Risk Management: Page 10

Final 510(k) approvals for December 2000
Issued January 5, 2001
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 December 2000.
January 4, 2001
Imaging Diagnostic continues approval process for CT laser mammography
By AuntMinnie.com staff writers
January 2, 2001
Clinton signs bill to establish national imaging institute
By Eric Barnes
President Clinton has signed a bill to establish the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health, bringing a happy end to the lengthy saga of H.R. 1795.
December 28, 2000
Clinton signs telemedicine legislation
By AuntMinnie.com staff writers
December 27, 2000
ARRT to adopt MQSA mammography standards
By AuntMinnie.com staff writers
December 26, 2000
Guidant seeks FDA approval for intravascular radiotherapy system
By AuntMinnie.com staff writers
December 21, 2000
E-mail the White House
December 18, 2000
Imaging institute drive goes down to wire
By Eric Barnes
The U.S. Congress has passed legislation to establish a National Institute of Biomedical Imaging and Bioengineering by unanimous voice vote. The bill now awaits the signature of President Clinton, who, barring last-minute opposition from the NIH, is expected to sign it within the next several days.
December 18, 2000
HCFA broadens Medicare coverage for PET
By Eric Barnes
It's only December 18, but the nuclear medicine community has already received a new PET for Christmas. On Friday the U.S. Health Care Financing Agency (HCFA) announced greatly expanded Medicare coverage of PET imaging, giving doctors more leeway in determining how and when the use of PET would improve patient care.
December 17, 2000
Medicare to cover Endocare's cryosurgery prostate cancer treatment
By AuntMinnie.com staff writers
December 12, 2000
FDA Guidance on submitting a 510(k) for wireless telemetry medical devices
Issued December 12, 2000
This document provides direction to manufacturers on deciding when to submit a 510(k) for a change to their existing wireless telemetry medical device or to a medical device incorporating wireless telemetry as a feature.
December 11, 2000
Final PMA approvals for November 2000
Issued December 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 November 2000.
December 11, 2000
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