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FDA grants Fenwal 510(k) clearance for Amicus separator with DXT

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced today the U.S. Food and Drug Administration has granted Fenwal 510(k) clearance for its Amicus® separator with new wireless data-export capabilities.

29 Apr 2010

Xlumena receives FDA clearance to market NAVIX Access Device

Xlumena, a privately held provider of innovative technology for gastroenterologists/interventional endoscopists, today announced it has received clearance from the US Food and Drug Administration to market its NAVIX Access Device.

28 Apr 2010

Sinai Medical Group to deploy NextGen EHR and NextGen Practice Management system

NextGen Healthcare Information Systems, Inc., a wholly owned subsidiary of Quality Systems, Inc. and leading provider of healthcare information systems and connectivity solutions, today announced it has executed an agreement with Sinai Medical Group to deploy NextGen EHR and NextGen Practice Management.

28 Apr 2010

Wellstar International to install TMI Imaging system in Beverly Hills

Wellstar International Inc. has announced they will be installing a system in Beverly Hills, California.

28 Apr 2010

Cancer-related expenditures increase faster than any other area of health care: JAMA

From 1999 through 2006 the use of diagnostic imaging for Medicare patients with cancer increased, with use of positron emission tomography increasing the most significantly, according to a study in the April 28 issue of JAMA. Imaging costs for these patients also increased, outpacing the rate of increase in total costs among Medicare beneficiaries with cancer.

28 Apr 2010

Maryland startup Rhemisphere signs agreement with UMB for right to commercialize Blink system

Maryland startup Rhemisphere, LLC has licensed a unique, "all-in-one" patient monitoring system invented by clinical researchers at the University of Maryland, Baltimore.

28 Apr 2010

Volcano to distribute AngioSculpt PTCA Scoring Balloon Catheter in Japan

Volcano Corporation, a leading developer and manufacturer of precision intravascular therapy guidance tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced today that it has entered into a distribution agreement with AngioScore for its AngioSculpt® PTCA Scoring Balloon Catheter for coronary indications in Japan. This is the first of what Volcano believes will be many products distributed by Volcano Japan, which now includes more than 50 direct sales representatives.

28 Apr 2010

Researchers develop new diagnostic approach to fight against Chagas disease

Chagas disease is one of the most deadly parasitic diseases in the world. It affects more than 10 million people, primarily in the Americas. In South America alone it kills 50 000 people each year. A reliable and rapid diagnosis is the key in the battle against infection but until now, this has been next to impossible.

28 Apr 2010

Myriad Genetics OnDose collection kit eliminates need for frozen sample handling

Myriad Genetics, Inc. today announced a significant improvement in the sample collection kit for OnDoseTM, its 5-Fluorouracil (5-FU) dose optimization product. Patient sample handling can now be conducted at room temperature, eliminating the need for frozen sample handling. Myriad said that it believes the simplified process should increase physician acceptance and utilization of OnDose.

28 Apr 2010

Master's programs focus on new generation of health care management professionals

Health care management is growing in popularity among business schools, according to a report in the New York Times. "Health care is the target career for 10 percent of students working on a master of business administration degree at Harvard Business School," according to the Times. Many other universities are also highlighting programs that meld health care and management.

28 Apr 2010

FDA issues warning over faulty components in external defibrillators

About 280,000 external defibrillators used worldwide in health care facilities, public places, or in the home may malfunction during attempts to rescue people in sudden cardiac arrest, the U.S. Food and Drug Administration warned today.

28 Apr 2010

Study results from US Military Malaria Vaccine Program announced

Bioject Medical Technologies Inc., a leading developer of needle-free injection therapy systems, today announced that the US Military Malaria Vaccine Program presented results of its study using the Biojector2000 with a recombinant DNA vaccine at two recent conferences. A Cooperative Research and Development Agreement was signed with the Navy in April 2009 to work together on the study.

