Advertisement
Device Companies
Subscribe to Device Companies

The Lead

FDA Approval for New Defibrillators and Heart Failure Devices

April 16, 2014 10:17 am | by Boston Scientific | News | Comments

Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. The newly approved devices include the DYNAGEN MINI and INOGEN MINI ICDs, as well as...

Preliminary Injunction Against Guidezilla Catheter Vacated by Federal Circuit

April 16, 2014 10:09 am | by Vascular Solutions | News | Comments

Vascular Solutions, Inc. announced that a three judge panel of the U.S. Court of Appeals for the...

Imaging’s Role in Cancer Research

April 14, 2014 2:08 pm | by Gregory Sorensen, MD, President and CEO, Siemens Healthcare North America | Blogs | Comments

Anyone who hears the words, “You have cancer,” wants to hear next that they will survive. ...

Abbott Receives 510(k) for Test to Help Diagnose Diabetes

April 14, 2014 11:31 am | by Abbott | News | Comments

Abbott announced today that its new ARCHITECT Clinical Chemistry Hemoglobin A1c (HbA1c) test -...

View Sample

FREE Email Newsletter

Covidien Gets FDA 510(k) Clearance for Kangaroo Feeding Tube with IRIS Technology

April 14, 2014 11:20 am | by Covidien | News | Comments

Covidien today announced U.S. Food and Drug Administration 510(k) Clearance for the Kangaroo feeding tube with IRIS Technology. This first-of-its-kind camera-equipped disposable feeding tube is designed to enhance patient safety by providing...

Medtronic to Appeal Federal District Court Ruling

April 14, 2014 11:07 am | by Medtronic Inc. | News | Comments

The Federal District Court of Delaware today granted in part Edwards Lifesciences' motion for a preliminary injunction that prevents Medtronic, Inc. from selling or offering to sell its CoreValve System in the United States. Today's ruling has...

Opportunities and Challenges of Doing Business in Companion Diagnostics

April 14, 2014 9:56 am | by Richard Park, Contributing Editor | Blogs | Comments

For my occasional series of blogs examining various facets of the companion diagnostics market, I asked some of the major IVD manufacturers to share their thoughts and opinions on the current opportunities and challenges in companion...  

Advertisement

Covidien Implements Voluntary Recall of its Pipeline Embolization Device and Alligator Retrieval Device

April 11, 2014 10:14 am | by Covidien | News | Comments

Covidien plc has announced that it has notified customers of a voluntary recall to address an issue with certain lots of its Pipeline Embolization Device and Alligator Retrieval Device where the polytetrafluoroethylene (PTFE) coating applied...

First Patient Enrolled in Clinical Registry Assessing Boston Scientific Vercise Deep Brain Stimulation System in Patients with Parkinson's Disease

April 11, 2014 10:07 am | by PR Newswire | News | Comments

Boston Scientific Corporation has enrolled the first patient in a new registry to evaluate clinical outcomes and the economic value of the Vercise™ Deep Brain Stimulation (DBS) System in patients with Parkinson's disease. DBS is a surgical...

First Patient in U.S. to Receive MRI Scan in Clinical Study of MRI-Compatible Pacemaker

April 10, 2014 8:36 pm | by PR Newswire | News | Comments

Providence Saint Joseph Medical Center is the first hospital in the nation to conduct an MRI scan of a patient implanted with a new MRI-compatible pacemaker – a breakthrough because metal implants often exclude patients from this imaging...

Medtronic CRT Devices Now Approved to Treat Patients with AV Block and Reduced Heart Function

April 10, 2014 7:33 pm | by The Associated Press | News | Comments

Medtronic, Inc. has announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for biventricular (BiV) pacing with Medtronic cardiac resynchronization therapy-pacemakers and -defibrillators (CRT-P and CRT-D)...

Philips Handheld Blood Test Shows Further Promise in Clinical Setting

April 10, 2014 10:37 am | by Philips Electronics | News | Comments

Royal Philips has completed its first field study for its Minicare handheld cardiac Troponin-I (cTn-I) blood test, demonstrating the platform’s potential to produce lab-equivalent results with finger prick samples within minutes. The...

Advertisement

Abbott Completes Enrollment of AbsorbT Randomized Clinical Trials in the U.S., Japan, and China

April 10, 2014 8:31 am | by The Associated Press | News | Comments

Abbott has announced it has completed enrollment of three clinical trials to support approvals of the company's revolutionary AbsorbT Bioresorbable Vascular Scaffold (BVS) in the United States, Japan and China. Combined, the U.S., Japan and...

St. Jude Medical Recognized as Innovative Technology Supplier of the Year

April 9, 2014 12:19 pm | by St. Jude Medical Inc. | News | Comments

St. Jude Medical, Inc., a global medical device company, was recognized by Novation as the 2013 Innovative Technology Supplier of the Year. Novation members selected the St Jude Medical ILUMIEN PCI Optimization System based on their experience...

New Anspach High Speed Drill System Debuts at AANS Annual Meeting

April 9, 2014 10:46 am | by DePuy Synthes Power Tools | News | Comments

DePuy Synthes Power Tools* announced the global launch of the Anspach EG1 High Speed Electric System, a next generation high-speed electric drill with multiple attachments and accessories, designed for use in neurosurgery, otology and spinal...

