At the end of last week, an FDA advisory panel voted down BrainsGate’s neurostimulation device for treating stroke. BrainsGate designed its technology as a five-minute procedure. A neurostimulator implant is injected into an existing canal to stimulate a nerve center and augment collateral blood flow, improving stroke patients’ outcomes within a 24-hour window. The platform […]
FDA advisory panels
FDA advisory panel gives positive ruling on TransMedics OCS Liver System
TransMedics (NSDQ:TMDX) announced last night that an FDA advisory panel issued a favorable vote supporting approval for its OCS Liver System. Yesterday, the Nasdaq market halted trading of TransMedics’ common stock as it awaited the outcome of a meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, set to review […]
Nasdaq halts trading of TransMedics stock with FDA set to review OCS Liver System
TransMedics (NSDQ:TMDX) announced today that the Nasdaq market halted trading of the company’s common stock. Andover, Mass.-based TransMedics, which develops organ transplant transportation platforms, saw its common stock close down -5.3% at $31.69 yesterday. The company awaits the outcome of today’s meeting of the FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory […]
TransMedics says FDA advisory committee will review its OCS Liver System in July
TransMedics (NSDQ:TMDX) announced that the FDA confirmed that it will review its premarket approval application next month. Andover, Mass.–based TransMedics said the FDA scheduled a public advisory committee meeting to review the PMA application for the OCS Liver System, an organ transplant transportation platform, for July 14, 2021. In the committee meeting, the FDA’s Gastroenterology […]
FDA panel advises against assurable effectiveness of Neovasc Reducer
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 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 […]
