Regulatory: Page 180

Cook files PMA for renal stent
By AuntMinnie.com staff writers
Interventional technology firm Cook Medical has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration for a balloon-expandable stent for renal artery disease.
September 23, 2010
FDA panel to review Hologic tomo unit
By AuntMinnie.com staff writers
An advisory panel of the U.S. Food and Drug Administration on September 24 is scheduled to review a regulatory application from Hologic for a 3D digital breast tomosynthesis mammography system.
September 22, 2010
FDA, CMS propose parallel product review
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are considering a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to a parallel review.
September 19, 2010
New FDA policy has changes for all gadolinium MRI agents
By James Brice
The revised labeling policy issued by the U.S. Food and Drug Administration last week appeared to zero in on Omniscan, Magnevist, and Optimark as the key suspects in the occurrence of nephrogenic systemic fibrosis, but the new rules also modify requirements for four other gadolinium-based contrast agents.
September 15, 2010
U.S. health spending to hit $4.6 trillion by 2019
By AuntMinnie.com staff writers
U.S. health spending is expected to grow at an average annual rate of 6.3% in the next 10 years, reaching $4.6 trillion in 2019, according to a report from the U.S. Centers for Medicare and Medicaid Services published online September 9 in Health Affairs.
September 14, 2010
FDA raises medical device user fees
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration (FDA) plans to increase its medical device user fees by 8.5%, effective October 1.
September 13, 2010
Indicted Ga. technologist surrenders to authorities
By Kate Madden Yee
A radiologic technologist charged with submitting false mammogram results during her tenure at a Georgia hospital has turned herself in and is being held without bond at the Houston County, GA, detention center.
September 13, 2010
U-Systems somo.v nets EU clearance
By AuntMinnie.com staff writers
Ultrasound developer U-Systems has received approval to market its somo.v automated breast ultrasound system as an adjunct to mammography for screening asymptomatic women for breast cancer in the European Union.
September 12, 2010
FDA updates warning labels on gadolinium contrast
By AuntMinnie.com staff writers
The U.S. Food and Drug Administration today announced that it is updating the warning labels required on three gadolinium-based MRI contrast agents sold in the U.S. due to the risk of nephrogenic systemic fibrosis.
September 8, 2010
Technologist indicted over false mammo results
By Kate Madden Yee
A radiologic technologist at a Georgia hospital has been indicted on 20 charges of submitting false mammogram results by marking mammography studies as completed even though they hadn't been reviewed by a physician.
September 8, 2010
Mayo says 3K patients at risk in hep C scandal
By Eric Barnes
The Mayo Clinic in Jacksonville, FL, said that more than 3,200 patients may have been put at risk by an interventional radiologic technologist who has been fired. The employee has admitted to stealing drugs and contaminating needles used for injectable pain medications before administering drugs to patients, Mayo said.
September 2, 2010
FDA: No. of mammo sites drops again
By AuntMinnie.com staff writers
The number of mammography facilities accredited by the U.S. Food and Drug Administration continued its slow decline in the FDA's most recent reporting period.
September 1, 2010
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