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Which Way to Go: CE Mark or FDA Approval?

February 7, 2012 10:30 am | by Charlie Chi, Ph.D. | Articles | Comments

Start-ups and large device makers alike have difficulty bringing new products to market without greater predictability and transparency from the FDA. According to an online survey funded by the medical technology industry’s Institute for Health Technology Studies, most medical device companies today are seeking regulatory approval and launching their products overseas first. This article will look at whether this is a good business decision for all device manufacturers.

Genetic variant increases risk of common type stroke

February 5, 2012 11:46 am | by EurekAlert | News | Comments

(Wellcome Trust) A genetic variant that increases the risk of a common type of stroke has been identified by scientists in a study published online in Nature Genetics today. This is one of the few genetic variants to date to be associated with risk of stroke and the discovery opens...

Irish Medical Device Association: Vibrant Med Tech Sector in Ireland Identifies Continued Evolution & Convergence in 4 Year Plan

February 2, 2012 5:17 am | News | Comments

DUBLIN--(BUSINESS WIRE)--Over the last twelve months, medical technology companies publically announced the investment of approximately €170m and the creation of an estimated 875 jobs in Ireland over the coming years, according to the Irish Medical Device Association (IMDA)...


Cook Medical Launches Zenith Low Profile Endovascular Graft in Canada

February 1, 2012 5:28 am | News | Comments

Stouffville, Ontario-Following Health Canada approval, the Zenith Low Profile AAA Endovascular Graft (Zenith AAA LP) from Cook Medical is now approved and will be launched to physicians in Canada. With a low-profile delivery system diameter of 18 Fr and simplified deployment...

Singapore Scientists Lead in 3D Mapping of Human Genome to Help Understand Human Diseases

February 1, 2012 5:20 am | News | Comments

Singapore - (ACN Newswire) - Genome Institute of Singapore's (GIS) Associate Director of Genomic Technologies, Dr Yijun RUAN, led a continuing study on the human genome spatial/structural configuration, revealing how genes interact/communicate and influence each other, even when...

Company Brings Cancer Detection Test, Jobs to Hershey

January 31, 2012 5:31 am | News | Comments

HERSHEY, Pa.--(BUSINESS WIRE)--Hershey Center for Applied Research (HCAR) prepares to welcome another international company to its thriving research facility. Based in Dunedin, New Zealand, Pacific Edge Diagnostics, Ltd., a leading developer of cancer diagnostic and prognostic...

Bruker Acquires Hecus MICROcaliX Product Line to Expand Product Portfolio for Small Angle X-ray Scattering (SAXS)

January 27, 2012 4:59 am | News | Comments

KARLSRUHE, Germany--(BUSINESS WIRE)--Bruker AXS GmbH announced today that it has acquired the assets of Hecus X-ray Systems GmbH, a company focused on analytical instrumentation for Small Angle X-ray Scattering (SAXS) based on advanced Kratky technology.

Cambridge Team First to Grow Smooth Muscle Cells from Patient Skin Cells

January 26, 2012 5:27 am | News | Comments

Singapore - (JCN Newswire) - A Cambridge University research team has for the first time discovered a method of generating different types of vascular smooth muscle cells (SMCs) - the cells which make up the walls of blood vessels - using cells from patients' skin. This work could lead...


Systagenix announces CE mark and first commercial shipment of WOUNDCHEK Protease Status, making it the world's first point-of-care diagnostic test for chronic wounds

January 25, 2012 5:39 am | News | Comments

GATWICK, England--(BUSINESS WIRE)--Wound care clinicians' calls for better diagnostic tools to aid wound assessment have today been answered with the CE marking of WOUNDCHEKâ„¢ Protease Status, the world's first rapid, point-of-care diagnostic test developed specifically for chronic wounds.

Ukraine Fortifies Cancer Management Capabilities with New Elekta Technology

January 25, 2012 5:10 am | News | Comments

KYIV, Ukraine /PRNewswire/ -- The Rinat Akhmetov (Development of Ukraine) Foundation took bold strides in 2011 to advance patient care by acquiring a comprehensive range of cancer management technology to equip the radiotherapy department at Rivne Regional Oncologic Dispensary in Ukraine.

FDA OKs Genzyme's Framingham plant

January 24, 2012 9:48 pm | by Mass High Tech: The Journal of New England Technology | News | Comments

Less than a week after Genzyme's Framingham plant landed approval from the European Medicines Agency to manufacture Fabrazyme, the U.S. Food and Drug Administration has also given the OK to produce the treatment for Fabry disease.

