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GE Healthcare Receives Approval for Its Own Manufacturing of Optison

November 18, 2013 9:00 am | by Business Wire | Comments

GE Healthcare announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to allow the company to manufacture Optison™ (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) in-house. Optison is...


Philips Honored With Prestigious Respiratory Industry Excellence Award At AARC International Respiratory Congress

November 18, 2013 9:00 am | by PR Newswire | Comments

Royal Philips has announced it has earned the prominent Zenith Award for a 15th time from the American Association for Respiratory Care (AARC). Philips is one of just six companies to receive the award that honors excellence in products and...


Cephasonics Releases New cQuest Dragonfly Family of Ultra-Compact Ultrasound Systems

November 18, 2013 9:00 am | by PR Newswire | Comments

Cephasonics, a technology-innovation leader with a game-changing embedded-ultrasound platform, today announced the introduction of the cQuest Dragonfly™ family of modular 32- or 64-channel, high performance systems engineered for size and...


Salix Announces Approval of Additional Injection Techniques for Deflux®

November 18, 2013 7:00 am | by Business Wire | Comments

Salix Pharmaceuticals, Ltd. today announced that The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has approved the Deflux ® premarket approval (PMA) supplement, which requested approval of labeling...


Paragonix Technologies Inc., Announces Filing of a Second 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for the Paragonix Sherpa™ Cardiac Transport System

November 18, 2013 6:00 am | by Business Wire | Comments

Paragonix Technologies, Inc. today announced that it has successfully completed filing of a second Pre-Marketing Notification Application (510(k)) with the US Food and Drug Administration (FDA) for its Paragonix Sherpa Pak™ Cardiac Transport...


New Diagnostic and Surgical Innovations and Data Management Solutions from ZEISS

November 16, 2013 10:22 pm | by Business Wire | Comments

US Introduction of FORUM Glaucoma Workplace from ZEISS ZEISS announces the US release of a new glaucoma diagnostic and management software application, FORUM Glaucoma Workplace, at the 2013 Annual Meeting of the American Academy of Ophthalmology...


FDA Issues Stern Warning on Medtronic Devices

November 16, 2013 7:19 pm | by David Koenig - AP Business Writer | Comments

Federal health officials say that defects in some Medtronic devices used in heart procedures are severe enough that they could cause serious injury or death. The warning covers about 15,000 recalled guidewires, which are inserted through an artery...


InVivo surges 56% on news of impending U.S. trial, search for strategic partnerships

November 16, 2013 1:41 am | by Mass Device | Comments

Massachusetts-based InVivo Therapeutics saw a major surge on Wall Street on Friday after the market reacted to news that it will soon begin enrolling patients in a U.S. clinical trial of its 1st investigational product, diverting development efforts...


NIH Study Finds Patients at High-Risk for Developing Neovascular Age-Related Macular Degeneration Benefit from ForeseeHome Monitoring for Early Detection of CNV

November 16, 2013 12:01 am | by The Associated Press | Comments

The results of the Home Monitoring of the Eye (HOME) study, conducted in Age-Related Eye Disease Study 2 (AREDS2) clinical centers, executed by the EMMES Corporation and sponsored by Notal Vision Ltd. Tel Aviv, Israel, have been accepted for...


Study: Donor Age Not a Factor in Most Corneal Transplants

November 15, 2013 5:19 pm | by NIH/National Eye Institute | Comments

Ten years after a transplant, a cornea from a 71-year-old donor is likely to remain as healthy as a cornea from a donor half that age, according to a study funded by the National Institutes of Health. Corneas from donors over age 71 perform...


Intelliject, Inc. wins prestigious medication safety award

November 15, 2013 4:21 pm | by PR Newswire | Comments

The Institute for Safe Medication Practices (ISMP) has announced that this year's George DiDomizio Industry Award is being presented to Intelliject, Inc. for pioneering advances in drug/device combination products with the Auvi-Q epinephrine...


New Factors Reshaping Medical Education Programs in the Life Sciences Industries

November 15, 2013 3:50 pm | by PR Newswire | Comments

Medical Education groups are often being transformed by regulatory and budget pressures, making it increasingly difficult to effectively educate healthcare practitioners on the safe and effective use of products. With the pressure to reduce budgets...


PLC Systems reports revenue surge in 3rd quarter

November 15, 2013 1:39 pm | by Mass Device | Comments

PLC Systems is cutting down on its losses, thanks in part to strong revenues during the 3rd quarter. PLC Systems posted losses of $609,000, or -1¢ per share, on sales of $348,000 for the 3 months ended Sept. 30, narrowing losses by 81% and...

Lumenis wins U.S. & Japanese clearance for retinal laser treatment

November 15, 2013 1:28 pm | by Mass Device | Comments

Lumenis Ltd. announced today regulatory wins in the U.S. and Japan for its Array LaserLink pattern scanning device for multi-spot laser photocoagulation for use during retinal surgery. The Array LaserLink, which turns an "examination slit lamp"...


University of Minnesota to Unveil New Medical Simulation Technologies at LifeScience Alley Conference Next Week

November 15, 2013 1:17 pm | by Business Wire | Comments

LifeScience Alley announced today that the University of Minnesota Medical School's SIMPortal, the Interactive Visualization Lab and the Medical Devices Center will publicly unveil "The Anatomy of Success", a multi-disciplinary academia-industry...



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