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St. Jude Medical Announces CE Mark Approval of Next-Generation Ellipse and SJM Assura High Voltage Devices

May 8, 2013 8:00 am | by The Associated Press | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--May 8, 2013--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced CE Mark approval of its next-generation Ellipse™ and SJM Assura™ portfolio of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy...

Vast Majority of Americans Would Want to Know if They Have a Serious Illness or Injury, Even If There Is No Cure, New Survey Shows

May 7, 2013 9:14 am | by The Associated Press | News | Comments

MALVERN, Pa.--(BUSINESS WIRE)--May 7, 2013--Amidst ongoing national debate about healthcare costs, new research unveiled today by Siemens Healthcare shows that the vast majority of Americans (92 percent) agree that “the value of knowing exactly what is wrong with their health is as important as...

Medtronic Announces FDA Approval of New Portfolio Of Next-Gen Cardiac Resynchronization Therapy Devices, Implantable Cardioverter-Defibrillators

May 6, 2013 10:18 am | by Medtronic | News | Comments

Medtronic, Inc. has announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of its newest cardiac devices: the Viva® portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).

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St. Jude Medical Enrolls First Patient in Next-Generation Quadra Study

May 3, 2013 9:46 am | by Business Wire | News | Comments

St. Jude Medical, a global medical device company, today announced first enrollment of its MultiPoint Pacing clinical study to build upon its first- to-market Quadripolar Pacing System. Patients will be implanted with the Quadra Assura MP cardiac resynchronization therapy defibrillator (CRT-D) and Quartet lead to assess pacing in multiple locations in the heart.

Olympus Introduces World's Only Fully Rotatable HD Bronchoscopes

May 2, 2013 11:44 am | by PRNewswire | News | Comments

Olympus, a precision technology leader in designing and delivering innovative Medical and Surgical solutions, among other core businesses, announced today the commercial availability of its 510(k) cleared BF-190 bronchoscopes. The new BF-190 bronchoscopes offer unparalleled maneuverability and flexibility through the combination of their unique Rotary Function and wider tip angulation...

Medtronic Reports Initial Implants of Novel Stent Graft for Aortic Aneurysms Involving Branch Vessel

April 29, 2013 4:32 pm | News | Comments

Vascular specialists at Carolinas HealthCare System in Charlotte, N.C., and the Cleveland Clinic in Ohio recently performed the initial implants of a novel stent graft system from Medtronic as part of a U.S. Food and Drug Administration initiative designed to encourage more early-stage clinical research on new medical devices in the United States.

BD Diagnostics Advances Commitment to a Fully Integrated Microbiology Solution with New Agreement

April 26, 2013 2:19 pm | by Bio-Medicine.Org | News | Comments

SPARKS, Md. , April 27, 2013 /- BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced today an international distributor agreement with Bruker Daltonics Inc. to sell and provide front-line technical support for the co-labeled BD™ Bruker MALDI Biotyper™ System. Microbial identification and antimicrobial susceptibility testing is the end-poin...

Shareholders Criticize J&J Management for Lapses

April 26, 2013 10:56 am | by Linda A. Johnson, AP Business Writer | News | Comments

Several Johnson & Johnson shareholders took the health care giant to task during its annual meeting Thursday, criticizing management for repeated product recalls, ethical lapses and excessive executive pay.       

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Ethicon Launches Next Generation Energy Device at American Society of Colon and Rectal Surgeons’ Annual Meeting

April 25, 2013 8:30 am | by The Associated Press | News | Comments

To expand choice and help surgeons provide greater precision, Ethicon Endo-Surgery, Inc. today announces the launch of the HARMONIC ACE + Shears with Adaptive Tissue Technology (HARMONIC ACE + Shears), the next generation product in the best-in-class HARMONIC portfolio of ultrasonic surgical devices that can handle multiple surgical jobs

ARCA biopharma and Medtronic to Collaborate on Atrial Fibrillation Clinical Trial for Gencaro

April 22, 2013 8:00 am | by The Associated Press | News | Comments

BROOMFIELD, Colo.--(BUSINESS WIRE)--Apr 22, 2013--ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases, today announced that it has entered into an agreement with Medtronic, Inc. (NYSE:MDT), a leader in medical...

Recall: Covidien pulls ventilator batteries amid defect concerns

April 19, 2013 3:54 pm | by Mass Device | News | Comments

Massachusetts-based medical device maker Covidien announced a voluntary recall of certain Power Pac batteries distributed with its Newport HT70 and HT70 Plus ventilators, according to an FDA notice. Covidien launched the recall in response to reports that some batteries were resorting to back-up power sooner than expected while operating on the Power Pac battery.

Class I Medical Device Recall: Stryker Orthopaedics - ShapeMatch Cutting Guide

April 18, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Stryker Orthopaedics has become aware of potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. The parameters of the manufactured cutting guides did not meet the surgeon’s pre-operative planning parameters entered via the web application.

Johnson & Johnson Lands Jury's Favor in Second Metal-on-Metal Hip Lawsuit

April 17, 2013 12:16 pm | by Mass Device | News | Comments

A Chicago jury this week jury ruled in favor of healthcare giant Johnson & Johnson (NYSE:JNJ), rejecting a patient's claims that the company was liable for injuries she allegedly sustained after receiving the metal-on-metal ASR XL hip implant. Legal News,

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Boston Scientific acquires, launches fiXate suturing system

April 15, 2013 2:41 pm | by Mass Device | News | Comments

Medical device maker Boston Scientific acquired the fiXate tissue band from Anulex Technologies, launching the suturing system right away. The fiXate device is a semi-automatic suturing system designed to secure spinal cord stimulator leads and pain pump catheters, touting deployment in under 1 minute in bench testing, according to a press release.

