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ICON opens new office in Manila, Philippines

ICON plc, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that it will expand its footprint in Asia-Pacific with the opening of an office in Manila, Philippines.

16 Mar 2010

Keynote speakers to discuss regenerative medicine therapies at upcoming forum

What regenerative medicine therapies are being applied to patients today? What hurdles stand between stem cell therapies and real treatments in the clinic? Keynote speakers at the upcoming inaugural Translational Regenerative Medicine Forum will discuss these topics as well as provide an update on various national and regional stem cell initiatives.

16 Mar 2010

Validated eC-SSRS solution available for prospective monitoring of suicidal ideation and behaviors

ERT, a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces a pioneering electronic self-rated version of the Columbia Suicide Severity Rating Scale (C-SSRS) to facilitate compliance with regulatory requirements for prospective monitoring of suicidal ideation and behaviors.

16 Mar 2010

InnerPulse selects Dassault Systemes' Abaqus FEA software

Dassault Systèmes, a world leader in 3D and Product Lifecycle Management (PLM) solutions, today announced that InnerPulse, a medical device company pioneering a novel technology for those patients with cardiac rhythm disorders, has selected Abaqus finite element analysis (FEA) software from the SIMULIA to assist in development of their technology designed in SolidWorks CAD software.

16 Mar 2010

Hitachi, NextDocs form partnership in document management solutions for pharmaceutical manufacturers

Hitachi, Ltd. and NextDocs Corporation today announced their newly formed partnership in document management solutions for pharmaceutical manufacturers.

16 Mar 2010

UMass Memorial Health Care implements Picis CareSuite perioperative and anesthesia solutions

Picis today announced that UMass Memorial Health Care, the largest healthcare system in Central and Western Massachusetts, has selected Picis CareSuite® perioperative and anesthesia solutions for more than 60 operating rooms in its five hospitals. UMass Memorial chose Picis integrated technology to deliver clinical documentation and financial information more quickly and accurately across the UMass Memorial Health Care system, thereby promoting quality patient care.

16 Mar 2010

FDA questions third-party review of medical devices

The Wall Street Journal: The FDA is considering ending a program that allows medical-equipment makers to have their products reviewed by third-party companies instead of by FDA officials.

15 Mar 2010

Z-Medica announces the launch of QuikClot Grant for U.S. military veterans attending Marietta College

Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced the launch of its QuikClot Grant for U.S. military veterans attending Marietta College. The $25,000 grant will support Marietta College’s Yellow Ribbon Program, which allows qualified veterans to attend the college as undergraduate students and receive full tuition scholarships.

From Medica Corporation 15 Mar 2010

St. Jude Medical announces updates to PressureWire platform at ACC and SIR annual meetings

St. Jude Medical, Inc., a global medical device company, announced several updates to its PressureWire™ platform, including a new marketing agreement with Siemens Medical Solutions USA, for the wireless PressureWire™ Aeris and the availability of the next-generation of PressureWire™ Certus technology, at the American College of Cardiology and the Society of Interventional Radiology annual meetings.

15 Mar 2010

GE Healthcare's MAC 800 ECG device to aid medical support at Vancouver 2010 Paralymipc Winter Games

GE Healthcare' announced today that the company's portable ECG (electrocardiograph) device, the MAC 800, will be implemented in both Vancouver and Whistler to help support physician care of athletes, trainers and visitors throughout the Vancouver 2010 Paralymipc Winter Games.

15 Mar 2010

Medtronic commences clinical evaluation of CoreValve transcatheter aortic valve system

Moving to expand the evidence base for the future of structural heart disease therapy, Medtronic, Inc., today announced the start of the first of several new initiatives in a robust international clinical program for its CoreValve transcatheter aortic valve system, a minimally-invasive alternative to open-heart surgery for aortic valve replacement.

15 Mar 2010

Manhattan Pharmaceuticals to merge with Ariston Pharmaceuticals

Manhattan Pharmaceuticals, Inc. today announced it has entered into a definitive agreement and plan of merger and completed the merger transaction with Ariston Pharmaceuticals, Inc., a privately-held, specialty pharmaceutical company. As a result of the merger, Ariston became a wholly owned subsidiary of Manhattan Pharmaceuticals.

12 Mar 2010

Vertos Medical announces positive results from IRB I Patient Outcomes Trial of 'mild' for LSS

Medical device company Vertos Medical Inc. has announced the release of positive results from its U.S. IRB I Patient Outcomes Trial, a prospective, investigational review board-approved, 75-patient study of mild for the treatment of lumbar spinal stenosis (LSS). Six-week clinical data have shown that patients treated with mild experience statistically and clinically significant improvement in both pain and functional ability. The data also confirmed mild’s safety, with no reports of patient complications related to the procedure or the devices.

