July 24, 2017

Vol. 14 No. 140

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Edap Withdraws 510(k) Device Application to Redo Clinical Data

The revised application will stay the same beyond the updated data. Read More

Voluntis Secures FDA Clearance and CE Mark for Digital Diabetes Management System

Voluntis plans to launch the system in the European market in the near future. Read More

MHRA Updates Guidance on UK Notified Bodies

The MHRA and the European Medicines Agency are intertwined, so it will be difficult for the MHRA to make a clean break. Read More

FDA Cites Peter Schiff on Validation Procedures, Record-Keeping

The facility lacked proper device history records for some devices. Read More