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FDA advisory panels

FDA panel advises against assurable effectiveness of Neovasc Reducer

October 28, 2020 By Sean Whooley

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 […]

Filed Under: Blood Management, Cardiac Implants, Cardiovascular, Featured, Food & Drug Administration (FDA), Pre-Market Approval (PMA), Regulatory/Compliance, Structural Heart Tagged With: FDA, FDA advisory panels, neovasc

FDA plans advisory panel on metal implants, dental alloys

September 30, 2019 By Sean Whooley

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 […]

Filed Under: Dental, Food & Drug Administration (FDA), Implants, Regulatory/Compliance Tagged With: FDA, FDA advisory panels

FDA sets meeting on EO sterilization

September 3, 2019 By Sean Whooley

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 […]

Filed Under: Food & Drug Administration (FDA), Sterilization / Calibration Tagged With: ethylene oxide, FDA, FDA advisory panels

FDA panel recommends stiffer regulation of some surgical staplers

June 3, 2019 By Nancy Crotti

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), News Well, Surgical Tagged With: FDA, FDA advisory panels, Popular Posts

FDA to publicly share advisory committee CVs

February 8, 2017 By Heather Thompson

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 […]

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: FDA advisory panels

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