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Biotronik Lands Euro Approval for MRI-Friendly Heart Implants

February 22, 2013 9:29 am | by Mass Device | News | Comments

German medical device maker Biotronik won European regulatory approval for its Ilesto 7 line of MRI-friendly heart implants. The Ilesto 7 line includes cardiac resynchronization therapy defibrillator and one of the world's smallest implantable cardioverter-defibrillators, according to Biotronik.

Lab21 and IntegraGen Partner to Develop New Colorectal Cancer Diagnostic

February 22, 2013 5:09 am | by The Associated Press | News | Comments

CAMBRIDGE, England--(BUSINESS WIRE)--Feb 22, 2013--Lab21 Limited, the global specialist in personalised medicine and clinical diagnostics, has entered into an agreement with IntegraGen, a leading player in the development and marketing of molecular diagnostic testing in autism and oncology, to...

Blaze Bioscience Announces Completion of Series A Financing - Brings Total Investment to $9.8 Million

February 22, 2013 5:00 am | by The Associated Press | News | Comments

SEATTLE--(BUSINESS WIRE)--Feb 22, 2013--Blaze Bioscience, Inc., a biotechnology company dedicated to developing innovative products to improve the lives of cancer patients, today announced the completion of a Series A financing totaling $8.5 million and bringing the total funds raised since...

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Panagene Signs Off with Dako to Supply PNA Oligomer Component

February 22, 2013 3:01 am | by The Associated Press | News | Comments

DAEJEON, South Korea--(BUSINESS WIRE)--Feb 22, 2013--Panagene announced it has signed a supply agreement with Dako Denmark A/S to supply PNA oligomer key component for incorporation into Dako’s diagnostic or research products. Dako, an Agilent Technologies Company since June 2012, is a leading...

Class I Medical Device Recall: DePuy Orthopaedics, Inc. - LPS Diaphyseal Sleeve

February 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

The LPS Diaphyseal Sleeve to Diaphyseal Sleeve Base taper connection may not be sufficient to accommodate potential physiologic loads that may be transferred to the junction during normal gait activities by some patients. This may result in fracture of...

Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements - Draft Guidance for Industry and Food and Drug Administration Staff

February 22, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Defects or performance failures of marketed medical devices can pose serious risks to public health. Recalls serve both to correct a defect in current and future devices and to notify users of potential risks and steps to minimize the impact of device...

Molecule Helps Nanoparticles Sneak Past the Immune System

February 21, 2013 5:11 pm | by Massachusetts Institute of Technology | News | Comments

Researchers have given nanoparticles the ability to tell immune cells not to eat them, a development that could have broad implications for medicine.Taking a cue from nature, researchers have designed nanoparticles that can avoid being destroyed by the immune system by convincing immune cells that the particles are part of the body.

Iowa Resident Brings Suit Against Stryker For Damages Caused By Recalled Hip Implant

February 21, 2013 5:01 pm | by The Associated Press | News | Comments

NEW YORK--(BUSINESS WIRE)--Feb 21, 2013--Wendy Fleishman and Lexi J. Hazam of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Karla Krogman of West Des Moines, Iowa, filed a lawsuit against Stryker Orthopaedics charging that the company manufactured...

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Tornier Reports Fourth Quarter and Fiscal Year 2012 Results and Provides 2013 Outlook

February 21, 2013 4:05 pm | by The Associated Press | News | Comments

AMSTERDAM--(BUSINESS WIRE)--Feb 21, 2013--Tornier N.V. (NASDAQ: TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, reported today its financial results for the fourth quarter and fiscal year ended December 30, 2012. Revenue for the...

Tornier Names David H. Mowry President and Chief Executive Officer

February 21, 2013 4:05 pm | by The Associated Press | News | Comments

AMSTERDAM--(BUSINESS WIRE)--Feb 21, 2013--Tornier, N.V. (NASDAQ: TRNX), a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, announced today that its Board of Directors has appointed David H. Mowry as President and Chief Executive Officer,...

NMMC Physicians Implant State's First Vagal Nerve Stimulator for Heart Failure

February 21, 2013 3:39 pm | by The Associated Press | News | Comments

Doctors at North Mississippi Medical Center recently implanted the state's first vagal nerve stimulator as part of a clinical research study to treat heart failure through nerve stimulation in the neck. According to cardiac electrophysiologist Karl Crossen, M.D., and neurosurgeon Louis...

Intrasense wins a contract to equip 15 hospitals in the United States for a clinical study

February 21, 2013 1:00 pm | by The Associated Press | News | Comments

MONTPELLIER, France--(BUSINESS WIRE)--Feb 21, 2013--Regulatory News: Intrasense (Paris:ALINS) (FR0011179886 - ALINS), a specialist in multimodal medical imaging, today announced that it would fit its platform in 15 hospitals in the USA as part of a clinical trial conducted by a new client, a US...

OrbusNeich Rides Patent Win Over Boston Scientific to Germany, Netherlands

February 21, 2013 12:24 pm | by Mass Device | News | Comments

OrbusNeich is taking a recent patent infringement win against Boston Scientific even further, filing lawsuits in both Germany and the Netherlands to allege patent infringement over stent technology. OrbusNeich claims Boston Scientific's Promus Element, Promus Element Plus, Taxus, and other stents are infringing on a pair of patents.

