July 23, 2019

Vol. 16 No. 140

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Centinel Grabs IDE for Cervical Disc Clinical Trial

The devicemaker said it plans to launch the trial immediately in multiple U.S. centers that are experienced in cervical total disc replacement (TDR) procedures. Read More

European Commission Clears Up Devicemaker Vigilance Obligations

The guidance includes an updated manufacturer incident report (MIR) form that will be required for devices certified under MDD in January 2020. Read More

U.S. Device Developers Combine to Create Personalized Workflow System

Today’s imaging for severe spinal deformities is primarily used for diagnostic purposes only,” said Mike Cordonnier, cofounder and CEO of Carlsmed. “The proprietary platform we are developing enables surgeons to use this information directly for surgical intervention. Read More

Georgia Devicemaker Cited for Written MDR Procedure

The procedure did not require the firm to determine the type of report to be submitted for a complaint — five-day or 30-day. Read More