Following another media flare-up in the ongoing metal-on-metal discussion, NHS has followed UK competent authority the MHRA into releasing a positioning document of its own.
Adverse Events
FDA Warning Letter To J&J Subsidiary Diabetes Pump Company
It’s all good news for J&J as another of its divisions faces a telling off from FDA.
Covidien Contraindicates Use of Duet TRS™ For Thoracic Surgery And Implements Voluntary Recall.
Covidien has today announced that it is conducting a voluntary recall of all production lots for the Duet TRS™ Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.
Uro/Gyne Surgical Mesh Implants: FDA Updates Position
FDA has announced a heightened degree of scrutiny regarding transvaginally inserted meshes and is considering reclassifying from Class II to Class III.
FDA Reports Growth in Medical Device Adverse Events
Medtech Business reports FDA’s observations that growth in reported serious adverse events has outpaced revenue growth by 8% each year in the past decade.
UK MHRA Review of Medical Device Incidents Report Published
UK MHRA report shows 13% uplift in adverse incident reports year on year.