[Posted 09/07/2016] AUDIENCE: Patient, OBGYN, Oncology ISSUE: The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer….
The FDA recommends against using screening tests for ovarian cancer screening: FDA Safety Communication
Date Issued: September 7, 2016 Audience: Women and physicians Medical Specialty: Primary care, Obstetrics and Gynecology, Oncology, Gynecologic Oncology, Genetic Counseling Purpose: The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women…
Transcript posted for August 16, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee meeting
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August 2016 PMA Approval List
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Class I Medical Device Recall: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination
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Mammography Facility Adverse Event and Action Report
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UDI Extension Letter to Device Labelers
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Essure
September 2015 Advisory Committee to discuss Essure Safety and Effectiveness The FDA has been examining safety concerns about Essure raised by patients and cited in Medical Device Reports (MDRs). We convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015 to: discuss currently available scientific…
Essure
September 2015 Advisory Committee to discuss Essure Safety and Effectiveness The FDA has been examining safety concerns about Essure raised by patients and cited in Medical Device Reports (MDRs). We convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015 to: discuss currently available scientific…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150049 added)
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