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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...

CN Creative Raises Series a Funding To Develop First Medically Approved Electronic Inhaler Nicotine Replacement Therapy for Smoking Cessation

January 25, 2012 5:17 am | News | Comments

MANCHESTER, UK – CN Creative, Ltd. (CNC), a healthcare company providing innovative and sustainable solutions to reduce smoking and smoking-related illnesses, today announced it has raised a Series A financing round led by Advent Life Sciences. The financing raised £2 million...

Ukraine Fortifies Cancer Management Capabilities with New Elekta Technology

January 25, 2012 5:10 am | News | Comments

KYIV, Ukraine /PRNewswire/ -- The Rinat Akhmetov (Development of Ukraine) Foundation took bold strides in 2011 to advance patient care by acquiring a comprehensive range of cancer management technology to equip the radiotherapy department at Rivne Regional Oncologic Dispensary in Ukraine.

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Invibio's PEEK-OPTIMA Polymer Used in Aesculap's FDA 510k Cleared EnduRo Rotational Knee System

January 25, 2012 5:01 am | News | Comments

Thornton Cleveleys, UK -- Invibio® Biomaterial Solutions, the market leader in providing PEEK-based biomaterial solutions to medical device manufacturers around the world, announced today that its PEEK-OPTIMA® Carbon Fibre Reinforced (CFR) polymer is utilized in Aesculap's FDA...

Atlanta Medical Center Selects RF Detection Technology for the Prevention of Retained Surgical Items

January 25, 2012 4:57 am | News | Comments

BELLEVUE, Wash.--(BUSINESS WIRE)--RF Surgical Systems, Inc., the market leader in retained surgical item (RSI) detection, today announced that Atlanta Medical Center, a Level 1 Trauma Center based in Atlanta, Ga., has selected the RF Assureâ„¢ Detection System for use...

PMD Healthcare Launches Spiro PD—The First Personal Spirometer to Monitor Lung Function

January 24, 2012 5:26 am | News | Comments

ALLENTOWN, PENNSYLVANIA -- PMD Healthcare Inc., announced today the launch and availability of its novel new lung health monitoring device – Spiro PD. Recently cleared by the U.S. Food and Drug Administration (FDA), Spiro PD is the first and only personal spirometer...

Cook Medical Renews Contract with Premier Healthcare Alliance, Extends Pricing Agreements on Specialty Urology Products for More than 2,500 U.S. Hospitals

January 24, 2012 5:18 am | News | Comments

Bloomington, Ind. – Hospitals around the country have three more years of access to a specialty urology agreement with an extensive line of specialty urology products at special pricing after Cook Medical and the Premier healthcare alliance renewed their contract to provide Cook's urology products...

Toshiba Installs 1,200th Vantage MR System Worldwide

January 24, 2012 5:06 am | News | Comments

TUSTIN, Calif.--(BUSINESS WIRE)--To provide patient-friendly MR imaging, Banner Good Samaritan Medical Center in Phoenix, Ariz., has installed a Vantage Titanâ„¢ 1.5T MR system from Toshiba America Medical Systems, Inc., which is the 1,200th Vantage MR installed worldwide.

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European Launch Of Penumbra Separator 3D Announced At The Working Group In Interventional Neuroradiology (WIN) Seminar

January 24, 2012 5:03 am | News | Comments

VAL D'ISERE, France--(BUSINESS WIRE)--At last week's ABC-WIN Seminar, Prof. Dr. Michael Knauth, Director of Neuroradiology, University Hospital of Goettingen, Goettingen, Germany, and President-elect of the German Society of Neuroradiology, presented the European evaluation...

Appeals Court Will Consider Patent Infringement Case En Banc

January 24, 2012 4:53 am | News | Comments

PORTLAND, Ore.--(BUSINESS WIRE)--HemCon Medical Technologies, Inc., announced today that the U.S. Court of Appeals for the Federal Circuit (CAFC) will rehear en banc HemCon's appeal of the patent infringement case brought by Marine Polymer Technologies, Inc.

