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Latest From David Filmore
The standards organization's board of directors approved the formation of a committee that will seek to establish consensus documents for the burgeoning sector.
US FDA says its Orthopaedic and Rehabilitation Devices Panel will convene Dec. 12 to weigh issues surrounding ongoing review of Intrinsic Therapeutics' PMA for its Barricaid anular closure device, intended to close a hole created by a spine discectomy procedure to prevent negative outcomes.
The privately held Indiana-based device firm has accelerated its 510(k)-clearance output this year, leading all firms with 19 in the third quarter, and pulling neck-and-neck with perennial leader Medtronic for 2017. Overall, FDA remains relatively steady on 510(k) volumes and is maintaining its accelerated pace of novel-device approvals.
On this week’s podcast, we discuss big announcements from US FDA on digital health policy and an upcoming device-center reorganization, as well as the recent resignation of Tom Price as health secretary.
The US agency detailed new review performance goals and user-fee policies to mark the start of a new fiscal year and five-year user-fee program.