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.

Abbott’s MitraClip cut the rate of hospitalizations while improving survival for heart failure patients with severe secondary mitral valve regurgitation (MR) in a five-year study at multiple U.S. medical centers.

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.