Regulatory: Page 281

Final 510(k) decisions for October 2002
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 October 2002.
October 3, 2002
FDA public health notification: Cochlear implant recipients at greater risk for meningitis
The Food and Drug Administration (FDA) has become aware of a possible association between cochlear implants and the occurrence of bacterial meningitis.
October 3, 2002
Instrumentarium gets 510(k) clearance for digital mammo systems
By AuntMinnie.com staff writers
Mammography and x-ray firm Instrumentarium Imaging has received U.S. Food and Drug Administration 510(k) clearance to market its Delta 32 and Delta 32 TACT diagnostic digital breast imaging systems.
October 2, 2002
Hologic gets final approval for Selenia FFDM system
By AuntMinnie.com staff writers
Hologic of Bedford, MA, has received final Food and Drug Administration approval to sell its Lorad Selenia full-field digital mammography system in the U.S.
October 2, 2002
PET advocates urge CMS to rethink proposed reimbursement rates
By Kate Madden Yee
Less than six months after raising Medicare reimbursement rates for FDG-PET procedures, the Centers for Medicare and Medicaid Services (CMS) has recommended significantly lower rates for 2003, sparking a flurry of activity among PET proponents to educate CMS on the true cost of PET.
September 29, 2002
National Mammography Quality Assurance Advisory Committee
Issued September 24, 2002
The National Mammography Quality Assurance Advisory Committee has posted a transcript of its August 26, 2002 meeting held in Gaithersburg, MD.
September 23, 2002
Final 510(k) decisions for August 2002
Updated September 23, 2002
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 August 2002.
September 22, 2002
FDA Radiological Devices panel to discuss breast thermal imaging
Issued September 20, 2002
An October 16, 2002 meeting of the FDA Radiological Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations, and vote on a premarket approval application for a device that produces a computerized thermal image of the breast of women recommended for biopsy.
September 20, 2002
Theseus seeks FDA IND for new agent
By AuntMinnie.com staff writers
Theseus Imaging is submitting an investigational new drug application to the U.S. Food and Drug Administration next month for its Hynic-Annexin V product candidate.
September 16, 2002
IDSI installs CTLM in Berlin
By AuntMinnie.com staff writers
Laser breast imaging firm Imaging Diagnostic Systems has installed its CT Laser Mammography (CTLM) system at the Humboldt University of Berlin, Charité Hospital.
September 11, 2002
Final PMA approvals for August 2002
Issued September 10, 2002
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 August 2002.
September 9, 2002
Final 510(k) decisions for September 2002
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 2002.
September 5, 2002
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