists to print medical devices and is gathering information regarding technical assessments that should be considered when it will inevitably...

Corevalve, FDA, Edwards, TAVR, TAVI, lawsuit, injunction

In a surprise move, Edwards Lifesciences Corp. and Medtronic reached an agreement this week to settle all outstanding patent litigation between the companies, including cases related to...

cardiology Inventory management

Computerized and semi-automated inventory control system technology offers a more efficient way for cardiovascular departments, especially catheterization and electrophysiology (EP) labs, to track...

Advanced Circulatory, makers of medical devices providing Intrathoracic Pressure Regulation (IPR) Therapy, will continue to work with the U.S. Food and Drug Administration (FDA) on a pathway to...

May 16, 2014 — In a move to expand significantly its portfolio of solutions for peripheral interventions, Boston Scientific Corp. has entered into a definitive agreement to acquire the...

CathMaps+ App Cath Lab Patient Engagement Mobile Devices

CathMaps demonstrated how mobile technology can provide emergency assistance and peace of mind to millions of Americans at risk for a cardiac event. 

OrbusNeich announced the launch of the Sapphire II NC coronary dilatation catheter, a non-compliant balloon catheter engineered to cross tight lesions, outside the United States.

May 14, 2014 — Detroit Medical Center (DMC) Harper Hospital presented a live CorPath robotic-assisted percutaneous coronary intervention (PCI), or coronary angioplasty, during the American College...

Elixir Medical Corp. DESolve 100 CE mark

Elixir Medical Corp. received CE mark approval for its DESolve 100 Novolimus Eluting Bioresorbable Coronary Scaffold System.

IABP, Datascope, Maquet, FDA recall

Datascope Corp./Maquet initiated a voluntary worldwide field correction of some of its intra-aortic balloon pumps (IABPs) due to a potential mechanical failure of the fan assembly associated with...

InspireMD Inc. initiated a Voluntary Field Action (VFA) following recent reports of MGuard Prime EPS (embolic protection systems), stent dislodgements. 

The webinar "Implementing Robotic PCI — Why and How to Start a Successful Program" defines optimal strategies for launching a successful robotic percutaneous coronary intervention (PCI) program....

CleanerXT Argon Medical Devices Inc. Thrombectomy Devices Deep Vein Thrombosis

Argon Medical Devices Inc. began marketing the CelanerXT rotational thrombectomy system as a new addition to the Cleaner family of dialysis products. 

May 7, 2014 — Women face greater limits on their lifestyle and have more severe symptoms as a result of peripheral artery disease (PAD), but minimally invasive procedures used to unclog arteries...

HeartWare Ltd. Ventricular Assist Device Correction Batteries

HeartWare Intl. Inc. issued a voluntary Urgent Medical Device Correction related to all HeartWare Ventricular Assist System batteries, product codes 1650 and 1650-DE. 

GE Healthcare Discovery IGS 740 Mobile Angiography System FDA Approval

GE Healthcare received U.S. Food and Drug Administration (FDA) clearance for its Discovery IGS 740, a new rail-free mobile angiography system with a 41x41 cm detector. 

May 6, 2014 — Google Glass and its potential to improve patient care will be the focus of a first-of-its-kind special session at the 2014 Society for Cardiovascular Angiography and...

May 6, 2014 — Siemens Healthcare announced the U.S. Food and Drug Administration (FDA) has cleared the Artis one angiography system, optimized for broad clinical utilization. The Artis one is...

Gore Tag Thoracic Branch Endoprosthesis LSA Feasibility Study Clinical Trial

W. L. Gore & Associates (Gore) announced that Himanshu Patel, M.D. and David Williams, M.D. at The University of Michigan enrolled the first patient in the Gore TAG Thoracic Branch...

Late-Breaking Trials SCAI May 2014

The Society for Cardiovascular Angiography and Interventions (SCAI) announced the late-breaking clinic al trial data presentations for it its upcoming 2014 Scientific Sessions, May 28-31, in Las...