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Supreme Court Ruling Leaves Medical Device Excise Tax in Place: Kalorama

June 28, 2012 3:06 pm | News | Comments

While supporters and opponents of President Obama’s healthcare reform legislation let out boos or cheers for the recent decision of the United States Supreme Court, one industry will not be pleased, according to Kalorama Information. The healthcare market research publisher says that the medical device industry will face additional costs

Generation Opportunity President Paul T. Conway Statement: Scotus Health Care Decision's Impact on Young Americans

June 28, 2012 2:19 pm | News | Comments

Generation Opportunity President Paul T. Conway, former Chief of Staff for the US Department of Labor and former Deputy Secretary of Health and Human Resources for the Commonwealth of Virginia, has issued the following statement regarding the Supreme Court's decision today on the Patient Protection and Affordable Care Act:

Cook Medical Statement on Supreme Court Ruling on Affordable Healthcare Act

June 28, 2012 2:06 pm | News | Comments

With the U.S. Supreme Court ruling upholding the constitutionality of the Affordable Care Act (ACA), Cook Medical now calls for the U.S. Senate to repeal the 2.3 percent medical device excise tax included in that legislation.

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EndoGastric Solutions Announces Second Randomized Controlled Trial Comparing TIF Procedure to PPI Therapy for the Treatment of GERD

June 28, 2012 2:02 pm | News | Comments

EndoGastric Solutions® (EGS), the leader in endoluminal treatment of Gastroesophageal Reflux Disease (GERD), today announced the start of the TIF versus Medical Proton Pump Inhibitor (PPI) Management of Refractory GERD Symptoms (TEMPO) trial. TEMPO, the second in a series of randomized trials involving TIF, is designed to assess the safety and efficacy of the procedure—performed using EndoGastric Solutions’ EsophyX® device—as compared to PPI therapy to treat bothersome symptoms associated with chronic GERD.

NLT SPINE Reports Positive Clinical Results for PROW FUSION, Its Lumbar Interbody Fusion Device for Minimally Invasive Spine Surgery

June 28, 2012 1:57 pm | News | Comments

NLT SPINE, a developer of products for Minimally Invasive Spine Surgery (MISS) and percutaneous procedures, announced today that initial results from clinical experience with its PROW FUSION device are highly positive.

Patients Are the Victors in Affordable Care Ruling, Says American Heart Association CEO

June 28, 2012 12:10 pm | News | Comments

American Heart Association CEO Nancy Brown issued the following statement today on the U.S. Supreme Court's ruling upholding the Affordable Care Act: "The historic decision handed down today will benefit America's heart health for decades to come. Questions about the Affordable Care Act's constitutionality have overshadowed the law's progress. With this ruling, that uncertainty has finally been put to rest.

HSCA Statement on Supreme Court Affordable Care Act Decision

June 28, 2012 11:55 am | News | Comments

Healthcare Supply Chain Association (HSCA) President Curtis Rooney today released the following statement regarding the Supreme Court’s decision to uphold the Affordable Care Act: "Now that the Supreme Court has rendered its decision on the Affordable Care Act and the national conversation can return to healthcare reform centered on cost containment, hospitals and healthcare providers will rely more than ever on the billions of savings that their group purchasing organizations (GPOs) provide every year.

Lilly Statement on Affordable Care Act Ruling by Supreme Court

June 28, 2012 11:21 am | by The Associated Press | News | Comments

Following is a statement from John C. Lechleiter, Ph.D., chairman, president, and chief executive officer of Eli Lilly and Company, regarding today's U.S. Supreme Court ruling to uphold the Affordable Care Act: "Following today's decision by the U.S. Supreme Court on the Affordable Care Act,...

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Applying Tech: Cardiovascular

June 27, 2012 5:38 pm | Articles | Comments

How are you influencing cardiovascular devices?

Cefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment

June 26, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Health care professionals should adjust the dosage of cefepime in patients with creatinine clearance less than or equal to 60 mL/min.

FDA approves SonixGPS needle guidance technology for vascular access procedures

June 26, 2012 5:49 am | News | Comments

Ultrasonix Medical Corporation has received approval from the US Food and Drug Administration for its SonixGPS technology for Vascular Access procedures.

Pitt Develops Biodegradable Artery Graft to Enhance Bypass Surgeries

June 25, 2012 10:58 am | News | Comments

With the University of Pittsburgh’s development of a cell-free, biodegradable artery graft comes a potentially transformative change in coronary artery bypass surgeries: Within 90 days after surgery, the patient will have a regenerated artery...