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Humetrix Launches Cross-Platform iBlueButton Mobile Apps Enabling Patient-Physician Exchange of Health Records Between Apple and Android Devices

February 21, 2013 12:16 pm | News | Comments

Humetrix today introduced cross- platform capability for its award-winning iBlueButton® apps, enabling consumers and physicians for the first time to securely exchange health records and other clinical information at the point of care, regardless of whether they use an iPhone®, iPad® or Android® smartphone.

Game Ready Introduces First-Ever Cold and Compression System For Traumatic Amputees

February 21, 2013 12:01 pm | by Game Ready | News | Comments

Game Ready has announced the launch of a new line of revolutionary wraps designed specifically for patients with amputated limbs. It is the first-ever cold and compression system available for traumatic amputees, which can be used immediately post-op to help speed up the healing process and reduce pain without use of narcotic medications. 

Covidien Closes Enrollment in Iliac Stent Studies

February 21, 2013 11:38 am | by Mass Device | News | Comments

Covidien said it closed enrollment in a pair of its Visibility and Durability iliac stent clinical studies. The prospective, multinational studies are designed to compare balloon stents with self-expanding stents in the iliac arteries for treating peripheral artery disease.

MPEG LA Continues to Expand Librassay® with Addition of WARF

February 21, 2013 10:00 am | by The Associated Press | News | Comments

DENVER--(BUSINESS WIRE)--Feb 21, 2013--MPEG LA today announced that the Wisconsin Alumni Research Foundation (WARF) has become a participating patent holder in Librassay, MPEG LA’s licensing supermarket of diagnostic and research tool patent rights for tests and assays, kits, tools and...

IMS Announces New Agreement with Quorum Purchasing Advantage

February 21, 2013 9:30 am | by The Associated Press | News | Comments

BIRMINGHAM, Ala.--(BUSINESS WIRE)--Feb 21, 2013--Integrated Medical Systems International, Inc. (IMS) is pleased to announce a new Strategic Service Partner agreement with  Quorum Purchasing Advantage, LLC (QPA .  IMS provides comprehensive OR and Sterile Processing Department solutions that help...

eHealth Technologies and Client Outlook Announce Partnership

February 21, 2013 9:03 am | by The Associated Press | News | Comments

NEW YORK--(BUSINESS WIRE)--Feb 21, 2013--eHealth Technologies and Client Outlook Inc. announced today, full availability of eHealthViewer® ZF, a new generation image viewing platform for eHealth Connect®, a suite of solutions offered by eHealth Technologies. eHealthViewer® ZF utilizes Client...

Hospitals, Healthcare Providers to Benefit from New Premier Agreements for Instrument Containers

February 21, 2013 9:00 am | by The Associated Press | News | Comments

CHARLOTTE, N.C.--(BUSINESS WIRE)--Feb 21, 2013--The Premier healthcare alliance today announced new agreements for instrument containers have been awarded to Aesculap Inc. of Center Valley, Pa.; CareFusion of San Diego, Calif.; Case Medical Inc., a women owned business, of South Hackensack, N.J.;...

MSC Care Management and Game Ready Partner to Launch New Below-The-Knee Wrap for Amputee Patients

February 21, 2013 8:00 am | by The Associated Press | News | Comments

JACKSONVILLE, Fla.--(BUSINESS WIRE)--Feb 21, 2013--MSC Care Management, a One Call Care Management (OCCM) company, today announced that it has entered a strategic partnership with Game Ready®, the leader in injury treatment and post-operative recovery through active compression and cold...

SynCardia Total Artificial Heart Patient with End-Stage Renal Failure Recovers Kidney Function after Two Months of Support

February 21, 2013 5:51 am | by Bio-Medicine.Org | News | Comments

TUCSON, Ariz. , Feb. 21, 2013 /- At only 20 years old, Tiernee Gonzalez has been battling two major diseases for most of her young life: heart failure and kidney failure. When she became the first patient at Cincinnati Children's Hospital Medical Center to receive the SynCardia temporary Total Artificial Heart on Nov. 9, her doctors hoped it would bring her one step closer...

Silicone Gel-Filled Breast Implants

February 21, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments

Silicone gel-filled breast implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells. Silicone gel-filled breast implants are approved for breast augmentation in women...

FDA Approves Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

February 20, 2013 6:17 pm | by The Associated Press | News | Comments

IRVINE, Calif.--(BUSINESS WIRE)--Feb 20, 2013--Allergan, Inc. (NYSE: AGN) today announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market the Natrelle® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants for use in breast...

FDA Approves New Silicone-Gel Breast Implant

February 20, 2013 6:05 pm | by The Associated Press | News | Comments

The Food and Drug Administration said Wednesday that it approved a new type of breast implant from Allergan for women 22 years and older. The FDA said the Natrelle 410 implant contains silicone gel that is firmer than Allergan's older Natrelle models. Allergan's studies did not compare the safety...

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