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Other?Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial Contamination

April 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Exposure to contaminated product may lead to serious infections.

Markey Calls for Stronger Medical Device Protections in FDA User Fee Act Legislative Package

April 18, 2012 9:52 am | News | Comments

WASHINGTON, D.C. - Congressman Edward J. Markey (D-Mass.), a senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), issued the following statement after the Subcommittee on Health hearing on the discussion...

Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume

April 18, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.

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Tangent Medical To Unveil Innovative Closed IV Catheter System to Address IV Therapy Challenges

April 18, 2012 5:14 am | News | Comments

Tangent Medical, an innovator in IV therapy products, today announced its participation (Booth # 329) at the 2012 INS Annual Convention & Industrial Exhibition on April 30 - May 2, 2012 at the Rio Hotel in Las Vegas. The NovaCathâ„¢ Secure IV Catheter System...

Depuy Spine Launches New Transfacet Pedicular Fixation System for Lumbar Spinal Fusion Surgery

April 17, 2012 11:53 am | News | Comments

DePuy Spine, Inc. today announced the launch of the VIPER® F2 Transfacet Pedicular System (VIPER F2), a transfacet pedicular screw and polyaxial ring system designed to provide stabilization and fixation during degenerative lumbar spinal fusion procedures.

New Stryker Device Offers Hospitals Environmental and Bottom-line Benefits

April 17, 2012 11:48 am | News | Comments

Stryker's Sustainability Solutions division, a leader in medical device reprocessing, today introduced Restep®, the company's pioneering deep vein thrombosis (DVT) solution. Restep addresses a critical need in the market for comprehensive device solutions that deliver fiscal...

Consumer Information on: ARCHITECT HBsAg - P110029

April 17, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

These reagents are used with the Abbott ARCHITECT Instrument System to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV.

Summary Information for: ARCHITECT HBsAg

April 17, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for ARCHITECT HBsAg (P110029).

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New radiation therapy reduces treatment of gynecologic cancers from 5 weeks to 3 days

April 17, 2012 5:52 am | News | Comments

About 71,500 women in the United States are diagnosed with a gynecologic cancer every year, according to the Centers for Disease Control. Researchers from University Hospitals Case Medical Center have developed a more effective way to treat gynecologic cancers...

Ultra-Sensitive Electrical Biosensor Unlocks Potential for Instant Diagnostic Devices

April 17, 2012 5:50 am | News | Comments

(Santa Barbara, Calif.) A new quantum mechanical-based biosensor designed by a team at University of California, Santa Barbara offers tremendous potential for detecting biomolecules at ultra-low concentrations, from instant point-of-care disease diagnostics, to detection...

New research suggests PIP implant failures significantly higher than previously thought

April 17, 2012 5:48 am | News | Comments

London - New research published in the Journal of Plastic, Reconstructive and Aesthetic Surgery suggests that the failure rate of silicone breast implants manufactured by Poly Implant Prosthèse (PIP) could be as high as 33.8%.

OmniGuide Launches Next Generation System for CO2 Laser Surgery

April 17, 2012 5:23 am | News | Comments

CAMBRIDGE, Mass. – OmniGuide Inc., a Cambridge, Massachusetts medical device company specializing in advanced energy surgical instruments, announces the launch of their new FELS-25A Intelliguide, the next generation laser system for minimally invasive CO2 laser surgery.

Isansys Lifecare Achieves CE Mark for LifeTouch Patient Surveillance System – World's First Cloud-Ready Medical Device

April 17, 2012 5:15 am | News | Comments

Abingdon, United Kingdom – Isansys Lifecare Limited, the provider of complete real-time physiological patient data services and systems, today announces that it has achieved CE certification for its LifeTouch Patient Surveillance System, comprising the LifeTouch HRV011...