12 Mar 2010

Minimally invasive surgical ablation for AFib: Unapproved, warns whistleblower

As reported in today's Wall Street Journal, the more than 2 million Americans with atrial fibrillation are now on notice that the over-zealous marketing tactics and incentives by manufacturers of expensive medical devices which are not approved by the U.S. Food and Drug Administration (FDA) for the treatment of atrial fibrillation are likely to be influencing doctors' and hospitals' decisions about treatment for their patients' heart conditions.

12 Mar 2010

FDA warns healthcare professionals about bogus surgical mesh products

The U.S. Food and Drug Administration today warned health care providers and consumers about counterfeit surgical mesh being distributed in the United States under the C. R. Bard/Davol brand name. Surgical mesh products are used to reinforce soft tissue where weakness exists.

11 Mar 2010

Intel, Mayo Clinic and GE launch new initiative to study care and benefits of home-based telemedicine

Emerging Healthcare Solutions, Inc. was pleased on learning the news that Intel, The Mayo Clinic and GE Healthcare have launched a new initiative to study the care and cost benefits of home-based telemedicine for elderly patients with chronic illnesses.

11 Mar 2010

NeoMed invests in CytoCore

CytoCore Inc., the developer of cost-effective products used in the practice of cytology for the detection and diagnosis of cancer and cancer related diseases, announced today that NeoMed has made an investment in CytoCore Inc.

11 Mar 2010

Rex Medical receives FDA Clearance for Cleaner Rotational Thrombectomy System

Rex Medical, L.P., today announced that it has received 510(k) Clearance from the U.S. Food and Drug Administration for the Cleaner™ Rotational Thrombectomy System. Cleaner™ technology is indicated for mechanical declotting of occluded native vessel dialysis fistulae and synthetic dialysis access grafts.

11 Mar 2010

Lorom West certifies to ISO 13485: 2003 QMS for Medical Devices

Lorom West, a premier manufacturer of custom cables, wire harnesses, PCB and high quality OEM/ODM products today announced successful certification to the ISO 13485: 2003 Quality Management Standard (QMS) for Medical Devices.

11 Mar 2010

Safeguard Scientifics' aggregate partner company revenue rises 46% in 2009

Safeguard Scientifics, Inc., a holding company that builds value in growth-stage life sciences and technology companies, today announced that aggregate revenue of its partner companies for the year was $262 million, up 46% from $179 million in 2008, exceeding the company’s 2009 guidance of $223 million to $243 million, as adjusted to reflect the inclusion of two new partner companies.

11 Mar 2010

Medical Devices News and Research

ICON opens new office in Manila, Philippines

Keynote speakers to discuss regenerative medicine therapies at upcoming forum

Validated eC-SSRS solution available for prospective monitoring of suicidal ideation and behaviors

InnerPulse selects Dassault Systemes' Abaqus FEA software

Hitachi, NextDocs form partnership in document management solutions for pharmaceutical manufacturers

UMass Memorial Health Care implements Picis CareSuite perioperative and anesthesia solutions

FDA questions third-party review of medical devices

Z-Medica announces the launch of QuikClot Grant for U.S. military veterans attending Marietta College

St. Jude Medical announces updates to PressureWire platform at ACC and SIR annual meetings

GE Healthcare's MAC 800 ECG device to aid medical support at Vancouver 2010 Paralymipc Winter Games

Medtronic commences clinical evaluation of CoreValve transcatheter aortic valve system

Manhattan Pharmaceuticals to merge with Ariston Pharmaceuticals

Vertos Medical announces positive results from IRB I Patient Outcomes Trial of 'mild' for LSS

Minimally invasive surgical ablation for AFib: Unapproved, warns whistleblower

FDA warns healthcare professionals about bogus surgical mesh products

Intel, Mayo Clinic and GE launch new initiative to study care and benefits of home-based telemedicine

NeoMed invests in CytoCore

Rex Medical receives FDA Clearance for Cleaner Rotational Thrombectomy System

Lorom West certifies to ISO 13485: 2003 QMS for Medical Devices

Safeguard Scientifics' aggregate partner company revenue rises 46% in 2009

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

Designing fluidic architecture for scalable diagnostic platforms

Evaluating new approaches for rare disease genomics

Expanding access to NMR with the Fourier 80 Duo

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