DePuy
This article was originally published in The Gray Sheet
Executive Summary
FDA Class II recall notice erroneously lists "DePuy and Cerasive Brand Ceramic Feniral Heads" in its July 29 list of device recalls, the company says. The recalled devices were metallic femoral stems with trunions, which had been manufactured out of tolerance by the Hospital for Special Surgery in New York City. The remainder of the FDA notice is correct as stated in "The Gray Sheet" (Aug. 10, p. 14)
You may also be interested in...
Financing Quarterly Statistics, Q1 2024
During Q1, biopharmas brought in an aggregate $30.1bn in financing and device company fundraising totaled $2.8bn; while in vitro diagnostic firms and research tools players raised $724m.
Helping Organizations Deliver On KPIs And Giving Staff A Voice
ImproveWell has won awards for its software technology that allows health care staff at the sharp end of patient care to report on problems as they happen. The outcome is a real-time learning process that contributes to improved operational efficiencies for health systems, says In Vivo Rising Leader Lara Mott.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.