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New White Paper Discusses the Precision and Efficiency the BoneScalpel Ultrasonic Bone Cutting System Offers Neurosurgical and Orthopaedic Surgeons

April 20, 2012 5:43 am | News | Comments

According to the American Association of Neurological Surgeons (AANS), over 320,000 spinal procedures out of some 550,000, or 58%, require some type of bone cutting.1 Traditionally, bone removal in spinal surgeries has been performed by hand instruments or cutting burrs...

Catheter Connections Introduces the DualCap System: Helping Clinicians Keep IV Lines Disinfected and Protected from Deadly Contamination

April 20, 2012 5:38 am | News | Comments

The U.S. healthcare system suffers from a glaring, persistent need to protect patients from unsafe IV infusions. Contaminated IV lines result in unnecessary patient injuries and death, and cost hospitals billions of dollars annually. To address this crisis, Catheter Connections...

Numera Acquires BlueLibris and Expands Offerings Into Telecare

April 20, 2012 5:36 am | News | Comments

Numera announced today the acquisition of BlueLibris, LLC, a leader in personal health monitoring and safety technologies. The acquisition adds a novel, mobile telecare platform to Numera's existing telehealth products, social engagement solutions, and professional services portfolio.

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Circuite Provides Updated Clinical Data on Synergy Miniature Ventricular Support System in Multiple Presentations at ISHLT Annual Meeting

April 20, 2012 5:34 am | News | Comments

CircuLite®, Inc. today announced that updated clinical data related to the Synergy® miniature ventricular support system was presented in two oral presentations and one poster session at the International Society for Heart and Lung Transplantation's 32nd Annual Meeting and Scientific Sessions...

Sequana Medical's ALFApump® System Proves to Be a Safe and Efficacious Breakthrough Technology in Ascites Management

April 20, 2012 5:32 am | News | Comments

Sequana Medical announced that initial results from the PIONEER Clinical Study of its ALFApump System were presented today at the 47th annual European Association for Study of the Liver Meeting in Barcelona. The data demonstrated that the ALFApump System...

Hospitals, Healthcare Providers to Benefit from New Premier Agreements for Orthopedic Total Joint Implants

April 20, 2012 5:26 am | News | Comments

The Premier healthcare alliance today announced new agreements for orthopedic total joint implants have been awarded to Biomet Orthopedics Inc. of Warsaw, Ind., and Zimmer US Inc. of Warsaw, Ind. The companies join Exactech...

CurveBeam, LLC Receives FDA Approval for pedCAT

April 20, 2012 5:12 am | News | Comments

Diagnostic imaging innovator CurveBeam announced today that it has received 510(k) approval from the U.S. Food and Drug Administration (FDA) for pedCAT, its weight bearing, in-office 3D foot and ankle scanner. pedCAT utilizes Cone Beam Computed Tomography...

IBN Discovers Human Neural Stem Cells with Tumor Targeting Ability - A Promising Discovery for Breast Cancer Therapy

April 20, 2012 5:05 am | News | Comments

Could engineered human stem cells hold the key to cancer survival? Scientists at the Institute of Bioengineering and Nanotechnology (IBN), the world's first bioengineering and nanotechnology research institute, have discovered that neural stem cells...

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Devicor launches new tetherless vacuum-assisted biopsy system

April 19, 2012 9:16 am | News | Comments

Devicor® Medical Products, Inc. (Devicor), announced today the commercial launch of the Mammotome® elite Biopsy System, the only tetherless single insertion, multiple sample, vacuum-assisted biopsy (VAB) device featuring proprietary TruVac™ vacuum technology.

Elekta Announces First Patients Treated with Major Breakthrough in Cancer Therapy

April 19, 2012 5:20 am | News | Comments

Using Agilityâ„¢, Elekta's latest MLC innovation, patients at St. James's University Hospital were the first in the world to benefit from this modern advancement in the treatment of cancer. With twice the number of leaves typical of many standard MLCs...

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).

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...

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...

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