Guided Therapeutics Submits CE Mark Approval Application for LuViva Advanced Cervical Scan

January 24, 2012 4:50 am | News | Comments

NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. today announced that it has submitted the application for CE Mark approval for LuViva® Advanced Cervical Scan. The CE Mark is required to market LuViva in the 27 nations that comprise the European Union (EU).

FzioMed Receives CE Mark for DYNAVISC Gel

January 24, 2012 4:46 am | News | Comments

SAN LUIS OBISPO, Calif.--(BUSINESS WIRE)--FzioMed, Inc. is pleased to announce that it has received CE Mark approval to market DYNAVISC® adhesion barrier gel in Europe for tendon and peripheral nerve surgery. DYNAVISC is a clear, absorbable gel supplied ready-to-use...

Medtronic Announces 510(k) Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

January 24, 2012 4:44 am | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) for the Aquamantys® SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the company's Advanced Energy business.

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VasoStitch Completes Successful In Vivo Study of Its Breakthrough Access-and-Closure System for Nonsurgical Deployment of Transcatheter Therapies

January 24, 2012 4:41 am | News | Comments

DANVILLE, Calif.--(BUSINESS WIRE)--VasoStitch, a start-up medical technology company, announced today that it has successfully completed its first in vivo study of its percutaneous access-and-closure system for the nonsurgical deployment of large-diameter transcatheter therapeutic devices...

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).

Tennessee Hip Replacement Patient Files Suit Against DePuy For Alleged Debilitating Injuries

January 23, 2012 5:51 am | News | Comments

NASHVILLE, Tenn.--(BUSINESS WIRE)--Kathryn E. Barnett of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Paul McCurley of Chattanooga, Tennessee, has filed a lawsuit against DePuy Orthopaedics, Inc., and its parent company, Johnson & Johnson...

CardioComm Solutions, Inc. Receives FDA Clearance to Market First Over-the-Counter Heart Monitoring Solution

January 23, 2012 5:44 am | News | Comments

TORONTO--(BUSINESS WIRE)--CardioComm Solutions, Inc., a global medical provider of ECG acquisition and management software solutions, received clearance from the Food and Drug Administration (FDA) for over-the-counter (OTC) sales and marketing of their consumer-based...

Precision Pulmonary Diagnostics to Offer OSA Portable Monitor Testing

January 23, 2012 5:42 am | News | Comments

HOUSTON--(BUSINESS WIRE)--Precision Pulmonary Diagnostics (PPD®) recently added portable monitor testing to its diagnostic offerings of sleep apnea in commercial drivers. PPD is an industry leader, providing turn-key sleep apnea disease management program and lab network.

Acacia Subsidiary Acquires Patents for Catheter Ablation Technology

January 23, 2012 5:37 am | News | Comments

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--Acacia Research Corporation announced today that a subsidiary has acquired patents relating to catheter ablation technology. “Acacia continues to increase the number of patent portfolios we control in the medical technology sector,” commented Paul Ryan...

Medgenics' Receives Allowance for Key European Patent

January 23, 2012 5:30 am | News | Comments

MISGAV, Israel & SAN FRANCISCO--(BUSINESS WIRE)--Medgenics, Inc., the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that the Company received notice of ‘Intention to Grant'...

Guided Therapeutics Provides Update on PMA Application for LuViva Advanced Cervical Scan and Timing for Filing of CE Mark

January 23, 2012 5:27 am | News | Comments

NORCROSS, Ga.--(BUSINESS WIRE)--Guided Therapeutics, Inc. today announced that the company plans to seek an independent panel review of its Pre-market Approval (PMA) application for the LuViva® Advanced Cervical Scan from the U.S. Food and Drug Administration (FDA)...

Nanomedical Global Sales to Reach $130.9 Billion in 2016

January 23, 2012 5:24 am | News | Comments

Wellesley, Mass. – According to a new technical market research report, NANOTECHNOLOGY IN MEDICAL APPLICATIONS: THE GLOBAL MARKET (HLC069B) from BCC Research, nanomedical global sales totaled $72.8 billion in 2011 and are expected to increase...

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). 

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