ACT stem cell trial in U.S. shows signs of safety

January 24, 2012 9:48 pm | by Mass High Tech: The Journal of New England Technology | News | Comments

Advanced Cell Technology Inc. today released data from a U.S. clinical trial testing the safety of treating Stargardt's macular dystrophy with human embryonic stem cell-derived retinal pigment epithelium (RPE) cells.

A-STAR, GE Global Research Join Forces to Develop Integrated Advanced Medical Imaging Technologies

January 23, 2012 5:02 am | News | Comments

Singapore - (ACN Newswire) - GE Global Research, the central technology development arm for GE Healthcare and all of GE's businesses, has signed a Memorandum of Understanding (MOU) with Singapore's Agency of Science, Technology and Research (A*STAR).


European Coronary Stent Market to Decline to $490 Million by 2016, Despite Growth in Number of Procedures

January 20, 2012 5:06 am | News | Comments

TORONTO--(BUSINESS WIRE)--According to Millennium Research Group (MRG), the global authority on medical technology market intelligence, while the number of coronary stenting procedures performed will show steady growth, stent selling prices will decline significantly...

Sunovion plans to layoff asthma drug reps

December 28, 2011 9:47 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Sunovion Pharmaceuticals, which is owned by Japanese drug maker Dainippon Sumitomo Pharma, confirmed last week that it will lay off an undisclosed number of sales representatives that are responsible for selling the company's asthma drugs.

Momenta, Baxter form potential $450M generic drug deal(3)

December 23, 2011 10:46 pm | by Mass High Tech: The Journal of New England Technology | News | Comments

Momenta Pharmaceuticals Inc., a Cambridge-based developer of novel and generic drugs, has formed a $33 million collaboration deal with Baxter International Inc. that could balloon to more than $450 million with possible milestone payments included.

Momenta, Baxter form potential $480M generic drug deal

December 23, 2011 4:47 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Momenta Pharmaceuticals Inc., a Cambridge-based developer of novel and generic drugs, has formed a $33 million collaboration deal with Baxter International Inc. that could balloon to more than $480 million including possible milestone payments.

Curis lands $6M pay for cancer drug review in Europe

December 22, 2011 6:47 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Curis Inc. has $6 million more in its coffers from a milestone payment after its collaborator Roche submitted its small molecule cancer drug candidate, vismodegib, to the European Medicines Agency for approval in treating advanced basal cell carcinoma.

Heart disease study highlights Scottish ethnic groups most at risk

December 21, 2011 7:47 am | by EurekAlert | News | Comments

(University of Edinburgh) Scots of Pakistani origin are 50 percent more likely to be admitted to hospital with chest pain and angina than those of Indian ethnicity, a study has found.Scots of Indian and Pakistani origin also have much greater levels of hospital admissions for both...

Millennium adding two cancer programs via Intellikine buy

December 21, 2011 7:47 am | by Mass High Tech: The Journal of New England Technology | News | Comments

Millennium: The Takeda Oncology Company will add two cancer drug candidates as part of Japanese parent Takeda Pharmaceutical Company Ltd.'s acquisition of Intellikine Inc. of La Jolla, Calif., Takeda said today.

Even limited telemedicine could improve developing health

December 21, 2011 4:47 am | by EurekAlert | News | Comments

(Inderscience Publishers) A lack of infrastructure in developing countries, and particularly in rural areas, often ensures that healthcare provision is absent. Research published in the International Journal of Services, Economics and Management by a team at Howard University in...

HIV/AIDS vaccine developed at Western proceeding to human clinical trials

December 21, 2011 1:48 am | by EurekAlert | News | Comments

(University of Western Ontario) The first and only preventative HIV vaccine based on a genetically modified killed whole virus has received approval by the United States Food and Drug Administration (FDA) to start human clinical trials.Developed by Dr. Chil-Yong Kang and his team...

Aquatic therapy soon after total knee arthroplasty improves outcomes

December 21, 2011 1:47 am | by EurekAlert | News | Comments

(Elsevier Health Sciences) According to a new study published in the Archives of Physical Medicine and Rehabilitation, beginning aquatic therapy just six days after total knee arthroplasty may lead to improved results, while delaying its onset an additional week may be more...

Diagnosis, treatment of depression among elderly depend on racial, cultural factors

December 21, 2011 1:46 am | by EurekAlert | News | Comments

(Rutgers University) Despite improvements to diagnostic tools and therapies in the two last decades, significant disparities in the diagnosis and treatment of depression remain, according to Rutgers research.

Removal of lymph nodes during surgery for thyroid cancer may be beneficial

December 20, 2011 10:47 am | by EurekAlert | News | Comments

(University of California - Los Angeles Health Sciences) Papillary thyroid cancer accounts for the majority of all thyroid malignancies, which primarily impact women. A new study indicates that routinely removing lymph nodes in the neck in these cancer patients may help prevent the...

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