Regulatory: Page 183

FDA targets improvements to 510(k) process
By Erik L. Ridley
With an eye toward encouraging innovation, providing regulatory predictability, and ensuring patient safety, the U.S. Food and Drug Administration's Center for Devices and Radiological Health has issued two preliminary reports offering suggestions on how to improve the 510(k) program for medical devices.
August 3, 2010
Japan expands CyberKnife uses
By AuntMinnie.com staff writers
Radiation therapy firm Accuray has received approval from the Japanese Ministry of Health, Labor and Welfare to market its CyberKnife G4 robotic radiosurgery system in Japan to treat tumors noninvasively anywhere in the body, including the head and neck.
August 3, 2010
CMS to offer EHR education series
By AuntMinnie.com staff writers
The U.S. Centers for Medicare and Medicaid Services (CMS) will host a series of national provider calls to discuss the specifics of the Medicare and Medicaid electronic health record (EHR) incentive programs for hospitals and individual practitioners.
July 28, 2010
Final meaningful use rules: What radiologists need to know
By Cynthia E. Keen
On July 13, U.S. physicians and hospitals received their marching orders on how to receive federal incentive payments for adopting electronic medical records. But the question remains: What does this mean for radiology?
July 28, 2010
GE settles oil-for-food charges with SEC
By AuntMinnie.com staff writers
GE Healthcare has agreed to pay a $23.4 million settlement to the U.S. Securities and Exchange Commission (SEC) to settle charges that GE-related companies violated the rules of the United Nations oil-for-food program in Iraq earlier in the decade.
July 26, 2010
Hologic secures panel date for tomo PMA
By AuntMinnie.com staff writers
Women's healthcare vendor Hologic has received a date for review of its Selenia Dimensions 3D digital mammography tomosynthesis system by the U.S. Food and Drug Administration.
July 26, 2010
CMS unveils imaging decision-support initiative
By Cynthia E. Keen
The U.S. Centers for Medicare and Medicaid Services (CMS) has announced a $10 million project to evaluate the efficacy of decision-support systems for ordering diagnostic imaging studies.
July 22, 2010
Report: Senator delays isotope bill
By AuntMinnie.com staff writers
Sen. Christopher Bond (R-MO) reportedly continues to delay debate in the U.S. Congress on the American Medical Isotopes Production Act, asserting that the bill designed to promote the production of medical isotopes in the U.S. could have the opposite effect.
July 22, 2010
Relaxing rigid timing of linac safety tests may offer benefits
By Cynthia E. Keen
Emergency turnoff switches for radiation therapy equipment need to be tested regularly to maintain high quality standards. But a presentation made today at the American Association of Physicists in Medicine meeting suggests that some state regulations aren't necessarily based on safety facts.
July 21, 2010
Dutch regulators OK Petten restart
By AuntMinnie.com staff writers
Radiopharmaceutical producer Nuclear Research and Consultancy Group has received approval from Dutch regulators to resume service at its High Flux Reactor in Petten, the Netherlands.
July 20, 2010
FDA clears Fuji's FDR D-Evo
By AuntMinnie.com staff writers
Fujifilm Medical Systems USA has received 510(k) clearance from the U.S. Food and Drug Administration to market its FDR D-Evo flat-panel digital radiography cassette.
July 20, 2010
FDA probe prompts closure of Columbia PET laboratory
By Wayne Forrest
Columbia University Medical Center in New York City has suspended all activities at its Kreitchman PET Center laboratory following a four-year probe by the U.S. Food and Drug Administration.
July 19, 2010
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