U.S. FOOD AND DRUG ADMINISTRATION: CELLDYN Emerald Class 2 Device Recall
Class 2 Device Recall CELLDYN Emerald
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U.S. FOOD AND DRUG ADMINISTRATION: PalTop Class 2 Device Recall
Class 2 Device Recall PalTop
FDA seeks to reform clinical trials
SILVER SPRING, Md. -- The Food and Drug Administration (FDA) wants to overhaul the current clinical trial process by giving patients, doctors and researchers clearer access to clinical trial information, according to a new FDA statement released by former FDA Commissioner Dr. Scott Gottleib, current FDA director of the Center for Devices and Radiological Health, Dr. Jeff Shuren, and current chief of staff to the FDA commissioner, Lauren Silvis.
Natural Cycles contraception app gets final FDA clearance
This month the U.S. Food and Drug Administration took the final steps in clearing the first family-planning app approved for use in the U.S.
U.S. FOOD AND DRUG ADMINISTRATION: FilterFlow Suction Handle
Class 2 Device Recall FilterFlow Suction Handle
U.S. FOOD AND DRUG ADMINISTRATION: Nelaton Urinary Catheter Class 2 Device Recall
Class 2 Device Recall Nelaton Urinary Catheter
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U.S. FOOD AND DRUG ADMINISTRATION: FDA approves first treatment for post-partum depression
The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.
U.S. FOOD AND DRUG ADMINISTRATION: Gentrix Surgical Matrix Thick
Class 2 Device Recall Gentrix Surgical Matrix Thick
Israeli device for treating Alzheimer's moves slowly through FDA-approval process for use in U.S.
An Israeli company is still working to get a medical device it says treats and potentially cures Alzheimer’s disease to be approved for use in the United States.