EU drugs agency recommends suspension of Medtronic implant

(Reuters) – Europe’s medicines regulator recommended the suspension of Medtronic Plc’s Inductos, an implant used to help bone development, pending the resolution of issues at a U.S. site where a component is made. The European Medicines Agency (EMA) began a review of Inductos following an inspection by Dutch and Spanish authorities of a site that makes an absorbable sponge used in the implant. Although there is no indication of any risk to patients linked to the inspection’s findings, the regulator’s Committee for Medicinal Products for Human Use considers that the quality of Inductos cannot be assured under the current manufacturing process, the EMA said.
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