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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Cefepime:Label Change- Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney ImpairmentJune 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.
Ultrasonix Medical Corporation has received approval from the US Food and Drug Administration for its SonixGPS technology for Vascular Access procedures.
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...
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...
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 ConditionsJune 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, 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 GloballyJune 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 GloballyJune 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...
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...
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 OxygenJune 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 ConcentratorsJune 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.
Labeling, Approval Order, and Summary of Safety and Effectiveness for Access® Hybritech p2PSA on the Access Immunoassay Systems (P090026).
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 ReconstructionJune 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 HemodialysisJune 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..
BSI Group America, Inc. identifies the 7 Most Common “Rookie” Mistakes Medical Device Companies Make When Preparing for a European Product Launch
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 ManagementJune 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.
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/S001June 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).