28 Apr 2010

Boston-Power announces lithium-ion battery technology for medical device and equipment market

Boston-Power®, Inc., the rapidly growing provider of next-generation lithium-ion batteries, is responding to strong customer and partner demand by bringing its industry-leading lithium-ion battery technology to the multi-billion dollar global medical device and equipment market. Boston-Power's lithium-ion battery cells deliver unmatched levels of long life, fast charge and safety to a market that demands the most stringent standards of battery reliability to ensure that patients receive the highest quality of care.

28 Apr 2010

Tel Aviv University researcher pioneers 3-D occupational therapy for children with disabilities

It was her love of ballet that led her to work with children who have motor disabilities. The retired dancer, now an occupational therapist, is pioneering a new "virtual" method to analyze movement patterns in children ― and more effectively treat those with debilitating motor disorders.

28 Apr 2010

Five-minute screening test could cut risk of developing bowel cancer: Research

A five-minute screening test could cut the risk of developing bowel cancer by a third and save thousands of lives from what is the UK's second biggest cancer killer, according to new research led by Imperial College London, published today in the Lancet.

28 Apr 2010

'Flexi-Scope' test reduces incidence of bowel cancer

A one-off screening test that takes just five minutes could reduce the risk of bowel cancer by one-third and save thousands of lives, UK scientists have said.

28 Apr 2010

SI-BONE to present iFuse MIS procedure at WCMISST 2010

SI-BONE, Inc., a medical device company that is pioneering the use of a minimally invasive surgical device to treat the sacroiliac joint today announced that iFuse initial post-market clinical experience will be presented at upcoming 2010 minimally invasive spine surgery meetings.

28 Apr 2010

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

The U.S. Food and Drug Administration today approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults.

28 Apr 2010

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

Cardiovascular Systems, Inc., has received Food and Drug Administration unconditional Investigational Device Exemption (IDE) approval, allowing the company to proceed with ORBIT II, a pivotal trial to evaluate the safety and effectiveness of CSI's Diamondback 360® System in the coronary arteries. CSI received conditional IDE approval for the ORBIT II study in January 2010.

28 Apr 2010

BioMedix TRAKnet software suite receives APMA Seal of Acceptance

Today, the BioMedix TRAKnet software suite was granted the prestigious American Podiatric Medical Association (APMA) Seal of Acceptance. BioMedix is the only company to receive the APMA Seal of Acceptance for Electronic Health Record and Practice Management software.

28 Apr 2010

Device / Technology News

FDA grants Fenwal 510(k) clearance for Amicus separator with DXT

Xlumena receives FDA clearance to market NAVIX Access Device

Sinai Medical Group to deploy NextGen EHR and NextGen Practice Management system

Wellstar International to install TMI Imaging system in Beverly Hills

Cancer-related expenditures increase faster than any other area of health care: JAMA

Maryland startup Rhemisphere signs agreement with UMB for right to commercialize Blink system

Volcano to distribute AngioSculpt PTCA Scoring Balloon Catheter in Japan

Researchers develop new diagnostic approach to fight against Chagas disease

Myriad Genetics OnDose collection kit eliminates need for frozen sample handling

Master's programs focus on new generation of health care management professionals

FDA issues warning over faulty components in external defibrillators

Study results from US Military Malaria Vaccine Program announced

Boston-Power announces lithium-ion battery technology for medical device and equipment market

Tel Aviv University researcher pioneers 3-D occupational therapy for children with disabilities

Five-minute screening test could cut risk of developing bowel cancer: Research

'Flexi-Scope' test reduces incidence of bowel cancer

SI-BONE to present iFuse MIS procedure at WCMISST 2010

Alair Bronchial Thermoplasty System receives FDA approval to treat asthma in adults

CSI granted FDA unconditional IDE approval for trial of Diamondback 360 System in coronary arteries

BioMedix TRAKnet software suite receives APMA Seal of Acceptance

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