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FDA's approval time for medical devices increases

According to MassDevice.com, the online business journal of the medical device industry, medical device approval times under the Food & Drug Administration's 510(k) clearance process jumped 30 percent between 2005 and 2008. MassDevice's exclusive investigation of 10 years of FDA data, Eye on the FDA: H1 2009, shows that approval times for medical devices increased nearly 2 percent — while the number of 510(k) applications declined more than 19 percent — even as the FDA's budgets and staff levels rose.

7 Nov 2009

FDA extends review date of New Drug Application for GSK1838262/XP13512

GlaxoSmithKline and XenoPort, Inc. (Nasdaq: XNPT) today announced that the U.S. Food and Drug Administration (FDA) has extended the original Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) for GSK1838262/XP13512 (gabapentin enacarbil) to February 9, 2010. The original PDUFA date for this NDA review was November 9, 2009.

7 Nov 2009

Current health care debate in the United States complicated

The current health care debate in the United States is complicated. Trade-offs between heath care expenditures, lifestyle choices and life expectancy have been suggested but seldom clearly demonstrated.

7 Nov 2009

PET scanning emerges as an important tool in the evaluation of lung cancer

A rapid decline in metabolic activity on a PET scan after radiation therapy for non-small cell lung cancer is correlated with good local tumor control, according to a study presented by researchers at Thomas Jefferson University Hospital at the 51st ASTRO Annual Meeting.

7 Nov 2009

Seminar highlights the importance of chronic health issues

With 125 million Americans challenged by at least one chronic illness and 22% of that number facing life with two or more chronic illnesses, early, smart estate and financial planning can make the difference between maximizing control over your life or falling victim to its exigencies.

7 Nov 2009

Report provides critical strategic insight for companies with a stake in the market for rheumatology therapies

MedPredict Market Research, a global provider of pharmaceutical competitive intelligence and market research, has published a new report providing critical strategic insight for companies with a stake in the market for rheumatology therapies, including rheumatoid arthritis (RA) and lupus.

7 Nov 2009

Speaker Pelosi comments on Congressman Anthony Weiner's single payer alternative

While our bill contains unprecedented reforms, including an end to discrimination for pre-existing conditions and a prohibition on raising rates or dropping coverage if you become ill, our bill cannot include provisions some strongly advocated. The single payer alternative is one of those provisions that could not be included in H.R. 3962, but which has generated support within the Congress and throughout the country.

7 Nov 2009

Human fetuses become active listeners in the last trimester of the pregnancy: Study

In the first days of their lives, French infants already cry in a different way to German babies. This was the result of a study by researchers from the Max Planck Institute for Human Cognitive and Brain Sciences in Leipzig, the Centre for Pre-language Development and Developmental Disorders (ZVES) at the University Clinic W-rzburg, and the Laboratory of Cognitive Sciences and Linguistics at the Ecole Normale Sup-rieure in Paris.

7 Nov 2009

Experts applaud the EU Presidency for establishing a transatlantic task force to address antibiotic resistance

Experts on both sides of the Atlantic applaud President Barack Obama and Swedish Prime Minister Fredrik Reinfeldt, representing the European Union (EU) Presidency, for establishing a transatlantic task force to address antibiotic resistance, an urgent and growing problem that threatens patient safety and public health worldwide.

7 Nov 2009

Winner of the 2009 Women in Cardiology Mentoring Award

C. Noel Bairey Merz, M.D., an internationally recognized authority on women's heart health, will receive the American Heart Association's 2009 Women in Cardiology Mentoring Award at the organization's Scientific Sessions 2009, to be held in Orlando at the Orange County Convention Center Nov. 14-Nov. 18.

7 Nov 2009

Obama goes back on his 2008 pledge, endorses healthcare bill raising taxes on families making less than $250,000 per year

By formally endorsing the House healthcare bill today, President Barack Obama effectively announced that the central promise of his 2008 campaign was a lie.

7 Nov 2009

2009 H1N1 influenza PPE federal guidance for healthcare workers causes concern among prevention experts

Three leading scientific organizations specializing in infectious diseases prevention issued a letter to President Obama today expressing their significant concern with current federal guidance concerning the use of personal protective equipment (PPE) by healthcare workers in treating suspected or confirmed cases of 2009 H1N1 influenza.

