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State Update: User Fee Relief in Massachusetts
FDAnews - Sunday, August 13, 2006
Massachusetts Gov. Mitt Romney July 8 signed a budget bill into law that includs a state tax credit for payment of FDA device user fees, the Massachusetts Medical Device Industry Council (MassMEDIC) announced in its July 2006 ... more

Dental Devicemaker Cited for cGMP Violations
FDAnews - Sunday, August 13, 2006
A manufacturer of dental scalers and dental accessories, including inserts, hand pieces and foot switches, received a July 17 FDA warning letter saying the devices are adulterated and misbranded because of a number of current good manufacturing practice (cGMP) ... more

CMS Responds to Lawmakers on Proposed Payment System Changes
FDAnews - Sunday, August 13, 2006
Centers for Medicare & Medicaid Services (CMS) Administrator Mark McClellan July 20 addressed the opposition his agency has seen to its proposals to change the Medicare inpatient prospective payment system in ... more

Briefs
FDAnews - Sunday, August 13, 2006
... more

Device Recalls
FDAnews - Sunday, August 13, 2006
... more

DESPITE SHORT-TERM COSTS, GUIDANT ACQUISITION SEEN AS BOON TO ABBOTT
FDAnews - Sunday, August 13, 2006
Analysts are projecting a sunny outlook for Abbott Laboratories based on 2006 second-quarter results ? despite some company ... more

EDITORIAL: COSTLY TECHNOLOGY NOT 'ENEMY' OF HEALTHCARE SYSTEM
FDAnews - Sunday, August 13, 2006
Illness, injury and disease" are the real "enemies" of the healthcare system, and not the cost of medical technology innovation, said one health expert in response to a July 20 article in the Pioneer Press on what some are calling a "medical arms ... more

PATENT LITIGATION WITH ROCHE RESOLVED, BIOSITE SAYS
FDAnews - Sunday, August 13, 2006
Biosite July 26 said it has resolved all outstanding patent litigation with Roche Diagnostics and several of that firm's ... more

SIEMENS CLOSES ACQUISITION OF DIAGNOSTIC PRODUCTS
FDAnews - Sunday, August 13, 2006
Siemens AG said Thursday it has completed its acquisition of Diagnostic Products Corp. for $1.86 billion, or $58.50 a ... more

TRIE MEDICAL'S PRODUCT LINE IMPROVES STANDARD OF LAB TESTING FOR METERED DOSE INHALERS
FDAnews - Sunday, August 13, 2006
TriE Medical, Inc., a privately held medical device development company, has developed a shake/fire system for the testing of metered dose inhalers, to be used as a research tool, formulation device, and to collect regulatory submission data for verification and validation ... more


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UNIQUE EPILEPSY TREATMENT; "BRAIN PACEMAKER" DESIGNED AS EXTERNAL OR IMPLANT DEVICE
FDAnews - Sunday, August 13, 2006
A unique nerve-stimulation treatment for epilepsy developed at UCLA offers a potential new alternative for tens of thousands of individuals unable to control their seizures with medication and ineligible for ... more

BIOPROGRESS GETS REGISTRATION FOR HYPOSALIX SPRAY AS A MEDICAL DEVICE
FDAnews - Sunday, August 13, 2006
BioProgress PLC, the speciality pharmaceutical and healthcare company, said it has obtained registration for its Hyposalix spray for dry mouth as a medical device, and plans to launch the product in the EU within six ... more

FDA APPROVES NEW TEST FOR SCREENING INFECTION IN BABIES
FDAnews - Sunday, August 13, 2006
A new test that screens babies for the presence of a common infection was approved by the Food and Drug Administration on ... more

SURGICAL TOOL TRADE ETHICS FEARS
FDAnews - Sunday, August 13, 2006
The purchase of surgical equipment should be bound by the same fair trade rules as foodstuffs like coffee, sugar or bananas, a researcher ... more

Benin Bans Harassment; U.S. Ignores Workers' Abuse
Topix - Sunday, August 13, 2006
The Republic of Benin's National Assembly voted July 17 to pass the country's first comprehensive sexual harassment legislation aimed at protecting girls and women in schools, workplaces and in homes, according ... ... more

Motorbike Taxis in Drive to Get Girls Into School
allAfrica.com - Sunday, August 13, 2006
As Beninese school-children begin their annual break, the country's iconic motorbike taxis, or "Zemidjans", are joining a national drive to get all girls into ... more

MANUFACTURER IMPLANTED DEVICES WITHOUT WRITTEN CONSENT, FDA SAYS
FDAnews - Sunday, August 13, 2006
Galesburg Orthopedic Services did not obtain written consent from patients before implanting its devices, nor did it obtain FDA and institutional review board (IRB) approval before allowing patients to participate in clinical trials, the FDA said in a recent warning ... more

DEVICE, DRUG INDUSTRY EXCLUDED FROM ANTI-KICKBACK SAFE HARBOR
FDAnews - Sunday, August 13, 2006
HHS is excluding device and drugmakers from a new protection from the anti-kickback statute designed to promote adoption of electronic health records, arguing that these sectors cannot be trusted to abide by the ... more

CMS PROPOSES RULE ON PAYMENTS FOR HOME-USE OXYGEN EQUIPMENT
FDAnews - Sunday, August 13, 2006
The Centers for Medicare & Medicaid Services (CMS) recently proposed payment changes for home-use oxygen equipment, oxygen contents and capped rental durable medical ... more

THERMOGENESIS CORP. SIGNS AGREEMENT WITH BIOMET BIOLOGICS, INC. TO PRODUCE INTRA-OPERATIVE AUTOLOGOUS FIBRIN SEALANT
FDAnews - Sunday, August 13, 2006
ThermoGenesis Corp. announced that the Company entered into a development, license and supply agreement with Biomet Biologics, Inc., a wholly owned subsidiary of Biomet, ... more

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