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Smiths Medical to establish wholly-owned subsidiary in India

Smiths Medical, a leading global medical device manufacturer, today announced it is to establish a wholly-owned subsidiary in Mumbai, India, to help grow its business in this vitally important part of the world.

18 Jan 2011

ICON announces acquisition of Oxford Outcomes

ICON plc,, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the expansion of its Late Phase and Outcomes Research services through the acquisition of Oxford Outcomes, a leading international health outcomes consultancy.

14 Jan 2011

U.S. Marshals seize Rite-Dent's dental devices

U.S. Marshals, acting under a court order sought by the U.S. Food and Drug Administration, on Jan. 5 and 6, seized all dental devices from Rite-Dent Manufacturing Corporation, located in Hialeah, Fla.

14 Jan 2011

Wright launches DARCO Foot & Ankle Plating System in Japan

Wright Medical Group, Inc., a global orthopaedic medical device company, today announced the launch of the DARCO® Foot & Ankle Plating System in Japan. The DARCO® Plating System consists of over 40 different locked plates specifically designed to meet the needs of foot and ankle surgeons. Wright has been selling the DARCO® Plating System in the United States and other key global markets since 2007.

12 Jan 2011

ZOLL announces successful conclusion of Circulation Improving Resuscitation Care trial

ZOLL Medical Corporation, a manufacturer of medical devices and related software solutions, announced today the successful conclusion of the ZOLL-sponsored CIRC trial. The trial's Data Safety Monitoring Board (DSMB) closed enrollment when an analysis of the data showed the load-distributing band (AutoPulse® Non-invasive Cardiac Support Pump) to be equivalent to manual chest compressions.

12 Jan 2011

Surge in cataract surgeries fuels intraocular lens market to almost $1.4 billion

According to two new reports by iData Research, the leading global authority in medical device and pharmaceutical market research, growth in the use of optical coherence tomography (OCT) for the detection of ocular conditions will drive the U.S. diagnostic ophthalmic market to over $650 million by 2017.

12 Jan 2011

Rice, BCM discovery addresses key roadblock to growing replacement tissues, organs

Researchers from Rice University and Baylor College of Medicine (BCM) have broken one of the major roadblocks on the path to growing transplantable tissue in the lab: They've found a way to grow the blood vessels and capillaries needed to keep tissues alive.

12 Jan 2011

CE mark approves Vitrolife's SpermFreeze Solution

SpermFreeze Solution, which is used for freeze storage of sperm, has obtained a CE mark and is thereby approved for sales within the European Economic Area.

12 Jan 2011

Advisers poised to determine which insurance benefits are 'essential'

Meetings begin this week to determine what benefits insurers must cover under the new health law. The resulting regulation will be just one of the ways in which the new health law will change the health care landscape.

12 Jan 2011

Avinger raises $25 million for catheter development and commercialization

Avinger, Inc., medical device manufacturer of innovative, multi-functional catheters for treating peripheral artery disease (PAD), recently completed a $25 million Series B round of funding from a syndicate of highly successful entrepreneurs and executives.

12 Jan 2011

Acne bacterium may also cause infections all over the body

A bacterium which causes acne and is commonly found on the skin, is now known to cause infections all over the body. Propionibacterium acnes (P. acnes)5 has been associated with infections of artificial joints and heart valves (endocarditis), as well as eye infections and chest infections - which are common at this time of year.

12 Jan 2011

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro in Germany and the UK

Aradigm Corporation today announced that Zogenix, Inc. and Desitin Pharmaceuticals GmbH were granted approval of the Marketing Authorization Application for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache by the Federal Institute for Drugs and Medical Devices of Germany (BrArM) and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA).

11 Jan 2011

Current and anticipated regulatory landscape for manufacturers of home healthcare equipment

Underwriters Laboratories (UL), a world leader in safety testing and certification, announced today the release of a white paper that addresses the current and anticipated regulatory landscape for manufacturers of home healthcare equipment. The white paper, "Home Healthcare Equipment: An Overview," examines the new IEC 60601-1-11 standard, and highlights the unique challenges for manufacturers with the U.S. Food and Drug Administration's (FDA) recently announced Medical Device Home Initiative.