7 Nov 2009

Prestige Ameritech to open a Global Pandemic Preparedness and Response Center

Prestige Ameritech is turning a vacant, former Kimberly-Clark surgical mask factory into a Global Pandemic Preparedness and Response Center. The 220,000 square foot facility, on 17 acres in North Richland Hills, Texas, will open by January 31, 2010.

7 Nov 2009

Health care leaders to address the value of collaboration and challenges inherent to interoperability

A panel of executives representing public-sector health, health care providers, health care information technology, and health plans will address the value of collaboration and the challenges inherent to interoperability, especially as both topics pertain to health information networks.

7 Nov 2009

Hoyer says House health vote could be delayed

"House Majority Leader Steny Hoyer (D-Md.) said 'delay tactics' could prevent the vote from occurring at the 6 p.m. Saturday scheduled time," and "suggested the debate could go into Sunday or next week," The Hill reports.

7 Nov 2009

SNM commends the U.S. House of Representatives for its passage of medical isotope legislation

SNM applauds the U.S. House of Representatives for its passage of H.R. 3276-the American Medical Isotopes Production Act of 2009.

7 Nov 2009

Pediatrician recommends red reflex vision test for all newborns

With the number of premature births and medically fragile infants now increasing in the U.S., a basic eye exam, including a red reflex test, should be given to all children shortly after birth, reports Angela Buffenn, M.D., M.P.H., Director of the Orbit and Eye Movement Institute at The Vision Center of Childrens Hospital Los Angeles.

7 Nov 2009

NHLBI stops enrollment in study comparing resuscitation strategies

Enrollment has ended early in a large, multicenter clinical trial comparing two distinct resuscitation strategies delivered by emergency medical service (EMS) providers to increase blood flow during cardiac arrest. The study's independent monitoring board and the National Heart, Lung, and Blood Institute (NHLBI), the lead sponsor of the study, stopped enrollment based on preliminary data suggesting that neither strategy significantly improved survival.

7 Nov 2009

Allied Healthcare Products sales declines 21% in the first quarter of fiscal year 2010

Recession in domestic and international markets continued to depress sales for Allied Healthcare Products in the first quarter of fiscal year 2010 ending September 30, 2009.

7 Nov 2009

San Francisco map of HIV viral loads shows where care lags

Researchers in San Francisco have identified how much virus people infected with HIV are carrying and mapped their results, which show that that AIDS treatment lags in certain neighborhoods. The work also showed that the sickest patients were often African-American, homeless and transgender.

7 Nov 2009

Medical News

FDA's approval time for medical devices increases

FDA extends review date of New Drug Application for GSK1838262/XP13512

Current health care debate in the United States complicated

PET scanning emerges as an important tool in the evaluation of lung cancer

Seminar highlights the importance of chronic health issues

Report provides critical strategic insight for companies with a stake in the market for rheumatology therapies

Speaker Pelosi comments on Congressman Anthony Weiner's single payer alternative

Human fetuses become active listeners in the last trimester of the pregnancy: Study

Experts applaud the EU Presidency for establishing a transatlantic task force to address antibiotic resistance

Winner of the 2009 Women in Cardiology Mentoring Award

Obama goes back on his 2008 pledge, endorses healthcare bill raising taxes on families making less than $250,000 per year

2009 H1N1 influenza PPE federal guidance for healthcare workers causes concern among prevention experts

Prestige Ameritech to open a Global Pandemic Preparedness and Response Center

Health care leaders to address the value of collaboration and challenges inherent to interoperability

Hoyer says House health vote could be delayed

SNM commends the U.S. House of Representatives for its passage of medical isotope legislation

Pediatrician recommends red reflex vision test for all newborns

NHLBI stops enrollment in study comparing resuscitation strategies

Allied Healthcare Products sales declines 21% in the first quarter of fiscal year 2010

San Francisco map of HIV viral loads shows where care lags

Evolving spectrophotometry for modern biopharma workflows

Scaling B-cell cloning workflows for antibody development

Fluidics in Modern Healthcare & Medical Device Innovation

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