Risk Management: Page 15

Final PMA approvals for September, 2000
Issued October 12, 2000
Each month the U.S. food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions from the previous month. The following decisions were rendered for September 2000.
October 11, 2000
Fonar wins FDA nod for new scanner
By AuntMinnie.com staff writers
October 11, 2000
Final 510(k) approvals for September 2000
Issued October 5, 2000
Each month the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH) releases a final list of devices approved for marketing in the U.S. during the previous month. The following is a list of 510(k) final decisions rendered for September, 2000.
October 5, 2000
Bill to modify physician referral law dropped for now
By AuntMinnie.com staff writers
October 3, 2000
Bill to weaken physician self-referral ban is introduced
By AuntMinnie.com staff writers
October 2, 2000
Academy issues call for support of imaging institute
By AuntMinnie.com staff writers
October 1, 2000
CDRH announces advisory meeting on Nov. 6, 2000
Issued September 28, 2000
The Food and Drug Administration's Center for Devices and Radiological Health (CDRH) will hold a public meeting on November 6, 2000 in Gaithersburg, MD, U.S. The Radiological Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations, and vote on a premarket approval application for an embolic radiation therapy device.
September 27, 2000
Bill mandating technologist standards introduced in House
By Eric Barnes
A bill requiring states to set up licensing procedures for radiologic technologists was introduced September 25 in the U.S. House of Representatives. The CARE Act will require minimum educational and credentialing standards, both for radiation therapists, and for personnel who perform medical imaging exams.
September 27, 2000
Imaging institute bill passes U.S. House; heads for Senate
By Eric Barnes
U.S. radiologists got the news they've been waiting for with yesterday's passage of H.R. 1795, a bill to establish an Institute of Biomedical Imaging and Bioengineering at the U.S. National Institutes of Health. The legislation now heads for the Senate, where it will likely face a vote in the next two weeks.
September 27, 2000
FDA approves OSI ultrasound scanner to assess fracture risk
By AuntMinnie.com staff writers
September 25, 2000
OIG audits are scary but survivable
By Jonathan S. Batchelor
When the Office of the U.S. Inspector General knocks on your door with a compliance audit, it pays to cooperate, says Judy Dye of the University of Arizona Medical Center. Dye should know. Her facility survived an audit; good planning and execution can save yours too, she says.
September 21, 2000
Biometrics comes of age as security takes center stage
By Eric Barnes
Medical data security covers everthing from the transmission, archiving, and distribution of information all the way to authentication -- making sure users are who they say they are. Biometric authentication isn't science fiction anymore. It's here, and it's starting to get noticed as security needs converge with rapid advances in technology.
September 18, 2000
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