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ISO 13485:2003 accreditation to strengthen AppLabs medical device testing practice

AppLabs, the world’s largest software testing and quality management company, today announced that it has been conferred with the prestigious International Organization for Standardization (ISO) 13485:2003 certification. ISO 13485:2003 is a vehicle for harmonizing quality management system regulations in the medical device sector that consistently meet customer requirements and regulatory standards. With this, AppLabs is among the few software testing companies globally to be awarded this accreditation.

22 Mar 2010

Zenyaku Kogyo receives license to Theraclone Sciences' influenza monoclonal antibody program

Theraclone Sciences, Inc., announced that Zenyaku Kogyo Co. Ltd., has exercised its option for an exclusive license in the Japan territory to Theraclone’s influenza monoclonal antibody program. The collaboration utilizes Theraclone’s I-STAR™ technology to discover broadly protective monoclonal antibodies for the treatment of pandemic influenza and severe seasonal influenza.

22 Mar 2010

LCOA announces official launch of new website for Cielo Latino

The Latino Commission on AIDS today announced the official launch of www.latinoaids.org/cielo, its website for Cielo Latino, the largest annual national fundraiser for the Latino community in its fight against HIV/AIDS.

22 Mar 2010

Calando Pharmaceuticals demonstrates first targeted siRNA-containing nanoparticle delivery to tumors

Arrowhead Research Corporation today announced that the clinical trial being conducted by majority-owned subsidiary, Calando Pharmaceuticals, Inc., has demonstrated systemic delivery of siRNA and the successful “silencing” of a widely recognized cancer gene via RNA interference (RNAi) in humans.

22 Mar 2010

Toshiba’s new V-TRACE MRA for brain imaging

When imaging the brain, time is critical as vascular abnormalities can have a profound effect on patients’ lives if not diagnosed quickly. To help health care facilities diagnose disease with greater accuracy and speed, Toshiba America Medical Systems, Inc. has introduced Variable True Rate Angiography with Combined Encodings, an exclusive MRA sequence available on all Vantage TitanTM and Vantage Atlas® MR systems.

22 Mar 2010

iMDsoft's MetaVision suite of solutions to be distributed by Dominion in Spain

iMDsoft®, a global leader in hospital-wide clinical information systems, and Dominion, a leading provider of technology solutions in Spain and Latin America, have announced an agreement whereby Dominion will distribute iMDsoft's MetaVision® suite of solutions in Spain.

22 Mar 2010

ATS Medical receives Canadian approval for commercialization of Simulus Annuloplasty Product Line

ATS Medical, Inc., manufacturer and marketer of state-of-the-art cardiac surgery products and services today announced that Health Canada-Medical Device Bureau, Therapeutic Products Programme has approved commercialization of the ATS Simulus® Annuloplasty Product Line for valve repair.

22 Mar 2010

Aston University scientists receive grants to develop new forms of drug delivery

Before you swallow a tablet, or put it into a glass of water to dissolve, do you ever stop and think about how it actually works in your body and how quickly and effectively it can deliver the drug to where it is needed?

22 Mar 2010

ILSI Biomed Israel 2010 international conference to be held in Tel Aviv

Set against the backdrop of the global market recovery and the recent proliferation of the life sciences field, this June’s ILSI Biomed Israel 2010 international conference will be attended by the most prominent figures in the biotechnology, pharma and medical device sectors.

22 Mar 2010

Asuragen appoints BMD as exclusive distributor of Signature Oncology Products in France

Asuragen, Inc., a leader in the development of molecular diagnostics, announced today the appointment of Biomedical Diagnostics SA, a leading medical diagnostic company in Europe, as its exclusive distributor of Signature® Oncology Products in France. Asuragen’s Signature Oncology Portfolio comprises multiplex assays for the detection of mutations in solid and hematologic malignancies.

22 Mar 2010

SRI International researchers to disclose preliminary results of NTD detecting diagnostic at 239th ACS

SRI International, an independent nonprofit research and development organization, will present preliminary results of a diagnostic to detect neglected tropical diseases (NTDs) at the 239th National Meeting & Exhibition of the American Chemical Society (ACS) being held on March 21-25 in San Francisco.

22 Mar 2010

Given Imaging to purchase Sierra Scientific Instruments from Water Street Healthcare Partners for $35M

Water Street Healthcare Partners, a leading private equity firm focused exclusively on health care, announced today that it has entered into a definitive agreement to sell its gastrodiagnostic device company, Sierra Scientific Instruments, to Given Imaging Ltd ( GIVN). Given Imaging, the global leader in patient-friendly GI diagnostic and monitoring solutions, will purchase the business for $35 million in cash. The transaction is expected to close in early April.