Layoffs ahead for Medtronic's spinal business

April 15, 2013 2:18 pm | by Mass Device | News | Comments

Medical device company Medtronic confirmed today that there are layoffs ahead for its spinal business, affecting an undisclosed number of workers at various locations. The medtech titan doesn't plan to release details until next month, but rumors are already swirling that a Warsaw, Ind., spinal facility may lose as many as 50 workers.

American College of Cardiology Journal Publishes Outcomes of Diabetes Patients Treated with Medtronic's Resolute Stent

April 15, 2013 9:06 am | by The Associated Press | News | Comments

The current issue of JACC: Cardiovascular Interventions, a peer-reviewed journal published by the American College of Cardiology, includes an article that describes how the Resolute Integrity drug-eluting stent from Medtronic became the first and only device of its kind to be approved by the FDA with a specific indication for treating the coronary artery disease of patients with diabetes mellitus.

Boston Scientific Launches Precision Spectra™ Spinal Cord Stimulator System In The United States

April 12, 2013 9:03 am | by PR Newswire | News | Comments

NATICK, Mass., April 12, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received approval by the U.S. Food and Drug Administration and is beginning a limited launch of the Precision Spectra Spinal Cord Stimulator (SCS) System.  The Precision Spectra System is the...

Medtronic Launches yet Another Back Pain Neurostim Study

April 11, 2013 2:45 pm | by Mass Device | News | Comments

Medtech titan Medtronic enrolled the initial patients in its SubQStim II pivotal clinical trial, evaluating the use of peripheral nerve stimulation in treatment of chronic back pain. The new study is the latest in a handful of neurostimulation trials launched by the medical device giant as it continues to battle rivals in the market for neurostimulation systems that treat chronic pain.

Medtronic’s Endurant ‘AAA’ Stent Graft Shows Sustained Durability in Complex Patients

April 11, 2013 11:21 am | by Medtronic | News | Comments

Presented to endovascular specialists at the 35th Charing Cross International Symposium in London, a new analysis of clinical data on the Endurant AAA Stent Graft System from Medtronic demonstrates the implanted medical device’s consistent and compelling performance in treating abdominal aortic aneurysms across a range of patient anatomies.

Patients Slap St. Jude Medical with Lawsuits over Recalled Riata Heart Wires

April 5, 2013 2:27 pm | by Mass Device | News | Comments

St. Jude Medical was slapped with multiple lawsuits in California courts yesterday over its recalled Riata defibrillator lead, alleging that the heart wires were defective and led to injuries or death for more than 30 patients. The lawsuits generally accuse St. Jude of violating both state and federal requirements for reporting issues with medical devices...

Diabetes: FDA Puts Highest-Risk Status on J&J's Animas Insulin Pump Recall

April 5, 2013 12:01 pm | by Mass Device | News | Comments

The FDA put its highest-risk category on Johnson & Johnson subsidiary Animas Corp.'s insulin pump recall over concerns that the devices may cause patient harm or even death. Certain pumps were recalled over concerns that a "component" issue could trigger a false alarm or a sudden warning requiring that the patient rewind, load and prime the device.

FDA Clears Medtronic's Affinity Fusion Blood Oxygenation System

April 2, 2013 2:49 pm | by Mass Device | News | Comments

Medtronic said the FDA granted 510(k) clearance for its Affinity Fusion blood oxygenator, used during open heart surgery to replace the function of the lungs. The Minneapolis-area medical device company, which is the world's largest pure-play medtech maker, said the Affinity Fusion is designed to filter a patient's blood to remove particles and air during oxygenation.

GE Healthcare Surpasses 500th Installation of Mobile X-ray Platform in the US

April 2, 2013 10:07 am | by The Associated Press | News | Comments

MILWAUKEE--(BUSINESS WIRE)--Apr 2, 2013--GE Healthcare (NYSE: GE) announced over 500 installations in the United States of its Optima* XR220amx and Optima XR200amx mobile x-ray systems. Globally the company has installed over 800 units. Designed to provide healthcare professionals with immediate...

Baxter Taps New Technologies, Forms Collaborations to Improve Environmental Sustainability and Access to Healthcare

April 2, 2013 9:00 am | by The Associated Press | News | Comments

DEERFIELD, Ill.--(BUSINESS WIRE)--Apr 2, 2013--Baxter International Inc. (NYSE: BAX) is incorporating innovative technologies and has recently established new partnerships in its commitment to environmental sustainability and increasing access to healthcare. Recently the company initiated...

C.R. Bard Loses Patent Round, $25M Hernia Insurance Decision

April 1, 2013 9:54 pm | by Mass Device | News | Comments

C.R. Bard revealed a 1-2 punch today when it reported another loss in its patent infringement war with W.L. Gore and an adverse insurance decision that could cost it $25 million. The medical device company said in regulatory filings that the U.S. Patent & Trademark Office issued an initial finding in its reexamination of a Bard patent for a "Prosthetic vascular graft," known as the '135 patent.

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