11 Jan 2011

American Heart Association: CPR training is essential for all secondary school students

All secondary school students should be required to be trained in cardiopulmonary resuscitation and receive an overview of automated external defibrillators, according to an American Heart Association science advisory.

11 Jan 2011

AlloSource, Wright Medical Group enter supply and distribution agreement for FUSIONFLEX graft

Wright Medical Group, a global orthopaedic medical device company, today announced a supply and distribution agreement with AlloSource for FUSIONFLEX™ Bone Matrix, a unique bone repair scaffold for use in primary fusion procedures of the foot and ankle, as well as other orthopaedic bone grafting applications.

11 Jan 2011

MAKO sells 13 Robotic Arm Interactive Orthopedic Systems during fourth quarter 2010

MAKO Surgical Corp., a medical device company that markets both its RIO® Robotic Arm Interactive Orthopedic surgical platform and proprietary RESTORIS® implants for minimally invasive orthopedic procedures known as MAKOplasty®, today announced its selected operating results for its fourth quarter ended December 31, 2010

10 Jan 2011

Genetics Squared to change corporate name to Everist Genomics

Genetics Squared, a prognostics company focused on developing gene-based molecular assays for the prediction of cancer recurrence, today announced that it will change its corporate name to Everist Genomics and has appointed Prasad Sunkara, Ph.D. as its new President and Chief Executive Officer, effective immediately.

10 Jan 2011

Mindray anticipates $703 million net revenue for 2010

Mindray Medical International Limited, a leading developer, manufacturer and marketer of medical devices worldwide, today announced selected preliminary, unaudited results for the fiscal year ended December 31, 2010.

From Mindray 10 Jan 2011

Manhattan enters settlement and release agreement with Nordic and H Pharmaceuticals

Manhattan Pharmaceuticals, Inc. announced that on January 4, 2011, the company entered into a settlement and release agreement with Nordic Biotech Fund II K/S and H Pharmaceuticals K/S. Manhattan Pharmaceuticals and Nordic are partners in the H Pharmaceuticals joint venture for the development and commercialization of Hedrin®, a non-pesticide treatment for head lice.

10 Jan 2011

CMI, TriReme Medical sign agreement to distribute peripheral and coronary balloon dilatation catheters

TriReme Medical, today announced that it has signed an exclusive distribution and sales agreement for TriReme's complete line of advanced peripheral and coronary balloon dilatation catheters with Century Medical, a leading independent device distributor for the important Japanese market.

10 Jan 2011

Medical Devices News and Research

Smiths Medical to establish wholly-owned subsidiary in India

ICON announces acquisition of Oxford Outcomes

U.S. Marshals seize Rite-Dent's dental devices

Wright launches DARCO Foot & Ankle Plating System in Japan

ZOLL announces successful conclusion of Circulation Improving Resuscitation Care trial

Surge in cataract surgeries fuels intraocular lens market to almost $1.4 billion

Rice, BCM discovery addresses key roadblock to growing replacement tissues, organs

CE mark approves Vitrolife's SpermFreeze Solution

Advisers poised to determine which insurance benefits are 'essential'

Avinger raises $25 million for catheter development and commercialization

Acne bacterium may also cause infections all over the body

Zogenix, Desitin receive MAA approval for SUMAVEL DosePro in Germany and the UK

Current and anticipated regulatory landscape for manufacturers of home healthcare equipment

American Heart Association: CPR training is essential for all secondary school students

AlloSource, Wright Medical Group enter supply and distribution agreement for FUSIONFLEX graft

MAKO sells 13 Robotic Arm Interactive Orthopedic Systems during fourth quarter 2010

Genetics Squared to change corporate name to Everist Genomics

Mindray anticipates $703 million net revenue for 2010

Manhattan enters settlement and release agreement with Nordic and H Pharmaceuticals

CMI, TriReme Medical sign agreement to distribute peripheral and coronary balloon dilatation catheters

Industry Focus eBook - Medical Devices (3rd Edition) eBook

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