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FDA Launches AccessGUDID, a Database to Track Devices
The database will allow consumers, healthcare providers, and product manufacturers to access information tracked on medical devices, with the end goal of improving patient safety, improving device postmarket surveillance, and facilitating medical device innovation.
The FDA launched an eagerly-anticipated database to allow consumers, healthcare providers and product manufacturers to access information tracked on medical devices.
The online Global Unique Device Identification Database, called AccessGUDID, follows almost 3 years after Congress mandated that medical devices be marked and tracked with unique identifiers. FDA’s database uses a unique device identification system to identify devices sold in the US, with the capability to track them from manufacturing through distribution to patient use, the FDA said.
When fully implemented, the label of most devices will include a UDI in human- and machine-readable form. Device labelers must also submit certain information about each device to AccessGUDID, where the public can search and download information.
Read the article on Governement HealthIT: http://bit.ly/1ctcAlM
POSITIVE Trial Update on Patients With Breast Cancer Attempting Pregnancy
December 8th 2023At last year’s San Antonio Breast Cancer Symposium, POSITIVE trial primary outcome data were presented on breast cancer–free interval, with women who paused endocrine therapy to attempt pregnancy having a similarly small rate of recurrence vs external controls from the SOFT and TEXT trials: 8.9% vs 9.2%.
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Emily Goldberg Shares Insights as a Genetic Counselor for Breast Cancer Risk Screening
October 30th 2023On this episode of Managed Care Cast, Emily Goldberg, MS, CGC, a genetic counselor at JScreen, breaks down how genetic screening for breast cancer works and why it is so important to increase awareness and education around these screening tools available to patients who may be at risk for cancer.
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