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Companies & Markets: China to be the Fastest Growing Endoscopy Devices Market Among Emerging Economies

October 25, 2011 11:02 am | News | Comments

LONDON--(BUSINESS WIRE)--Endoscopy Devices Market in Emerging Economies (India, China, Brazil) - Growing Investments in Hospitals to be the Major Growth Driver. The endoscopy devices market in the emerging economies of China, India and Brazil grew at a Compounded Annual Growth Rate (CAGR) of 4%, 3% and 3%.

Microline Surgical Announces Merger with Starion Instruments

October 25, 2011 10:59 am | News | Comments

BEVERLY, Mass.--(BUSINESS WIRE)--Microline Surgical, a leading manufacturer of reposable instruments for minimally invasive surgery, today announced that it has completed the merger of Starion Instrumentsâ„¢ Corp, a developer of surgical technology for sealing and dividing soft tissue.

US Women's Health Imaging System Market to Grow to Nearly $1.2 Billion by 2016

October 25, 2011 10:47 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the obstetrics/gynecology (OB/GYN) ultrasound system segment of the overall women's health imaging system market in the United States...

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Hospitals, Healthcare Providers to Benefit from New Premier Agreements for Dialysis Products and Accessories

October 25, 2011 10:45 am | News | Comments

CHARLOTTE, N.C.--(BUSINESS WIRE)--The Premier healthcare alliance today announced new agreements for dialysis products and accessories have been awarded to AngioDynamics of Latham, N.Y.; B Braun Medical, Inc. of Bethlehem, Pa.; Covidien...

K2M Continues its Momentum with Nine New Products at 2011 North American Spine Society Annual Meeting

October 25, 2011 10:40 am | News | Comments

LEESBURG, Va.--(BUSINESS WIRE)--K2M, Inc., a spinal device company developing innovative solutions for the treatment of complex spinal pathologies and minimally invasive procedures, today announced it will introduce five new products at the North American Spine Society (NASS) 26th Annual Meeting...

Leading Innovator Alpha-Stim Gains Support of Medical Professionals and Patients in Opposing New FDA Rule

October 25, 2011 10:37 am | News | Comments

MINERAL WELLS, Texas--(BUSINESS WIRE)--Alpha-Stim, cranial electrotherapy stimulation (CES) devices providing treatment for anxiety, depression, insomnia and pain, announces its user-supported campaign to change an FDA rule regarding Pre-Market Approval (PMA),

'Extreme EVAR and TEVAR' a Hot Topic at the International Symposium on Endovascular Therapy (ISET) 2012

October 25, 2011 7:27 am | News | Comments

MIAMI BEACH, Fla., Oct. 25, 2011 -- Endovascular aneurysm repair (EVAR) and thoracic endovascular aneurysm repair (TEVAR) take center stage at the upcoming 24th Annual International Symposium on Endovascular Therapy (ISET), which brings together...

Biological Molecules Show Their True Colors

October 25, 2011 6:52 am | News | Comments

DURHAM, N.C. -- For the first time, molecular events below the skin can be seen not only in three dimensions, but in their true color. The new method developed by Duke University bioengineers detects and shows in vivid shades of red the levels of hemoglobin being carried by blood vessels, even the tiniest ones whose diameter can be as narrow as a few red blood cells.

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Million-dollar payments to surgeons raise questions

October 25, 2011 6:26 am | News | Comments

(Reuters Health) - Orthopedic surgeons have received hundreds of millions of dollars from joint implant manufacturers in recent years, according to a report released Monday. In 2007, five device makers said they had paid surgeons more than $198 million, with 43 payments exceeding $1 million.

AtriCure heart device safe, with caveats: FDA staff

October 25, 2011 6:23 am | News | Comments

(Reuters) - AtriCure Inc's Synergy Ablation System heart-rhythm device is safe and effective, but its trial size and design raise some concerns, U.S. medical device reviewers said.

FDA Communication on Use of Jet Injectors with Influenza Vaccines

October 25, 2011 6:21 am | News | Comments

PORTLAND, Ore.--(BUSINESS WIRE)--Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free drug delivery systems, today announced that the Food and Drug Administration (FDA) has issued a communication on the use of jet injectors with influenza vaccines.

Teleflex Introduces the ArrowADVANTAGE5 â„¢ Pressure-Injectable PICC

October 25, 2011 6:14 am | News | Comments

LIMERICK, Pa.--(BUSINESS WIRE)--Teleflex Incorporated (NYSE:TFX) today announced the launch of the ArrowADVANTAGE5 pressure-injectable peripherally inserted central catheter (PICC). ArrowADVANTAGE5 provides features clinicians have come to expect in a PICC, plus five unique advantages.

