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K2M Announces Global Launch of CHESAPEAKE® Anterior-Lumbar Stabilization System at 2011 North American Spine Society Annual Meeting

November 4, 2011 6:25 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 the global launch of the latest product within the family of CHESAPEAKE® Stabilization Systems...

PhysioSonics to Optimize Cerebral Blood Flow Monitor for Military Use

November 4, 2011 6:01 am | News | Comments

BELLEVUE, Wash., Nov. 3, 2011 /PRNewswire/ -- PhysioSonics announced today that it received a $2.5 million grant from the Telemedicine and Advanced Technology Research Center. TATRC is an organization within the headquarters of the U.S. Army Medical Research and Materiel Command...

Manufacturing Microscale Medical Devices for Faster Tissue Engineering

November 2, 2011 8:27 pm | News | Comments

WASHINGTON--(BUSINESS WIRE)--In the emerging field of tissue engineering, scientists encourage cells to grow on carefully designed support scaffolds. The ultimate goal is to create living structures that might one day be used to replace lost or damaged tissue, but the manufacture of appropriately detailed scaffolds...

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Arterial Remodeling Technologies (“ART") reports that its second-generation bioresorbable stent promotes vessel lumen enlargement in post-angioplasty in vivo model

November 2, 2011 8:23 pm | News | Comments

PARIS--(BUSINESS WIRE)--Arterial Remodeling Technologies (“ART”) reported today that in vivo data strongly suggest that its second-generation bioresorbable stent promotes positive arterial remodeling in a post-angioplasty porcine model at three months follow-up.

K2M Announces Global Launch of EVERESTâ„¢ Degenerative Spinal System at 2011 North American Spine Society Annual Meeting

November 2, 2011 8:19 pm | 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 the global launch of the EVERESTâ„¢ Degenerative Spinal System at the 2011 North American Spine Society Annual Meeting (NASS) in Chicago.

Medtronic Introduces New Procedure for Minimally Invasive Spinal Fusion

November 2, 2011 8:16 pm | News | Comments

MEMPHIS, Tenn.--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) the world leader in spinal technology, announced today a pioneering approach to minimally invasive spinal fusion at the 26th annual meeting of the North American Spine Society in Chicago, IL.

Medtronic Begins Transcatheter Aortic Valve Trial in Japan

November 2, 2011 8:09 pm | News | Comments

MINNEAPOLIS--(BUSINESS WIRE)--Medtronic, Inc. (NYSE: MDT) today announced the first implant in a clinical trial in Japan that will evaluate the safety and effectiveness of the Medtronic CoreValve® System. The successful procedure in the trial was led by Professor Yoshiki Sawa

Second Sight Announces First Commercial Implant of Retinal Prosthesis

November 2, 2011 8:05 pm | News | Comments

LAUSANNE, Switzerland--(BUSINESS WIRE)--Second Sight Medical Products, Inc., the world's leading developer of retinal prostheses for the blind, announced that the first ever commercial implantation of such a prosthesis was successfully completed on Saturday, October 29th in Pisa, Italy.

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Orthofix International Announces Launch of Collageâ„¢ Synthetic Bone Graft Substitute

November 2, 2011 7:54 pm | News | Comments

LEWISVILLE, Texas--(BUSINESS WIRE)--Orthofix International (NASDAQ: OFIX) announces the full market release of Collageâ„¢ Osteoconductive Scaffold, a new bone graft substitute, for use in spine and orthopedic indications, at this week's North American Spine Society (NASS) meeting to be held in Chicago, Illinois.

U.S. Senators, Clinicians and People with Type 1 Diabetes Urge FDA to Issue Clear and Reasonable Guidance on Artificial Pancreas

November 2, 2011 7:32 pm | News | Comments

Washington, D.C. – U.S. Senators, clinical experts, and people with type 1 diabetes (T1D) today urged the Food and Drug Administration (FDA) to issue clear and reasonable guidance on the artificial pancreas (AP) that avoids unnecessary delays in development and delivery of a medical technology...

Meeting Materials for National Mammography Quality Assurance Advisory Committee meeting on November 4, 2011

November 2, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

The National Mammography Quality Assurance Advisory Committee advises on developing appropriate quality standards and regulations for the use of mammography facilities.

LDR Announces FDA Clearance of the ROI-A® Oblique ALIF Cage

November 2, 2011 4:28 am | News | Comments

AUSTIN, Texas--(BUSINESS WIRE)--LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced that it has received 510(k) clearance from the United States Food and Drug Administration to market the ROI-A Oblique ALIF cage.

Ascom's Mobile Monitoring Gateway Achieves MDD Clearance

November 2, 2011 4:24 am | News | Comments

GOTHENBURG, Sweden--(BUSINESS WIRE)--Ascom Wireless Solutions, a leading supplier of mission critical on-site wireless communications announced today that they have received Medical Device Directive clearance by the Swedish Medical Products Agency for their Mobile Monitoring Gateway (MMG).

