Petition Calls on FDA to Set Timeline for Designation Appeals Process March 14, 2017 Appeals for some products are particularly susceptible to delays. Read More
Oxford Performance Materials’ OsteoFab Technology Granted European Patent for 3D Printed Implants March 13, 2017 The patent protects the company’s OsteoFab process for manufacturing a three-dimensional object. Read More
Medtronic Wins FDA Clearance for Reveal Linq Insertable Cardiac Monitor with TruRhythm Detection March 13, 2017 The device monitors the patient’s heartbeat for up to three years. Read More
European Commission Grants CE Mark for PQ Bypass Devices March 13, 2017 The bypass delivers unobstructed, pulsatile flow from the superficial femoral artery ostium to the popliteal artery. Read More
FDA Expands Clearance for Spineology’s Expandable Interbody Fusion System March 13, 2017 The device implant is inserted into the disc space and expanded. Read More
Denttio Draws Warning for Complaint Evaluations, CAPA March 10, 2017 Inspectors found the facility lacked procedures for receiving, reviewing and evaluating complaints. Read More
FDA Cites Acorn Stairlifts for CAPA, Other Problems March 10, 2017 The company lacked approved procedures to ensure proper evaluation of supplier operations. Read More
Autonomic Technologies Gains Expanded Indication of CE mark for Pulsante SPG Microstimulator System March 10, 2017 The microstimulator device delivers as-needed relief for migraine patients. Read More
European Council Adopts New EU MDR, IVDR Regs March 10, 2017 The two regulations revamp the EU’s existing regulatory framework. Read More
Medical Energy Cited for Inspection, Other Procedures March 9, 2017 The firm did not have evidence that its optical fiber laser delivery system process was validated. Read More
Cooperation, Not Confrontation, Key to Internal Audits March 9, 2017 Internal audits should be used as a learning tool and teaching mechanism. Read More
FDA Awards Clearance to W. L. Gore & Associates’ Controlled Expansion for TIPS Procedures March 9, 2017 Physicians can balloon up as needed during implantation to optimize the diameter. Read More