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The U.S. Attorney’s Office for the Southern District of New York has indicted Laura Perryman, former CEO of Stimwave, a Florida-based medical device company, in connection with an alleged scheme for creating and selling a non-functioning medical device for implantation into patients suffering from chronic pain.
Baxter International announced that it issued an urgent medical device correction for potential patient oxygen desaturation, or low blood oxygen, under certain conditions when its Life2000 ventilation system is connected to a third-party oxygen concentrator.
The FDA has issued its first two replacement guidances — on face masks and face shields — of the 72 COVID-19-era guidances that automatically sunset after the expiration of the public health emergency on May 11.
The FDA has announced that when the COVID-19 public health emergency declaration expires on May 11, many of the 72 guidances issued to address the pandemic and that are still in effect will be revised and remain in effect, while others will be allowed to expire.
The Biden administration has asked Congress for $7.2 billion in funding for the FDA for fiscal 2024 — an approximately 10 percent increase over what the agency received in fiscal 2023.
The FDA has released a final rule that updates the agency’s mammography regulations to address changes in technology and strengthen the FDA’s oversight of mammography facilities.
Responding to FDA Commissioner Robert Califf’s recent remarks regarding the value of advisory committee (AdComm) votes, two major industry advocates offered slightly different takes on the question.
The Council of the European Union voted on Tuesday to adopt the proposal from its Commission for Health and Food Safety to delay implementation of the EU Medical Device Regulation.
The FDA updated its Sept. 8, 2022, safety communication to report on 19 published cases of squamous cell carcinoma (SCC) skin cancer and various lymphomas in the capsule that forms around breast implants, three of which were reported to result in patient deaths.
The FDA says more testing and analysis is needed to determine the risk of exposure to toxic compounds from tubing used in any hemodialysis or peritoneal dialysis system that has parts made of chlorinated peroxide cured silicone.