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New Brain Aneurysm Treatment at Stanford Hospital Supplies Hope

November 2, 2011 4:22 am | News | Comments

STANFORD, Calif.--(BUSINESS WIRE)--If Barbara Maluo's brain aneurysm had been discovered a few months ago, she would have had few viable treatment options. She was one of the 10 to 15 percent of brain aneurysm patients diagnosed each year with aneurysms so large and wide...

Invuity Introduces Advanced Illuminated Surgical Devices for Spinal Procedures

November 2, 2011 4:18 am | News | Comments

CHICAGO, Nov. 2, 2011 /PRNewswire/ -- Invuity, a leading developer of state-of-the-art illuminated surgical technology, today announced that it will introduce a new line of surgical devices that provide surgeons enhanced visibility during spinal surgeries.

Solvay Announces Integra LifeSciences Agreement to Use Eviva® PSU in Integra's Brain Shunt Valves

November 2, 2011 4:06 am | News | Comments

ALPHARETTA, Ga., November 1, 2011– Implantable brain shunt valves from Integra LifeSciences Corporation, Plainsboro, N.J., a leading medical device manufacturer, are partially composed of Eviva® polysulfone (PSU) resin from Solvay Specialty Polymers USA, LLC. Eviva PSU resin is part of Solvay's...

DSM's Dyneema Purity® fiber selected for use in SpineWorks, LLC's new Universal Screw Persuader

November 2, 2011 3:52 am | News | Comments

DSM, a global leader in biomedical materials, today announced that its Dyneema Purity® ultra-high-molecular-weight-polyethylene fiber was selected for use in SpineWorks, LLC's novel Universal Screw Persuader (USP)System. The patent pending USP is a Class 1 disposable system...

Mazor Robotics Systems Guide Placement of Over 15,000 Spine Implants WorldwideMazor Robotics Systems Guide Placement of Over 15,000 Spine Implants Worldwide

November 1, 2011 9:37 pm | News | Comments

CAESAREA, Israel--(BUSINESS WIRE)--Mazor Robotics Ltd (TASE: MZOR), the pioneer in innovative surgical robots and complementary products for spine surgery, announced that its clinically proven technology has been used to guide placement of more than 15,000 spinal implants...

Stratatech Awarded $4.6-Million Clinical Trial Grant for ExpressGraftâ„¢ Antimicrobial Skin Substitute

November 1, 2011 8:46 pm | News | Comments

MADISON, Wis.--(BUSINESS WIRE)--Stratatech Corp., a leader in regenerative medicine, today announced that the company has been awarded a $4.6-million grant by the National Institute of Diabetes and Digestive and Kidney Diseases to support the first human clinical trial of Stratatech's ExpressGraftâ„¢ antimicrobial skin substitute.

ROX Medical Announces First Clinical Use of the ROX FLO2W Procedure for the Treatment of High Blood Pressure in Resistant Hypertension Patients

November 1, 2011 8:42 pm | News | Comments

SAN CLEMENTE, Calif.--(BUSINESS WIRE)--ROX Medical, Inc., a world leader in the development of unique minimally invasive medical devices for the treatment of advanced COPD and resistant hypertension, today announced the first clinical use of the ROX CO2UPLERTM at the Universitair Ziekenhuis Brussel...

Zynex Expands Product Line

November 1, 2011 8:39 pm | News | Comments

LONE TREE, Colo.--(BUSINESS WIRE)--Zynex, Inc. (OTCBB: ZYXI), a provider and developer of non-invasive medical devices for electrotherapy, stroke rehabilitation, neurological diagnosis and cardiac monitoring, announced that it has signed a private labeling and distribution agreement with ActivaTek...

Toshiba's Dual Plane X-Ray System Enables Faster and Easier Cardiac, Peripheral Interventions for Patients

November 1, 2011 8:34 pm | News | Comments

NEW ORLEANS--(BUSINESS WIRE)--Enabling clinicians to seamlessly transition between cardiac and peripheral intervention during a single procedure, InfinixTM DP-i cardiovascular X-ray system from Toshiba America Medical Systems, Inc. will be used in eight live cases at Peripheral Angioplasty...

Public Workshop - Using Scientific Research Data to Support Pediatric Medical Device Claims, December 5, 2011

November 1, 2011 12:31 pm | by U.S. Food & Drug Administration | News | Comments

The purpose of the public workshop is to receive public comment on the use of scientific research data, including published scientific literature, to extrapolate effectiveness claims from adults to children and between pediatric subpopulations in order...

Medtronic Receives First FDA Approval of Cobalt Chromium Balloon-Expandable Stent to Treat Narrowed Iliac Arteries

October 31, 2011 9:14 am | News | Comments

MINNEAPOLIS –– Oct. 31, 2011 –– Advancing the treatment of peripheral artery disease, Medtronic, Inc. (NYSE: MDT) today announced approval by the U.S. Food and Drug Administration (FDA) of the Assurant® Cobalt Iliac Balloon-Expandable Stent System.

Understanding Barriers to Medical Device Quality

October 31, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments

Provides an in-depth look at challenges industry and the FDA face in implementing well-integrated, best-quality manufacturing practices. The report also presents recommendations on ways industry and the FDA can work to remove the perceived barriers to...

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