Neovasc (NSDQ:NVCN) announced that an FDA advisory panel voted against reasonable assurance of effectiveness for its Reducer system. The FDA’s Circulatory System Devices Advisory Panel voted 1 to 17 “against” on the issue of “a reasonable assurance of effectiveness,” according to a news release. “We would like to thank the FDA, the panel and members of […]
FDA advisory panels
FDA plans advisory panel on metal implants, dental alloys
The FDA is slated to hold an advisory panel meeting to discuss immunology concerns about metal implants and dental alloys. The Immunology Devices Panel meeting of the Medical Devices Advisory Committee is scheduled for Nov. 13-14 of this year to discuss the use of the materials and assess the adequacy of current approaches and standards […]
FDA sets meeting on EO sterilization
The FDA said today that it will hold an advisory meeting on November 6 and November 7, 2019, to discuss the role of ethylene oxide (EO) sterilization of medical devices in public health, as well as the risks of the sterilization process. The general hospital and personal use devices panel of the FDA’s medical devices […]
FDA panel recommends stiffer regulation of some surgical staplers
An FDA panel has recommended that surgical staplers for internal use be reclassified to a more highly regulated status. The General and Plastic Surgery Devices Panel met last week following a March alert the agency issued about internal-use surgical staplers. The devices have seen an uptick in concern over the past few months, with the FDA […]
FDA to publicly share advisory committee CVs
The FDA’s ongoing commitment to transparency reached a new level last week, when the agency announced it would disclose the CVs of advisory committee members. The form will not include confidential or redacted information, said FDA. Outside experts often weigh in on scientific and medical issues that pertain to new drugs and devices, and FDA has […]