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Medical Visualization Technologies

April 17, 2012 12:00 am | by Dr. Euan Morrison | Blogs | Comments

Over the past few decades, we have seen significant advances in medical visualization technologies with the emergence and widespread use of sophisticated techniques such as magnetic resonant imaging (MRI) and X-ray computed tomography (CT scanning).

Less Invasive Liver Surgery Technique Easier on Patient, Equally as Safe as Traditional Surgery Method, Study Says

April 16, 2012 9:30 am | News | Comments

(Washington, DC) - A new study published in the Journal of the American College of Surgeons shows that less invasive laparoscopic-assisted liver surgery performed at MedStar Georgetown University Hospital is easier on the patient and is just as safe and effective as traditional liver surgery...

Harry and David Issues Allergy Alert on Undeclared Peanuts in Harry & David Premium Kansas City Style Barbeque Almonds

April 13, 2012 8:31 pm | by U.S. Food & Drug Administration | News | Comments

Harry and David, is voluntarily recalling approximately 205 2 oz. bags labeled Harry & David Premium Kansas City Style Barbeque almonds, because the bags may contain peanuts. Peanuts are not declared as ingredients, but the label includes the statement "May contain trace amounts of...

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product

April 13, 2012 8:30 pm | by U.S. Food & Drug Administration | News | Comments

• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a...

Breast Cancer Ultrasound Device Gets Favorable Panel Recommendation

April 13, 2012 2:32 pm | by U.S. Food & Drug Administration | News | Comments

An FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose.

U.S. Should Bring Developing Nations on Board to Tackle Import Problems: Report

April 13, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report. The recommendation is one...

Hospira Infusion Pumps Ranked Top Devices in New KLAS Smart Pumps 2012 Report

April 13, 2012 12:21 pm | News | Comments

LAKE FOREST, Ill. -- Hospira, Inc., the world's leading provider of injectable drugs and infusion technologies, today announced its Symbiq™ and LifeCare™ PCA infusion pumps have been ranked as the top devices in their categories in the KLAS report, Smart Pumps 2012...

Medtronic Initiates Landmark U.S. Drug-Eluting Balloon Study

April 13, 2012 7:19 am | News | Comments

MINNEAPOLIS –– Expanding its commitment to developing innovative treatments for cardiovascular disease and the evidence to support their adoption, Medtronic, Inc. announced today the start of the Medtronic IN.PACT SFA II study, the company’s first...

Engineering the Dynamics of Pulsating Blood Flow

April 13, 2012 6:12 am | by Satya Karri, Ph.D. | Articles | Comments

With cardiovascular diseases as the leading cause of death worldwide, device manufacturers are under immense pressure to produce products to address these health concerns. However, prior to launching such devices, the technologies need to be properly tested to ensure success. This article looks at setting up a system to simulate cardiac flow for testing these medical devices.

InVivo Therapeutics Expects to Commence Human Study after Meeting on IDE Filing for Biopolymer Scaffolding to Treat Spinal Cord Injuries

April 13, 2012 5:36 am | News | Comments

CAMBRIDGE, Mass.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp., a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), announced today that it held a meeting with the U.S. Food and Drug Administration (“FDA”) in which...

Meridian Bioscience Awarded New Agreement with Premier Healthcare Alliance for Molecular Diagnostic Tests and Instruments for C. difficile and Group B Streptococcus

April 13, 2012 5:34 am | News | Comments

CINCINNATI--(BUSINESS WIRE)--Meridian Bioscience, Inc. today announced it has signed a new group purchasing agreement with the Premier healthcare alliance to offer illumigene® C. difficile and illumigene Group B Streptococcus to its members at specially negotiated pricing.

Geomagic Acquires Sensable 3D Design and Haptics Businesses

April 13, 2012 5:32 am | News | Comments

MORRISVILLE, N.C.--(BUSINESS WIRE)--Geomagic®, the leading provider of 3D software for capturing, creating and inspecting digital models of physical objects, today completed an acquisition of Sensable Technology Inc.’s 3D design and haptics businesses. Sensable...

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