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Alere rapid flu test receives CLIA waiver from FDA

January 23, 2012 5:07 am | News | Comments

Waltham, Massachusetts – Alere Inc., a global leader in enabling individuals to take charge of their health at home through the merger of rapid diagnostics and health management, received confirmation that The U.S. Food and Drug Administration (FDA) has cleared the Alere™ Influenza A&B Test...

Crux Biomedical's IVC Filter Receives CE Mark Approval

January 23, 2012 5:05 am | News | Comments

MENLO PARK, Calif. /PRNewswire/ -- Crux Biomedical announced it has received CE mark approval for their revolutionary inferior vena cava filter (IVCF) with bi-directional retrieval (BDR). Vena cava filters are designed to trap blood clots that can lead to a potentially fatal pulmonary embolism (PE). 

A-STAR, GE Global Research Join Forces to Develop Integrated Advanced Medical Imaging Technologies

January 23, 2012 5:02 am | News | Comments

Singapore - (ACN Newswire) - GE Global Research, the central technology development arm for GE Healthcare and all of GE's businesses, has signed a Memorandum of Understanding (MOU) with Singapore's Agency of Science, Technology and Research (A*STAR).

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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.

Tysabri (natalizumab): Drug Safety Communication - New Risk Factor for Progressive Multifocal Leukoencephalopathy (PML)

January 20, 2012 1:30 pm | by U.S. Food & Drug Administration | News | Comments

The risks and benefits of continuing treatment with Tysabri should be carefully considered in patients who are found to be anti-JCV antibody positive and have one or more of the other known risk factors for PML.

Perfect Image Solutions Topical Hair Regrowth Products: Recall - Unapproved Drugs, Risk of Health Hazards

January 20, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments

Systemic absorption of topically administered Minoxidil could cause low blood pressure, heart palpitations and associated cardiac symptoms.

Vagifresh Ball, Vagifresh Gel, Female One: Recall - Undeclared Drug Ingredient, Bacterial Contamination

January 20, 2012 9:30 am | by U.S. Food & Drug Administration | News | Comments

Possibility of an adverse reaction or unknown drug-drug interaction.

Saint Thomas Heart Opens New Ventricular Assist Device Center; One of Only 33 Dedicated Centers in United States

January 20, 2012 5:23 am | News | Comments

NASHVILLE, Tenn.--(BUSINESS WIRE)--Saint Thomas Hospital, a member of Saint Thomas Health and a national leader in cardiac care, announced today the opening of the Saint Thomas Heart Ventricular Assist Device (VAD) Center at an invitation only event at LP Field.

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KFx Announces the Upcoming Publications of Results on Its APPIANFx Femoral Implant for ACL Reconstruction

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

SAN DIEGO--(BUSINESS WIRE)--KFx announces the upcoming publications of results on its APPIANFx Femoral Implant for ACL Reconstruction at the upcoming ORS (Orthopedic Research Society 2012 Meeting) meeting February 4th-7th in San Francisco, CA. “We believe this is a first...

Covidien Provides Update on Voluntary Recall of BIS Bilateral Sensors

January 20, 2012 5:10 am | News | Comments

BOULDER, Colo.--(BUSINESS WIRE)--On November 8, 2011, Covidien initiated a voluntary recall of certain lots of its BISâ„¢ Bilateral Sensors, due to a modification which inadvertently reversed the reference and left eye electrode. This modification could potentially cause a change...

European Coronary Stent Market to Decline to $490 Million by 2016, Despite Growth in Number of Procedures

January 20, 2012 5:06 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, while the number of coronary stenting procedures performed will show steady growth, stent selling prices will decline significantly...

Gore Receives First FDA Approval for Endovascular Repair of Traumatic Aortic Transections

January 20, 2012 5:01 am | News | Comments

FLAGSTAFF, Ariz.--(BUSINESS WIRE)--W. L. Gore & Associates, Inc. (Gore) announced that the US Food and Drug Administration (FDA) has approved the Conformable GORE® TAG® Thoracic Endoprosthesis for endovascular repair of isolated lesions of the descending thoracic aorta...

U.S. Oncology Research Enrolls More Than 50,000 Patients Into Clinical Trials

January 20, 2012 4:46 am | News | Comments

THE WOODLANDS, Texas--(BUSINESS WIRE)-- US Oncology Research, supported by McKesson Specialty Health, announced today that it has surpassed the 50,000 milestone for patients enrolled in its clinical trials program. One of the largest community-based research networks in the world...