Zynex Ranked 9th in Revenue Growth Among Medical Equipment Companies

October 25, 2011 6:07 am | News | Comments

LONE TREE, Colo.--(BUSINESS WIRE)--Zynex, Inc. (OTCBB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy and stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it has been ranked 127th on Deloitte's 2011 Technology Fast 500 list for revenue growth between 2006 and 2010.

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Neurosurgical and Neurovascular Device Market to Grow at Six Percent Per Year

October 25, 2011 6:01 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, the market for the specialized devices used for neurosurgical and neurovascular treatments will grow to $240 million by 2016...

Lantheus Medical Imaging Awarded Three-Year Supplier Agreements with the Premier Healthcare Alliance for Ultrasound Contrast Agent DEFINITY® and Magnetic Resonance Angiography Imaging Agent ABLAVAR®

October 25, 2011 5:49 am | News | Comments

NO. BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced it has been awarded three-year supplier contracts with Premier Purchasing Partners, L.P., the group purchasing unit of the Premier healthcare alliance, in the category of cardiac ultrasound contrast media...

Increased Durability, Safety and Effectiveness of Endovascular Prosthesis to Be Main Focus Adopted by Companies

October 24, 2011 11:29 am | by Prasanna Vadhana Kannan | Articles | Comments

Endovascular surgery, a form of minimally invasive surgery, is designed to access regions of the body through the major blood vessels. The basic technique involves the introduction of a catheter percutaneously (or through the skin) into a large blood vessel either through the femoral artery or vein found near the groin. The catheter is injected with a radio-opaque dye that can be seen on an X-ray or fluoroscopy imaging device. As the dye travels through the circulation, the real-time images seen by the radiologists assist in the diagnosis of diseases. Developments of intravascular balloons, stents and coils have allowed new therapies to evolve as alternatives to the traditional open surgeries.

Research Finds Gallium Nitride is Non-Toxic, Biocompatible – Holds Promise For Biomedical Implants

October 24, 2011 6:49 am | News | Comments

Researchers from North Carolina State University and Purdue University have shown that the semiconductor material gallium nitride (GaN) is non-toxic and is compatible with human cells – opening the door to the material's use in a variety of biomedical implant technologies.

Invuity Introduces Advanced Illuminated Surgical System for Breast Procedures

October 24, 2011 6:44 am | News | Comments

SAN FRANCISCO, Oct. 24, 2011 /PRNewswire/ -- Invuity, a leading developer of state-of-the-art illuminated surgical technology, today introduced its illuminated breast retractor system at the American College of Surgeons' 97th Annual Clinical Congress...

Letter to Manufacturers Concerning SIDS Prevention Medical Claims for Baby Products

October 17, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

The FDA has learned that some manufacturers are continuing to market baby products that claim to prevent or reduce the risks of Sudden Infant Death Syndrome (SIDS) without FDA clearance or approval. Under section 201(h) of the Federal Food Drug &..

Information on Baby Products with SIDS Prevention Claims

October 17, 2011 8:31 am | by U.S. Food & Drug Administration | News | Comments

Some baby products are being marketed over-the-counter with claims to cure, treat, or prevent a disease or condition. Because of these claims, these baby products are medical devices, subject to FDA regulation.

CooperVision Avaira Toric Soft Contact Lenses: Class 1 Recall- Unintended Residue on Lenses

October 14, 2011 5:31 pm | by U.S. Food & Drug Administration | News | Comments

Presence of a silicone oil residue on lenses from certain lots of my cause range of symptoms such as hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

MDUFMA III Proposal Delivery in Question as FDA Eyes Calendar

October 14, 2011 2:31 pm | by U.S. Food & Drug Administration | News | Comments

Industry resistance to an FDA move to fund training and hiring with user fee revenues has the agency concerned about missing a Jan. 15 deadline to give Congress proposals for the third reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA).

Device Panelists & #8217; Trial Critiques Are Killing Companies, Critics Say

October 14, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments

Device innovation is suffering because FDA conflict of interest rules keep experienced and insightful practitioners from serving on advisory panels, industry and lawmakers say.

Class I Medical Device Recall: CooperVision AVAIRA Toric Soft Contact Lenses

October 14, 2011 12:30 pm | by U.S. Food & Drug Administration | News | Comments

Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Cook Medical's Zilver PTX Drug-Eluting Stent Technology Receives Unanimous Recommendation from FDA Advisory Committee

October 14, 2011 5:38 am | News | Comments

The Zilver® PTX® Drug-Eluting Stent, the first device of its kind developed to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA), has received a unanimous recommendation from the FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee...

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