22 Mar 2010

FDA advisory panel recommends approval for Boston Scientific's CRT-D in treatment of mild heart failure

A new therapy that reduces the risk of mortality and heart failure in patients with mild cardiac disease received a thumb's up this week from an advisory panel to the U.S. Food and Drug Administration. The panel recommended that the cardiac resynchronization therapy defibrillator (CRT-D), tested extensively nationwide under the leadership of cardiologist Arthur Moss, M.D., professor of Medicine at the University of Rochester Medical Center, be approved for use in patients with mild heart failure in the United States.

20 Mar 2010

AAHRPP re-accredits BRI

Officials announced today that Baylor Research Institute (BRI), part of the Baylor Health Care System, was recently re-accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). The re-accreditation certifies that BRI maintains efficient systems for monitoring research participant safety and embraces ethical standards higher than required by law in order to protect human participants participating in BRI research programs. Only 200 out of the thousands of human research protection programs in the U.S., Canada and abroad have earned this prestigious distinction.

20 Mar 2010

Portable ultrasound device to treat chronic joint pain from arthritis

In recent years, doctors have used ultrasound to effective treat joint pain from arthritis and other ailments without the use of drugs. The drawback to these treatments, however, is that they can only be administered in a doctor's office or clinic, since the ultrasound devices currently used are bulky and expensive.

20 Mar 2010

New device detects bacterial and fungal contamination

Microorganisms are everywhere and most of them are harmless, but they can do a lot of damage in the manufacture of pharmaceuticals or in tissue transplants. With the aid of a new device, germs can be detected in artificial cartilage within a few hours.

20 Mar 2010

Dartmouth-Hitchcock Medical Center awarded ECRI Institute Health Devices Achievement Award

Masimo, the inventor of Pulse CO-Oximetry™ and Measure-Through Motion and Low Perfusion pulse oximetry, is pleased to report that Dartmouth-Hitchcock Medical Center (Lebanon, New Hampshire) has received the 4th Annual ECRI Institute Health Devices Achievement Award yesterday for an innovative patient monitoring project that uses its Masimo SET pulse oximetry and Masimo Patient SafetyNet remote monitoring and clinician notification system.

20 Mar 2010

EUREKA project develops unique range of antibodies

EUREKA project E! 3424 RECAN has developed a range of unique and highly specific monoclonal and polyclonal antibodies - the proteins produced in the blood which counteract bacteria, viruses or cancerous cells.

20 Mar 2010

ITDS can be effective for screening fever during H1N1 influenza pandemic: UNMC researchers

Researchers at the University of Nebraska Medical Center found an Infrared Thermal Detection System to be a fast and effective fever screening tool in clinical settings during the H1N1 influenza pandemic. The ITDS detected fever in patients through split-second, non-contact skin temperature measurements.

20 Mar 2010

FDA panel favors approval with conditions of Medtronic's Revo MRI SureScan pacing system

Medtronic, Inc.today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted unanimously in favor of approval with conditions of the Revo MRI™ SureScan™ pacing system designed as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions.

20 Mar 2010

Device / Technology News

ISO 13485:2003 accreditation to strengthen AppLabs medical device testing practice

Zenyaku Kogyo receives license to Theraclone Sciences' influenza monoclonal antibody program

LCOA announces official launch of new website for Cielo Latino

Calando Pharmaceuticals demonstrates first targeted siRNA-containing nanoparticle delivery to tumors

Toshiba’s new V-TRACE MRA for brain imaging

iMDsoft's MetaVision suite of solutions to be distributed by Dominion in Spain

ATS Medical receives Canadian approval for commercialization of Simulus Annuloplasty Product Line

Aston University scientists receive grants to develop new forms of drug delivery

ILSI Biomed Israel 2010 international conference to be held in Tel Aviv

Asuragen appoints BMD as exclusive distributor of Signature Oncology Products in France

SRI International researchers to disclose preliminary results of NTD detecting diagnostic at 239th ACS

Given Imaging to purchase Sierra Scientific Instruments from Water Street Healthcare Partners for $35M

FDA advisory panel recommends approval for Boston Scientific's CRT-D in treatment of mild heart failure

AAHRPP re-accredits BRI

Portable ultrasound device to treat chronic joint pain from arthritis

New device detects bacterial and fungal contamination

Dartmouth-Hitchcock Medical Center awarded ECRI Institute Health Devices Achievement Award

EUREKA project develops unique range of antibodies

ITDS can be effective for screening fever during H1N1 influenza pandemic: UNMC researchers

FDA panel favors approval with conditions of Medtronic's Revo MRI SureScan pacing system

Real-time Raman monitoring for pharmaceutical hot melt extrusion

Synthetic Psychedelics: A Growing Public Health Concern

How the Vutara VXL simplifies single-molecule imaging

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