Mehmet Oz, President Trump’s pick to lead the CMS, said Medicare beneficiaries should have quicker access to new medical ...
We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority ...
Medical Device Network on MSN11h
FDA approves early feasibility study of Valcare’s transcatheter deviceThe US Food and Drug Administration (FDA) has granted approval for Valcare Medical’s investigational device exemption application, allowing it to begin an early feasibility study of its transcatheter ...
Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...
Cheap, illegal imported vaping products from China have harmed young people in Tennessee. Stop illegal access, but keep regulated products available.
The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
The draft guidance addresses criticisms that pulse oximeters are less accurate for people with dark skin tones. Experts ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
Potential Medicare coverage reforms, such as eliminating Coverage with Evidence Development, would remove key policy tools ...
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