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Lilly Statement on Affordable Care Act Ruling by Supreme Court

June 28, 2012 11:21 am | 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,...

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 | News | Comments

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

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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...

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...

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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 | 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 | 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 | 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 | 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.

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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 | 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 | 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 | 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 | 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.

Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis

June 20, 2012 5:30 am | News | Comments

This draft guidance document was developed as a special control guidance to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed, is intended to provide access to a..

Helping Start-Ups Avoid Slow-Downs

June 19, 2012 11:07 am | Blogs | Comments

BSI Group America, Inc. identifies the 7 Most Common “Rookie” Mistakes Medical Device Companies Make When Preparing for a European Product Launch

Medical visualization technologies: 3D Endoscope

June 19, 2012 10:13 am | Blogs | Comments

Taking a deeper dive into some of the specific technologies that have improved medical visualization and as a follow up to my post titled Medical Visualization Technologies, here is an overview of how the 3D endoscope in particular has promoted these advances.

PositiveID Corporation Wins Gold at Connected World Value Chain Awards for Its iglucose Mobile Health Solution for Diabetes Management

June 19, 2012 6:50 am | News | Comments

PositiveID Corporation announced it has won the Gold award for its iglucose mobile health solution for diabetes management at Connected World magazine's Value Chain Awards in the Home Health category.

Penumbra Inc. Launches the New MAX System Reperfusion Catheters for Acute Ischemic Stroke Patients

June 19, 2012 6:03 am | News | Comments

The Penumbra System® family of aspiration thrombectomy devices now includes the MAX System of Reperfusion Catheters for removal of clots in patients experiencing acute ischemic stroke. The MAX System neuro-interventional devices offer a fast, simplified...

Consumer Information on: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) - P110010/S001

June 18, 2012 10:30 am | News | Comments

The PROMUS Element stent is a metal stent with the drug everolimus contained in a thin coating on the stent?s surface. The PROMUS Element stent is mounted on a folded balloon attached to a catheter delivery system for placement into a coronary artery...

Summary Information for: PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire)

June 18, 2012 10:30 am | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P110010S001).

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