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Indiana's medical device industry is fifth largest in U.S. generating $10 billion annually

January 20, 2012 4:41 am | News | Comments

INDIANAPOLIS, Ind., - According to a report released today by BioCrossroads, the medical devices industry is one of Indiana's most valuable economic assets employing over 20,000 people, and generating more than $10 billion of annual economic output. The first of its kind report...

Consumer Information on: GORE TAG Thoracic Endoprosthesis - P040043/S040

January 19, 2012 5:31 am | by U.S. Food & Drug Administration | News | Comments

The GORE TAG Thoracic Endoprosthesis is an artificial endovascular stent graft and is used to treat isolated lesions, excluding dissections, of the descending thoracic aorta during endovascular repair. Some of the complex isolated lesions include...

Summary Information for: GORE TAG Thoracic Endoprosthesis

January 19, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments

Labeling, Approval Order, and Summary of Safety and Effectiveness for GORE TAG Thoracic Endoprosthesis (P040043S040).

Biotectix Announces First Human Implants of BT DOT Coated Electrodes

January 19, 2012 5:18 am | News | Comments

ANN ARBOR, Mich.--(BUSINESS WIRE)--Biotectix, LLC, an Allied Minds, Inc. subsidiary, is pleased to announce the first-in-human (FIH) use of an electrostimulation device incorporating its BT DOT conductive polymer coating technology. Last month, patients were surgically implanted...

Independent Data Safety Monitoring Board Recommends St. Jude Medical's FAME II Clinical Trial Stop Enrollment Following Positive Interim Analysis

January 19, 2012 5:13 am | News | Comments

ST. PAUL, Minn.--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when...

Toshiba's Aquilion ONE CT Facilitates Faster, Accurate Neuro Imaging at Buffalo General Medical Center Emergency Department

January 19, 2012 5:02 am | News | Comments

TUSTIN, Calif.--(BUSINESS WIRE)--Based on proven success at Millard Fillmore Gates Circle Hospital triaging stroke patients, Kaleida Health installed a second Aquilion ONE from Toshiba America Medical Systems, Inc., at Buffalo General Medical Center in Buffalo, N.Y.

Slovenia's 1st Total Artificial Heart Patient Discharged from UMC Ljubljana Using the Freedom Portable Driver

January 19, 2012 4:55 am | News | Comments

TUCSON, Ariz. – SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that on Dec. 29, 2011, University Medical Center (UMC) Ljubljana discharged Slovenia's first Total Artificial Heart patient, 61-year-old...

Interstate Specialty Products Receives ISO 13485 Certification

January 19, 2012 4:51 am | News | Comments

Sutton, MA – Interstate Specialty Products, Inc., a manufacturer of high performance custom gaskets and provider of custom die-cutting services, recently received ISO 13485 certification for their quality management system. ISO 13485 is an international standard thatspecifies requirements...

Patients Report Controversial Multiple Sclerosis Treatment Improves Their Lives: Presented at ISET 2012

January 18, 2012 5:55 am | News | Comments

MIAMI BEACH, Fla.--(BUSINESS WIRE)--Although using angioplasty to treat multiple sclerosis (MS) is highly controversial, sufferers often insist it helps – in some cases dramatically, such as allowing them to walk without a cane. Patients with less severe MS also reported additional quality...

Fujifilm Holdings Commences Tender Offer to Acquire SonoSite, Inc.

January 18, 2012 5:48 am | News | Comments

TOKYO & NEW YORK--(BUSINESS WIRE)--FUJIFILM Holdings Corporation (TSE: 4901, hereinafter: Fujifilm), a diversified technology company that operates in healthcare, highly functional materials, and document solutions, announced today the commencement of a tender offer...

InVivo Therapeutics, Geisinger Health System to Conduct Preclinical Study of Injectable Scaffold for Peripheral Nerve Injury For FDA Submission

January 18, 2012 5:45 am | News | Comments

CAMBRIDGE, Mass. & DANVILLE, Pa.--(BUSINESS WIRE)--InVivo Therapeutics Holdings Corp., a developer of groundbreaking technologies for the treatment of spinal cord injuries (SCI), and Geisinger Health System today announced a research collaboration to conduct a preclinical study...

SANUWAVE Issued U.S. Patent for a New Method to Produce Acoustic Shock Waves Utilizing Pressurized Fluid

January 18, 2012 5:43 am | News | Comments

ALPHARETTA, Ga.--(BUSINESS WIRE)--SANUWAVE Health, Inc. today announced that the U.S. Patent and Trademark Office (USPTO) has issued the Company patent number 8,092,401, titled “Method and Apparatus for Producing Shock Waves for Medical Applications.”

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