Cook Medical Sponsors First Clinical Study to Examine New Endovascular Technique

June 25, 2012 10:30 am | News | Comments

Clinical investigators are for the first time examining the retrograde tibiopedal interventional approach, an endovascular technique that has the potential to reduce the rate of leg amputations by as much as 50 percent in patients with critical limb ischemia...

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Discovery of ‘Master Molecule’ Could Improve Stem Cell Treatment for Heart Attacks

June 25, 2012 7:34 am | News | Comments

Johns Hopkins researchers have discovered that a single protein molecule may hold the key to turning cardiac stem cells into blood vessels or muscle tissue, a finding that may lead to better ways to treat heart attack patients.

Epilepsy Organizations Award Funding for New Devices to Treat, Detect, and Monitor Epilepsy Conditions

June 25, 2012 6:45 am | News | Comments

The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) today announced the latest grant recipients of their New Therapy Grants Program, a unique joint venture of the two non-profit epilepsy organizations to advance clinical development...

Covidien Announces Global Launch of Nellcor SpO2 Module for Philips IntelliVue Patient Monitors

June 25, 2012 6:11 am | News | Comments

Covidien, a leading global provider of healthcare products and recognized innovator in patient monitoring and respiratory care devices, today announced the launch of its Nellcor™ SpO2 single parameter module for use with the Philips IntelliVue patient monitoring platform.

GE Extends Strategic Relationship With Australian-based Nanosonics to Expand Healthcare Innovation Globally

June 24, 2012 8:18 pm | by The Associated Press | News | Comments

SYDNEY--(BUSINESS WIRE)--Jun 24, 2012-- GE [NYSE: GE] today announced a $7.5 million investment in Australian-based Nanosonics Limited [ASX: NAN] - a leader in the development of innovative technology for infection control - to further develop and distribute Trophon EPR, an ultrasound...

GE Extends Strategic Relationship With Australian-based Nanosonics to Expand Healthcare Innovation Globally

June 24, 2012 4:45 pm | by The Associated Press | News | Comments

GE Extends Strategic Relationship With Australian-based Nanosonics to Expand Healthcare Innovation Globally SYDNEY--(BUSINESS WIRE)--Jun 24, 2012-- GE [NYSE: GE] today announced a $7.5 million investment in Australian-based Nanosonics Limited [ASX: NAN] - a leader in the development of...

OSC Surveillance Guidance Proves FDA Wrongdoing: Lawyers for Whistleblowers

June 22, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

A new memorandum issued by the U.S. Office of Special Counsel (OSC) instructing federal agencies to ensure their electronic surveillance policies and practices do not deter whistleblowing “confirms” the FDA broke the law when it allegedly monitored the personal emails of...

MDUFA Passes Final House Vote With Few Changes to Device Provisions

June 22, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The House Wednesday overwhelmingly approved reauthorizing the Medical Device User Fee Act (MDUFA), sending it on to the Senate with a voice vote.

Nidek Medical Products Mark 5 Nuvo, Nuvo 8, and Nuvo Lite Oxygen Concentrators: Class I Recall - Risk of Fire, Loss of Supplemental Oxygen

June 21, 2012 12:30 pm | by U.S. Food & Drug Administration | News | Comments

A capacitor failure may result in a fire hazard and loss of supplemental oxygen, which can lead to serious adverse health consequences, including death.

Class I Medical Device Recall: Nidek Medical Products, Inc., Mark 5 Nuvo, Nuvo 8 and Nuvo Lite Oxygen Concentrators

June 21, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: Capacitor failure may result in a fire hazard and loss of supplemental oxygen. These products may cause serious adverse health consequences, including death.

Summary Information for: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems

June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Access® Hybritech p2PSA on the Access Immunoassay Systems (P090026).

Consumer Information on: Access & #xae; Hybritech p2PSA on the Access Immunoassay Systems - P090026

June 20, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

The Access® Hybritech p2PSA on the Access Immunoassay Systems is an automated laboratory test that measures how much [-2]proPSA a man has in his blood.

Integra LifeSciences Announces Launch of the Integra IPP-ON PIP Fusion System for Extremity Reconstruction

June 20, 2012 8:18 am | News | Comments

Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced the introduction of Integra(R) IPP-ON(R) PIP Fusion System, for fixation of proximal interphalangeal (PIP) joint arthrodesis.

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