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Argatroban Injection 50 mg/50 mL (1 mg/mL): Recall - Potential for Visible Particulates

March 23, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Risk of embolization/infarction to organs and potential organ complications.

CDRH Learn (New Module - ISO 13485:2003 Voluntary Audit Report Submission Pilot Program)

March 23, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments

This presentation explains FDA's new voluntary audit report submission pilot program, which is based on ISO 13485, an international standard utilized in the medical-device sector in many places around the world.

Itamar-Medical Launches Next-Generation, Cardiovascular Health Assessment Platform

March 22, 2012 11:41 am | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Itamar-Medical, the leading provider of diagnostic devices for cardiovascular disease and sleep apnea based on its proprietary PAT® signal technology, will unveil its cardiovascular healthcare assessment platform, EndoPAT-MF, at the upcoming...

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Meridian Companies Announces 'LipoLaser' Lawsuit Ends

March 22, 2012 11:39 am | News | Comments

VANCOUVER, British Columbia--(BUSINESS WIRE)--Meridian Companies (“Meridian”), a medical device company focused on the manufacturing and distribution of wellness and medical devices, is pleased to announce that the lawsuit between Meridian and Erchonia Corporation (Erchonia) has ended.

Fenwal, Applied Science Sign Agreement for HemoFlow 400 Blood Monitor and Mixer in Europe

March 22, 2012 11:37 am | News | Comments

LAKE ZURICH, Ill.--(BUSINESS WIRE)--Fenwal, Inc. announced today it has begun marketing, selling and distributing the HemoFlow 400 blood collection monitor/mixer in Europe under a new agreement with the device's manufacturer, Applied Science, Inc.

NeuroLogica Corporation Receives CE Mark Approval for BodyTom

March 22, 2012 11:35 am | News | Comments

DANVERS, Mass.--(BUSINESS WIRE)--NeuroLogica Corporation announced today it has received CE Mark approval for its most recent product BodyTomâ„¢, a portable, full body, multi-slice CT scanner. CE Mark approval allows BodyTom â„¢ to be sold in the European Union.

Toshiba's Newest Ultrasound Systems Offer Breakthrough Imaging Technologies and Advanced Cardiac Capabilities

March 22, 2012 11:33 am | News | Comments

CHICAGO--(BUSINESS WIRE)--Improving the ability to diagnose cardiac disease with advanced ultrasound imaging, Toshiba America Medical Systems, Inc. will showcase the newest additions to its ultrasound product line, AplioTM 500 and Aplio 300 at this year's American College of Cardiology...

Markey Joined by Victim, Patient Advocate in Call for Closure of Dangerous Medical Device Loophole

March 22, 2012 11:27 am | News | Comments

WASHINGTON, D.C. – Today, with tens of thousands of patients suffering grave health effects as a result of defective medical devices, Congressman Edward J. Markey (D-Mass.) released a comprehensive new report titled “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected...

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US Demand for Implantable Medical Devices to Reach $52 Billion in 2015

March 22, 2012 7:35 am | News | Comments

US demand for implantable medical devices is forecast to increase 7.7 percent annually to $52 billion in 2015, benefiting from technological advances and the development of next generation devices that should increase patient and provider confidence in implant products.

Curetis AG to Present Its Unyvero System for Pneumonia Diagnostics

March 22, 2012 7:28 am | News | Comments

Holzgerlingen, Germany -- Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the presentation of its Unyveroâ„¢ System and the Unyveroâ„¢ P50 Pneumonia Cartridge...

Popularity of Homecare Breathes Life into the Respiratory Devices Market

March 22, 2012 7:26 am | News | Comments

NEW YORK (GBI Research) - The global market for respiratory devices is set to increase due to an increase in the number of patients suffering from sleep disorders and respiratory problems, and the increasing popularity of homecare devices, according to a new report by business intelligence experts GBI Research.

Electronic Medical Records Help Keep Costs Down, Say Struggling Hospitals

March 22, 2012 7:20 am | News | Comments

NEW YORK (GBI Research) - Unhealthy modern lifestyles, ageing populations and struggling national health services will combine to create huge demand for Electronic Medical Records (EMR), according to a new report by medical intelligence company GBI Research.

Markey To Call for Closure of Dangerous Medical Device Loophole

March 22, 2012 7:17 am | News | Comments

WASHINGTON, D.C. – Today, 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), will be joined by a patient, surgeon and health advocate at the release of a new report...

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Prepare for Tough Times in the US, Heart Surgery Device Suppliers are Told

March 22, 2012 7:10 am | News | Comments

NEW YORK (GBI Research) - Cardiovascular surgery device suppliers must prepare for tough times ahead in America, according to a new report by business intelligence expert GBI Research. The new report states that instances of cardiac surgery will fall in the US, which represents the largest national market for this treatment...

Brilliant Blue G: Recall of Unapproved Drug - Ongoing Investigation of Fungal Endophthalmitis Cases

March 19, 2012 6:30 am | by U.S. Food & Drug Administration | News | Comments

Reports of eye infections in patients who were given Brilliant Blue G during eye surgeries.

Devicemakers Planning To Cut Back on R & #38;D to Pay for Excise Tax

March 16, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Nearly half of devicemakers (44 percent) in a recent survey said they would pass the costs of the new medical device excise tax on to their customers.

MDUFA Language Published, Public Meeting Set for March 28

March 16, 2012 2:31 pm | by U.S. Food & Drug Administration | News | Comments

The FDA expects to collect $595 million in device user fees by fiscal 2017, according to the FDA’s outline for the reauthorization of the Medical Device User Fee Act (MDUFA).

Guidance for Industry, Third Parties and Food and Drug Administration Staff - Medical Device ISO 13485:2003 Voluntary Audit Report Submission Pilot Program

March 16, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

This guidance provides information on the implementation of section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Public Law 110-85, which amended section 704(g)(7) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)...

Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detect...

March 16, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

This document was developed to support the reclassification of nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex (MTB-complex) in respiratory specimens from class III into class II. These devices are...

Skin Creams, Soaps and Lotions Marketed as Skin Lighteners and Anti-aging Treatments: May Contain the Toxic Metal, Mercury

March 15, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

Products with this toxic metal have been found in at least seven states, are manufactured abroad and often sold in shops in Latino, Asian, African or Middle Eastern neighborhoods and online.

Public Workshop - Medical Device User Fee Program Public Meeting, March 28, 2012

March 15, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

The purpose of the meeting is to provide an opportunity for stakeholders to present their views on the draft recommendations for the reauthorization of the medical device user fee program. We welcome this opportunity to hear from stakeholders as we...

Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 28, 2012

March 15, 2012 9:31 am | by U.S. Food & Drug Administration | News | Comments

FDA reported that they have concluded negotiations with Industry. On February 17, 2012 they reached agreement with all four industry associations Industry on the final details of the fee structure and minor changes to the draft Commitment Letter and...

Expanded Capabilities in Weaving Medical Textiles for Vascular Grafts

March 15, 2012 5:51 am | Product Releases | Comments

Biomedical Structures LLC (BMS), a developer of biomedical textiles for medical devices and other advanced clinical applications, today announced new capabilities for the high-precision...

UBM Canon's Medical Device Group and Gems Sensors & Controls Announce Online Fundamentals Course for Medical Device Professionals

March 15, 2012 5:45 am | by The Associated Press | News | Comments

UBM Canon's Medical Device Group, the global authority on the MedTech industry, today released a new resource, a fundamentals course, which is available free online to registered users. The topic of this course, sponsored by Gems Sensors & Controls, is "The Fundamentals of Level Sensing:...

Consumer Information on: EverFlex Self-Expanding Peripheral Stent System - P110023

March 14, 2012 7:31 am | by U.S. Food & Drug Administration | News | Comments

The EverFlex Self-Expanding Peripheral Stent System is used to re-open narrowed (stenotic) regions of the superficial femoral and proximal popliteal arteries which supply blood to the legs. It consists of two components, the stent and the delivery...

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