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BD Veritor System for Flu A+B Featuring Alverix Technology Receives Regulatory Approval in Japan

February 9, 2012 5:02 am | News | Comments

SAN JOSE, Calif.--(BUSINESS WIRE)--Alverix announced today that BD (Becton, Dickinson and Company) has received approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the BD Veritorâ„¢ System Flu A+B Test. The BD Veritor System was developed...

Survey: Medical Device Industry Reports Healthy Sales, Ongoing BRIC Interest

February 9, 2012 4:36 am | News | Comments

AUSTIN, Tex.-Despite a tepid economy, medical device manufacturers' international sales growth rates continued to outpace their domestic business in 2011, demonstrating the increasingly global nature of the industry. According to a new survey of more than 2,600 medical device industry...

Survey: Smaller Medical Device Firms Plan to Increase Prices and Lower Costs to Offset US Excise Tax

February 9, 2012 4:34 am | News | Comments

AUSTIN, Tex.-According to a new industry survey conducted by global consultancy Emergo Group, medical device manufacturers plan to increase prices for their products in order to offset the effects of a proposed 2.3% excise tax on all device sales in the US set to take effect in 2013.

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Proton Pump Inhibitors (PPIs) - Drug Safety Communication: Clostridum Difficile-Associated Diarrhea (CDAD) Can be Associated With Stomach Acid Drugs

February 8, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Symptoms may include watery stool, abdominal pain, and fever. Patients may go on to develop more serious intestinal conditions.

Meeting Materials for the Neurological Devices Panel meeting to be held on 2/10/12

February 8, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

The Neurological Devices Panel reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including clinical and molecular genetics ...

GAO Investigation Finds Lack of Price Transparency in Medical Device Marketplace May Drive up Costs for Hospitals and Medicare

February 6, 2012 5:47 am | News | Comments

Washington, DC – The Healthcare Supply Chain Association (HSCA) today applauded the U.S. Government Accountability Office for its new report, Lack of Price Transparency May Hamper Hospitals' Ability to Be Prudent Purchasers of Implantable Medical Devices, which found that...

Healthy People Co. Dietary Supplements: Recall - Undeclared Drug Ingredient

February 6, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

Recalled products pose significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

Gris-PEG (griseofulvin ultramicrosize): Health Advisory - Risk of Product Mix-Up

February 3, 2012 12:31 pm | by U.S. Food & Drug Administration | News | Comments

During packaging and labeling, tablets from one product type may have carried over into packaging of another product.

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Acetylcysteine Solution, USP (Roxane Laboratories, Inc.): Recall - Visible Glass Particle

February 3, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Use of an inhaled product with glass particles has the potential to cause choking which could be life-threatening.

Summary Information for: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator

February 2, 2012 11:31 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator (P110016).

Consumer Information on: Therapy Cool Path Duo? Ablation Catheter, Safire BLU Duo? Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator - P110016

February 2, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

The Therapy Cool Path Duo? Ablation Catheter or the Safire BLU Duo? Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial..

Extended Sunshine Act Deadline Provides Extra Time for Pharma, Biotech and Device Companies to Track and Report Physician Payments

February 1, 2012 5:56 am | News | Comments

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--As the industry awaits the release of the delayed Sunshine Act guidelines, pharmaceutical and medical device companies are benefiting from the extra time by reviewing current physician payment reporting structures...

FDA and industry reach agreement in principle on medical device user fees

February 1, 2012 5:12 am | News | Comments

The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees...

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Lo/Ovral-28 (Norgestrel/EthinylEstradiol) Tablets: Recall - Possibility of Inexact Tablet Counts or Out of Sequence Tablets

February 1, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Oral contraceptive daily regimen may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans

January 31, 2012 8:30 am | by U.S. Food & Drug Administration | News | Comments

Consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia).

Treanda (bendamustine HCL): Recall - Particulate Matter in Vial

January 30, 2012 4:30 am | by U.S. Food & Drug Administration | News | Comments

Potential adverse events after intravenous administration of solutions containing particulates may include emboli and result in disruption of blood flow, causing tissue/organ damage.

CDRH: Priorities This Year Include Product Lifecycle, Helping Innovation

January 27, 2012 1:31 pm | by U.S. Food & Drug Administration | News | Comments

CDRH’s 2012 priorities include a strong focus on innovation and the device approval process, a strategic report shows.

Congressional Democrats Call for Hearings on Hazardous Medical Devices

January 27, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

House Democrats are urging the Committee on Energy and Commerce to hold hearings on whether the FDA and device industry are doing all they can to protect consumers from unsafe products.

Consumer Information on: M-Vu Algorithm Engine - P100005

January 27, 2012 11:31 am | by U.S. Food & Drug Administration | News | Comments

The M-Vu Algorithm Engine is a software application designed to process digitized film images of the breast. The software analyzes the images and marks suspicious areas consistent with breast cancer for review by a radiologist. The results are displayed o

Summary Information for: M-Vu Algorithm Engine

January 27, 2012 11:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for M-Vu Algorithm Engine (P100005).

Summary Information for: MelaFind & #xae;

January 25, 2012 7:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for MelaFind® (P090012).

Suspension Orthopaedics Gets FDA Clearance for Surgical System

January 25, 2012 5:23 am | News | Comments

ARNOLD, MD - Suspension Orthopaedic Solutions announced it has received FDA 510(k) clearance for two new products - its Distal Clavicle Fracture Fixation Systemâ„¢ and a new plate designed to address repair of mid-shaft clavicle fractures. The new Distal Clavicle Fracture Fixation System features...

Consumer Information on: ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Assay and ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA & #xae; Centaur and ...

January 24, 2012 3:31 am | by U.S. Food & Drug Administration | News | Comments

ADVIA Centaur Anti-HBs2 (aHBs2) assay is a laboratory test used to detect antibodies associated with hepatitis B virus (HBV) infection.

Summary Information for: ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Assay and ADVIA & #xae; Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA & #xae; Centaur and ...

January 24, 2012 3:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for ADVIA® Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA® Centaur and ADVIA® Centaur XP Systems (P100039).

Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes (New Memos Available).

January 23, 2012 3:31 am | by U.S. Food & Drug Administration | News | Comments

A 180-day supplement is a request for a significant change in components, materials, design, specification, software, color additive, and labeling to an approved premarket application or premarket report.

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