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FDA Requires Sybaritic to Stop Producing Unapproved Medical Devices

Sat, 09 Jan 2010 03:00:08 +0100

Sybaritic Inc., a medical device maker, has agreed to stop producing and distributing its medical products used in laser surgery (Dictionary/Medical-Dictionary/Laser-Surgery/), dermatology, and spa treatments until it is in compliance with FDA quality standards. The products are considered to be unapproved medical devices as they lack appropriate FDA clearance review and approval for safety and effectiveness. The agreement was part of a consent decree of injunction signed by Bloomington, Minn., company and three of its top executives, Anthony S. Daffer, Steven J. Daffer, and Ronald Berglund.



Treatment for Major Depression

Wed, 06 Jan 2010 03:00:08 +0100

Overall, only about half of Americans diagnosed with major depression (Dictionary/Medical-Dictionary/Depression/) in a given year receive treatment for it, and even fewer—about one fifth—receive treatment consistent with current practice guidelines, according to data from nationally representative surveys supported by NIMH. Among the ethnic/racial groups surveyed, African Americans and Mexican Americans had the lowest rates of use of depression care; all groups reported higher use of past-year psychotherapy vs. medication for depression.



Hereditary Factors Contribute to Aneurysm Formation in Twins

Tue, 05 Jan 2010 03:00:03 +0100

A new study in the January issue of the Journal of Vascular Surgery®, published by the Society for Vascular Surgery®, reveals robust epidemiological evidence that hereditary factors contribute to aneurysm formation in twins.



Safety of Medications Taken During Pregnancy

Thu, 31 Dec 2009 03:00:09 +0100

FDA, Health Organizations to Study Safety of Medications Taken During Pregnancy New collaborative research program to study effects on mothers and their babies A new research program called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) will fund research to study the effects of prescription medications used during pregnancy. The program is a collaboration among the U.S. Food and Drug Administration and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.



FDA Warns Public of Continued Extortion Scam by FDA Impersonators

Wed, 30 Dec 2009 03:00:09 +0100

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of an international extortion scam. The criminals call the victims -- who in most cases previously purchased drugs over the Internet or via telepharmacies -- and identify themselves as FDA special agents or other law enforcement officials. The criminals inform the victims that purchasing drugs over the Internet or the telephone is illegal, and that law enforcement action will be pursued unless a fine or fee ranging from $100 to $250,000 is paid. Victims often also have fraudulent transactions placed against their credit cards.



Runaway Vigilance Hormone Linked to Panic Attacks

Wed, 30 Dec 2009 03:00:08 +0100

A study has linked panic disorder (Dictionary/Medical-Dictionary/Panic-Disorder/) to a wayward hormone in a brain circuit that regulates vigilance. While too little of the hormone, called orexin, is known to underlie narcolepsy (http://www.nih.gov/news/health/may2009/ninds-03.htm), the new study suggests that too much of it may lead to panic attacks that afflict 6 million American adults.



FDA Approves A High Dose Seasonal Influenza Vaccine

Fri, 25 Dec 2009 03:00:09 +0100

The U.S. Food and Drug Administration today approved Fluzone High-Dose, an inactivated influenza virus vaccine for people ages 65 years and older to prevent disease caused by influenza virus subtypes A and B. People in this age group are at highest risk for seasonal influenza complications, which may result in hospitalization and death. Annual vaccination remains the best protection from influenza, particularly for people 65 and older.



U.S. Senate passes health care reform bill

Thu, 24 Dec 2009 10:42:22 +0100

Dec. 23, 2009: The U.S. Senate passed its version of health care reform legislation. The House and Senate bills now go to joint conference committee for negotiations to try to craft is a single bill from two very different bills. Source: WhiteHouse.gov (http://www.whitehouse.gov/blog/2009/12/24/another-tremendous-step-forward).



National Survey Tracks Rates of Common Mental Disorders Among American Youth

Tue, 15 Dec 2009 03:00:07 +0100

Only about half of American children and teenagers who have certain mental disorders receive professional services, according to a nationally representative survey funded in part by the National Institute of Mental Health (NIMH). The survey also provides a comprehensive look at the prevalence of common mental disorders.



Non-Invasive Technique Blocks a Conditioned Fear in Humans

Tue, 15 Dec 2009 03:00:07 +0100

Scientists have for the first time selectively blocked a conditioned fear memory in humans with a behavioral manipulation. Participants remained free of the fear memory for at least a year. The research builds on emerging evidence from animal studies that reactivating an emotional memory opens a 6-hour window of opportunity in which a training procedure can alter it.



Non-surgical Method for Diagnosing Breast Cancer

Tue, 15 Dec 2009 03:00:05 +0100

Press Release Date: December 14, 2009 Some methods of minimally invasive biopsy for breast cancer (Dictionary/Medical-Dictionary/Breast-Cancer-Pathologic-TNM-Finding/) are nearly as accurate as surgical biopsy but have much less risk of harms, according to a new report funded by HHS' Agency for Healthcare Research and Quality (AHRQ).



Behavioral Training Improves Connectivity

Thu, 10 Dec 2009 03:00:07 +0100

Children with poor reading skills who underwent an intensive, six-month training program to improve their reading ability showed increased connectivity in a particular brain region, in addition to making significant gains in reading, according to a study funded in part by the National Institute of Mental Health (NIMH). The study was published in the Dec. 10, 2009, issue of Neuron.



Non-Invasive Technique Blocks a Conditioned Fear

Thu, 10 Dec 2009 03:00:07 +0100

Scientists have for the first time selectively blocked a conditioned fear memory in humans with a behavioral manipulation. Participants remained free of the fear memory for at least a year. The research builds on emerging evidence from animal studies that reactivating an emotional memory opens a 6-hour window of opportunity in which a training procedure can alter it.



Major Databases Link Up to Advance Autism Research

Wed, 09 Dec 2009 03:00:08 +0100

Researchers studying autism spectrum disorders (ASD) will soon have access to a vast range of data and research tools through the NIH National Database for Autism Research (NDAR) (http://ndar.nih.gov/). Different labs often collect the same kinds of data. But they are often described differently, making it difficult to pool those data in any meaningful way. The NDAR research portal was designed to specifically address these differences by providing tools to define and standardize the complex data landscape that characterizes ASD research.



Norovirus Illnesses Linked to Oysters

Mon, 07 Dec 2009 03:00:08 +0100

The U.S. Food and Drug Administration is advising consumers to avoid eating oysters harvested from the San Antonio Bay on or after Nov. 16 due to reports of norovirus-associated illnesses in some people who had consumed oysters harvested from this area, which is located on the Gulf of Texas.