Cardiac Device Keeps Heart Going

April 8, 2014 3:15 pm | by Jennifer R. Lloyd, San Antonio Express-News | News | Comments

With a weak heart muscle and heart valve problems, Ruben Rivera said he was apprehensive about having a new type of battery-powered defibrillator implanted under his skin that could shock his heart if it sensed an irregular rhythm. But the...

GE Healthcare Receives FDA Clearance For Q.Clear Technology

April 8, 2014 9:34 am | by PR Newswire | News | Comments

GE Healthcare, a unit of General Electric Company, has announced that it received U.S. FDA 510(k) clearance of its Q.Clear technology – technology that can provide up to two times improvement in both quantitative accuracy and image quality...

Advertisement

Boston Scientific's Endoscopic Ultrasound Needle Is for Use During Fine Needle Aspiration Procedures

April 7, 2014 6:31 pm | by PR Newswire | News | Comments

Boston Scientific Corporation has received clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which is now globally available for Endoscopic Ultrasound-Fine Needle...

'IN.PACT Admiral' Drug-Coated Balloon from Medtronic Outperforms Standard Angioplasty

April 7, 2014 10:34 am | by Medtronic Inc. | News | Comments

Patients with peripheral artery disease in the upper leg experienced significantly better outcomes at 12 months after treatment with the IN.PACT Admiral drug-coated balloon from Medtronic, Inc. than with standard balloon angioplasty, according to a landmark...

Installation of World's First High-Field MRI-Guided Radiation Therapy System

April 7, 2014 10:27 am | by Elekta | News | Comments

Elekta, Royal Philips and University Medical Center (UMC) Utrecht (the Netherlands) announced today that the initial components of the world's first high-field magnetic resonance imaging (MRI) guided radiation therapy system are being installed...

Transvaginal Mesh Patient Awarded $1.2 Million in Ethicon Mesh Lawsuit, Announces Baron and Budd

April 4, 2014 11:44 am | by The Associated Press | News | Comments

A Dallas jury found transvaginal mesh manufacturer Ethicon and its parent company Johnson & Johnson liable for defects associated with the company’s TVT-O transvaginal mesh sling. The mesh patient, Linda Batiste, was awarded $1.2 million...

World's First and Only Upgradeable Spinal Cord Stimulation System Receives FDA Approval

April 4, 2014 8:42 am | by The Associated Press | News | Comments

St. Jude Medical, Inc., a global medical device company, today announced the approval of its Protégé IPG from the U.S. Food and Drug Administration (FDA). Protégé is the first and only neurostimulation system that allows spinal cord stimulation...

J&J Accepts $4B Carlyle Offer for Diagnostics Unit

April 2, 2014 11:52 am | by The Associated Press | News | Comments

Johnson & Johnson has accepted an offer of about $4 billion from the private equity firm The Carlyle Group to buy its Ortho-Clinical Diagnostics business. J&J said Monday that the deal for the blood-testing unit should close by mid...

New Long-term Data Demonstrate Patients with Mild Heart Failure Sustained Lower Mortality Rates after Receiving Boston Scientific CRT Defibrillators

March 31, 2014 12:27 pm | by Boston Scientific | News | Comments

In the longest follow-up to date of cardiac resynchronization therapy (CRT) for mild heart failure patients, Boston Scientific Corporation's (NYSE: BSX) exclusively sponsored and landmark Multicenter Automatic Defibrillator Implantation Trial...

GE Healthcare Debuts Connected Cardiovascular Care at ACC 2014

March 31, 2014 12:04 pm | by GE Healthcare | News | Comments

GE Healthcare, a division of General Electric Company (NYSE: GE), today showcased a suite of connected cardiovascular innovations – including several new and advanced imaging technologies and software capabilities – at the 63rd annual American College...

Study Backs Nonsurgical Way to Fix Heart Valves

March 31, 2014 11:52 am | by Marilynn Marchione, AP Chief Medical Writer | News | Comments

A new study gives a big boost to fixing a bad aortic valve, the heart's main gate, without open-heart surgery. Survival rates were better one year later for people who had a new valve placed through a tube into an artery instead. The results...

Photos of the Day: Repairing the Heart Without Surgery

March 31, 2014 11:51 am | by The Associated Press | News | Comments

A new study gives a big boost to fixing a bad aortic valve, the heart's main gate, without open-heart surgery. Survival rates were better one year later for people who had a new valve placed through a tube into an artery instead...   

Stryker Sustainability Solutions Brings Record-Setting $255 Million In Reprocessing Savings To U.S. Hospitals

March 31, 2014 8:24 am | by PR Newswire | News | Comments

Growth of Stryker Sustainability Solutions' single-use medical device reprocessing and remanufacturing services produced a record-setting $255 million in supply cost savings for its more than 2,500 hospital and health system customers in...

Medtronic CoreValve® System Demonstrates Long-Term Durability

March 31, 2014 8:22 am | by The Associated Press | News | Comments

Medtronic, Inc. has announced the final follow-up results from the CoreValve® CE Pivotal Study, which demonstrated excellent long-term durability at four years in patients with severe aortic stenosis who were treated with the self-expanding...

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading